Indications, safety and warnings for EMBOLD™ (Soft/Packing/Fibered) Detachable Coil System

EMBOLD Fibered Detachable Coil System

The EMBOLD Fibered Detachable Coil System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

EMBOLD Packing Detachable Coil System

The EMBOLD Packing Detachable Coil System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

EMBOLD Soft Detachable Coil System

The EMBOLD Soft Detachable Coil System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

There are no known contraindications.

EMBOLD Fibered Detachable Coil System

The following warning statements provide important information for safe use of EMBOLD Fibered Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• Do not use the EMBOLD Fibered Detachable Coil System if it is damaged.
• To reduce the risk of thromboembolic complications, it is critical that a continuous flow of appropriate flush solution be maintained between a) the microcatheter and guide catheter, and b) the microcatheter and any intraluminal device.
• If undesirable movement of the coil can be seen under fluoroscopy after coil placement and before detachment, remove the coil and replace with another more appropriately sized EMBOLD Fibered Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached.
• Axial compression or tension forces may be stored in the microcatheter shaft during EMBOLD Fibered Detachable Coil delivery, and coil release may lead to catheter tip movement. Verify repeatedly during the procedure that the distal shaft of the microcatheter is not under stress prior to detachment by slightly repositioning the microcatheter, delivery wire, or entire assembly simultaneously. Coil release without relieving stored forces may lead to catheter tip movement, which could cause vessel trauma.
• Due to the delicate nature of coils and the tortuosity that can be present in vasculature pathways, as well as various morphologies of vasculature, the coil may become stretched during delivery and repositioning. Stretching is a precursor to potential coil breakage. The coil should respond in approximately a 1:1 motion with the delivery system. If the coil does not move in a 1:1 motion, or if advancement after retraction or repositioning is significantly more challenging or impossible, this may be an indicator of coil stretching. If stretching is observed or suspected, carefully remove the coil and microcatheter from the vasculature simultaneously.
• Do not retract the EMBOLD Fibered Detachable Coil System too quickly or against resistance. Doing so may result in a stretched coil, premature detachment of the coil, or other damage to the coil or delivery system.
• The coil may detach prematurely if the detachment mechanism (located near the proximal end of the delivery wire) is activated before intended. Use caution when handling this portion of the delivery system prior to coil detachment. Follow all instructions when introducing and positioning the coil to avoid prematurely detaching the coil.
• Do not rotate the delivery wire more than 1 turn (360 degrees) during delivery of the EMBOLD Fibered Detachable Coil System. Excessive rotation of the delivery wire may damage the EMBOLD Fibered Detachable Coil System or may result in premature detachment of the coil.
• Do not advance the delivery wire once the coil has been detached. Vessel trauma could occur.

EMBOLD Packing Detachable Coil System

The following warning statements provide important information for safe use of EMBOLD Packing Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• Do not use the EMBOLD Packing Detachable Coil System if it is damaged.
• To reduce the risk of thromboembolic complications, it is critical that a continuous flow of appropriate flush solution be maintained between a) the microcatheter and guide catheter, and b) the microcatheter and any intraluminal device.
• If undesirable movement of the coil can be seen under fluoroscopy after coil placement and before detachment, remove the coil. Movement of the coil may indicate the coil could migrate once it is detached. Consider adding an alternative coil (such as a backstop, framing, or finishing coil), or consider finding alternative anatomy to restrain the coil.
• Axial compression or tension forces may be stored in the microcatheter shaft during EMBOLD Packing Detachable Coil delivery, and coil release may lead to catheter tip movement. Verify repeatedly during the procedure that the distal shaft of the microcatheter is not under stress prior to detachment by slightly repositioning the microcatheter, delivery wire, or entire assembly simultaneously. Coil release without relieving stored forces may lead to catheter tip movement, which could cause vessel trauma.
• Due to the delicate nature of coils and the tortuosity that can be present in vasculature pathways, as well as various morphologies of vasculature, the coil may become stretched during delivery and repositioning. Stretching is a precursor to potential coil breakage. The coil should respond with the delivery system movement. If movement of the coil is not observed, or if advancement after retraction or repositioning is significantly more challenging or impossible, this may be an indicator of coil stretching. Additionally, reduced radiopacity may be indicative of coil stretching. If stretching is observed or suspected, careful removal of the coil and microcatheter from the vasculature simultaneously is recommended.
• Do not retract the EMBOLD Packing Detachable Coil System too quickly or against resistance. Doing so may result in a stretched coil, premature detachment of the coil, or other damage to the coil or delivery system.
• The coil may detach prematurely if the detachment mechanism (located near the proximal end of the delivery wire) is activated before intended. Use caution when handling this portion of the delivery system prior to coil detachment. Follow all instructions when introducing and positioning the coil to avoid prematurely detaching the coil.
• Do not rotate the delivery wire more than 1 turn (360 degrees) during delivery of the EMBOLD Packing Detachable Coil System. Excessive rotation of the delivery wire may damage the EMBOLD Packing Detachable Coil System or may result in premature detachment of the coil.
• Do not advance the delivery wire once the coil has been detached. Vessel trauma could occur.

EMBOLD Soft Detachable Coil System

The following warning statements provide important information for safe use of EMBOLD Soft Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• Do not use the EMBOLD Soft Detachable Coil System if it is damaged.
• To reduce the risk of thromboembolic complications, it is critical that a continuous flow of appropriate flush solution be maintained between a) the microcatheter and guide catheter, and b) the microcatheter and any intraluminal device.
• If undesirable movement of the coil can be seen under fluoroscopy after coil placement and before detachment, remove the coil and replace with another more appropriately sized EMBOLD Soft Detachable Coil. Movement of the coil may indicate the coil could migrate once it is detached.
• Axial compression or tension forces may be stored in the microcatheter shaft during EMBOLD Soft Detachable Coil delivery, and coil release may lead to catheter tip movement. Verify repeatedly during the procedure that the distal shaft of the microcatheter is not under stress prior to detachment by slightly repositioning the microcatheter, delivery wire, or entire assembly simultaneously. Coil release without relieving stored forces may lead to catheter tip movement, which could cause vessel trauma.
• Due to the delicate nature of coils and the tortuosity that can be present in vasculature pathways, as well as various morphologies of vasculature, the coil may become stretched during delivery and repositioning. Stretching is a precursor to potential coil breakage. The coil should respond with the delivery system movement. If movement of the coil is not observed, or if advancement after retraction or repositioning is significantly more challenging or impossible, this may be an indicator of coil stretching. Additionally, reduced radiopacity may be indicative of coil stretching. If stretching is observed or suspected, careful removal of the coil and microcatheter from the vasculature simultaneously is recommended.
• Do not retract the EMBOLD Soft Detachable Coil System too quickly or against resistance. Doing so may result in a stretched coil, premature detachment of the coil, or other damage to the coil or delivery system.
• The coil may detach prematurely if the detachment mechanism (located near the proximal end of the delivery wire) is activated before intended. Use caution when handling this portion of the delivery system prior to coil detachment. Follow all instructions when introducing and positioning the coil to avoid prematurely detaching the coil.
• Do not rotate the delivery wire more than 1 turn (360 degrees) during delivery of the EMBOLD Soft Detachable Coil System. Excessive rotation of the delivery wire may damage the EMBOLD Soft Detachable Coil System or may result in premature detachment of the coil.
• Do not advance the delivery wire once the coil has been detached. Vessel trauma could occur.

EMBOLD Fibered Detachable Coil System

The following precaution statements provide important information for safe use of EMBOLD Fibered Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• To ensure safe delivery, never make sudden movements, do not force in case of resistance, and operate gently and with caution.
• Ensure the microcatheter in use has the appropriate ID and length for the selected coil.
• Do not apply excessive force while seating the introducer sheath in the microcatheter hub. Introducer sheath tip deformation and difficulty with coil delivery into the microcatheter could result.
• Do not advance the EMBOLD Fibered Detachable Coil System if it becomes lodged within the microcatheter. Determine the cause of the resistance and replace the microcatheter and coil if necessary. See the “Operational Instructions – Full System Removal” section for further instructions.
• Advance and retract the EMBOLD Fibered Detachable Coil System smoothly, especially in tortuous anatomy. Replace the coil if unusual friction is noted within the microcatheter. If friction is noted in any successive coil, carefully examine both coil and microcatheter for possible damage. Replace both if necessary.
• If resistance is encountered or if the coil is not responding in a 1:1 motion while retracting the EMBOLD Fibered Detachable Coil System and the coil is at an acute angle relative to the microcatheter tip, it may be possible to avoid coil stretching by carefully pulling back the distal tip of the microcatheter slightly before continuing to retract the coil.
• No tools are required to detach the coil. Using a tool could result in damage to the inner wire causing the coil to be difficult or impossible to release.
• When in highly tortuous anatomy, increased resistance may be felt when retracting the inner wire and a greater retraction distance may be required to detach the coil.
• During verification of coil detachment, if coil retraction into the microcatheter is observed and the inner wire between the detachment indicator marks has been exposed, the implant may detach as soon as the coil detachment zone is advanced beyond the microcatheter tip. Ensure catheter tip position is satisfactory and is maintained during this step to reduce the potential for malpositioning of the proximal portion of the coil.
• Multiple embolization coils may be required to achieve the desired occlusion.
• Replace microcatheters periodically during delivery of multiple coils or if increased resistance is noted during coil delivery.

EMBOLD Packing Detachable Coil System

The following precaution statements provide important information for safe use of EMBOLD Packing Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• To ensure safe delivery, never make sudden movements, do not force in case of resistance, and operate gently and with caution.
• Ensure the microcatheter in use has the appropriate ID and length for the selected coil.
• Do not apply excessive force while seating the introducer sheath in the microcatheter hub. Introducer sheath tip deformation and difficulty with coil delivery into the microcatheter could result.
• Do not advance the EMBOLD Packing Detachable Coil System if it becomes lodged within the microcatheter. Determine the cause of the resistance and replace the microcatheter and coil if necessary. See the “Operational Instructions – Full System Removal” section for further instructions.
• Advance and retract the EMBOLD Packing Detachable Coil System smoothly, especially in tortuous anatomy. Replace the coil if unusual friction is noted within the microcatheter. If friction is noted in any successive coil, carefully examine both coil and microcatheter for possible damage. Replace both if necessary.
• If resistance is encountered or if the coil is not responding while retracting the EMBOLD Packing Detachable Coil System and the coil is at an acute angle relative to the microcatheter tip, it may be possible to avoid coil stretching by carefully pulling back the distal tip of the microcatheter slightly before continuing to retract the coil.
• No tools are required to detach the coil. Using a tool could result in damage to the inner wire causing the coil to be difficult or impossible to release.
• When in highly tortuous anatomy, increased resistance may be felt when retracting the inner wire and a greater retraction distance may be required to detach the coil.
• During verification of coil detachment, if coil retraction into the microcatheter is observed and the inner wire between the detachment indicator marks has been exposed, the implant may detach as soon as the coil detachment zone is advanced beyond the microcatheter tip. Ensure catheter tip position is satisfactory and is maintained during this step to reduce the potential for malpositioning of the proximal portion of the coil.
• Multiple embolization coils may be required to achieve the desired occlusion.
• Replace microcatheters periodically during delivery of multiple coils or if increased resistance is noted during coil delivery.

EMBOLD Soft Detachable Coil System

The following precaution statements provide important information for safe use of EMBOLD Soft Detachable Coil System. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in patient injury or product damage.

• To ensure safe delivery, never make sudden movements, do not force in case of resistance, and operate gently and with caution.
• Ensure the microcatheter in use has the appropriate ID and length for the selected coil.
• Do not apply excessive force while seating the introducer sheath in the microcatheter hub. Introducer sheath tip deformation and difficulty with coil delivery into the microcatheter could result.
• Do not advance the EMBOLD Soft Detachable Coil System if it becomes lodged within the microcatheter. Determine the cause of the resistance and replace the microcatheter and coil if necessary. See the “Operational Instructions – Full System Removal” section for further instructions.
• Advance and retract the EMBOLD Soft Detachable Coil System smoothly, especially in tortuous anatomy. Replace the coil if unusual friction is noted within the microcatheter. If friction is noted in any successive coil, carefully examine both coil and microcatheter for possible damage. Replace both if necessary.
• If resistance is encountered or if the coil is not responding while retracting the EMBOLD Soft Detachable Coil System and the coil is at an acute angle relative to the microcatheter tip, it may be possible to avoid coil stretching by carefully pulling back the distal tip of the microcatheter slightly before continuing to retract the coil.
• No tools are required to detach the coil. Using a tool could result in damage to the inner wire causing the coil to be difficult or impossible to release.
• When in highly tortuous anatomy, increased resistance may be felt when retracting the inner wire and a greater retraction distance may be required to detach the coil.
• During verification of coil detachment, if coil retraction into the microcatheter is observed and the inner wire between the detachment indicator marks has been exposed, the implant may detach as soon as the coil detachment zone is advanced beyond the microcatheter tip. Ensure catheter tip position is satisfactory and is maintained during this step to reduce the potential for malpositioning of the proximal portion of the coil.
• Multiple embolization coils may be required to achieve the desired occlusion.
• Replace microcatheters periodically during delivery of multiple coils or if increased resistance is noted during coil delivery.

EMBOLD Fibered Detachable Coil System

Potential adverse events which may be associated with the use of a coil and/or the peripheral embolization procedure include, but are not limited to:

• Allergic reaction (device, contrast, medications)
• Arrhythmia
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA)
• Death
• Embolism (air, plaque, thrombus, device, tissue, or other)
• Hematoma
• Infection/sepsis
• Ischemia
• Necrosis
• Need for additional intervention or surgery
• Nerve injury
• Pain/discomfort
• Post-embolization syndrome (PES)
• Recanalization
• Thrombus/thrombosis
• Transient ischemic attack (TIA)
• Vasospasm
• Vessel trauma (arteriovenous fistula, dissection, injury, perforation, pseudoaneurysm, rupture)

EMBOLD Packing Detachable Coil System/ EMBOLD Soft Detachable Coil System

Potential adverse events which may be associated with the use of a coil and/or the peripheral embolization procedure include, but are not limited to:

• Allergic reaction (device, contrast, medications, or other)
• Arrhythmia
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA)
• Death
• Embolism (air, plaque, thrombus, device, tissue, or other)
• Hematoma
• Infection/sepsis
• Ischemia
• Necrosis
• Need for additional intervention or surgery
• Nerve injury
• Pain/discomfort
• Post-embolization syndrome (PES)
• Recanalization
• Thrombus/thrombosis
• Transient ischemic attack (TIA)
• Vasospasm
• Vessel trauma (arteriovenous fistula, dissection, injury, perforation, pseudoaneurysm, rupture, or other)