Brief Summary Statement

Product

WATCHMAN FXD Curve™ Access System – IFU 52212464

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The WATCHMAN FXD Curve Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

CONTRAINDICATIONS

Do not use the WATCHMAN FXD Curve Access System if:

• Intracardiac thrombus is present.
• An atrial septal defect repair or closure device is present.
• A patent foramen ovale repair or closure device is present.
• Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
• There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.

For additional contraindications associated with the Closure Device, refer to LAAC Implant IFU.

WARNINGS

Use of the WATCHMAN FXD Curve Access System for implantation of the family of WATCHMAN FLX LAAC Devices should only be performed by interventional cardiologists and/or electrophysiologists who are educated in percutaneous and transseptal procedures and who have completed the required WATCHMAN FLX family Physician Training program.

• For single use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the Access Sheath and/or lead to Access Sheath failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the Access Sheath and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the Access Sheath may lead to injury, illness, or death of the patient.
• The WATCHMAN FXD Curve Access Sheath should not be used with any WATCHMAN Device that requires the use of a proximal marker band placed at, or just distal to LAA ostium prior to deployment.
• Careful consideration should be given to use of the Access Sheath in pregnant and/or breastfeeding women due to the risk of significant exposure to X-rays and the use of anticoagulation medication.
• Patients under deep or conscious sedation are at increased risk for having negative left atrial pressures, especially in the presence of hypovolemia or partial upper airway obstruction. Patients under positive pressure ventilation such as general anesthesia have reduced risk of negative atrial pressures. Negative left atrial pressures may increase the risk of air ingress through the hemostasis valve, particularly when the hemostasis valve is open while introducing, removing, or exchanging devices, which may result in air embolism. The most appropriate anesthesia method should be based on individual patient characteristics. Additional caution should be used with patients under deep or conscious sedation, such as:           
•     Ensure the patient is not hypovolemic.
•     Make device exchanges with the hemostasis valve below the level of the heart or submerged in fluid, and withdraw devices slowly until the distal tip is near the valve, then make exchanges during expiration.

For additional warnings associated with the Closure Device, refer to LAAC Implant IFU.

PRECAUTIONS

• The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying, recapturing, and repositioning the Closure Device. 
• Use caution when introducing any WATCHMAN FXD Curve Access System to prevent damage to cardiac structures.
• Use caution when introducing Delivery System to prevent damage to cardiac structures.
• To prevent damage to the Delivery Catheter or Closure Device, do not allow the Closure Device to protrude beyond the Delivery Catheter when inserting the Delivery System into an Access Sheath.  
  

For additional precautions associated with the Closure Device, refer to LAAC Implant IFU.

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a LAAC Device or implantation procedure include but are not limited to:  

• Air embolism
• Airway trauma
• Allergic reaction to contrast media, anesthetic, Closure Device material, or medications
• Altered mental status
• Anemia requiring transfusion
• Anesthesia risks
• Angina
• Anoxic encephalopathy
• Arrhythmias
• Atrial septal defect
• Bruising, hematoma, or seroma near the catheter insertion site
• Cardiac perforation
• Chest pain/discomfort
• Confusion post-procedure
• Congestive heart failure
• Contrast-related nephropathy
• Cranial bleed
• Death
• Decreased hemoglobin
• Deep vein thrombosis
• Device embolism
• Device fracture
• Device thrombosis
• Edema
• Embolism
• Excessive bleeding
• Fever
• Fistula
• Groin pain
• Groin puncture bleed
• Hematuria
• Hemoptysis
• Hypotension
• Hypoxia
• Improper wound healing
• Inability to reposition, recapture, or retrieve the device
• Infection/pneumonia
• Interatrial septum thrombus
• Intratracheal bleeding
• Major bleeding requiring transfusion
• Misplacement of the device/improper seal of the appendage/movement of device from appendage wall
• Myocardial erosion
• Myocardial infarction
• Nausea
• Oral bleeding
• Pericardial effusion/tamponade
• Pleural effusion
• Prolonged bleeding from a laceration
• Pseudoaneurysm
• Pulmonary edema
• Radiation injury
• Renal failure
• Respiratory insufficiency/failure
• Stroke - Hemorrhagic
• Stroke - Ischemic
• Surgical removal of the device
• TEE complications (e.g., throat pain, bleeding, esophageal trauma)
• Thrombocytopenia
• Thrombosis
• Transient ischemic attack (TIA)
• Valvular or vascular damage
• Vasovagal reactions
  

There may be other potential adverse events that are unforeseen at this time.

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