Express™ SD Renal and Biliary Stent System

Indications, Safety, and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

EXPRESS™ SD RENAL MONORAIL™ PREMOUNTED STENT SYSTEM

INTENDED USE/INDICATIONS FOR USE

The Express SD Renal Monorail Premounted Stent System is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a single de novo or restenotic atherosclerotic lesion (≤ 15 mm in length) of the renal artery, located within 5 mm of the opacified aortic lumen and with a reference vessel diameter of 4.0 - 7.0 mm to assist in maintenance of vessel patency.

CONTRAINDICATIONS

Generally, contraindications for Percutaneous Transluminal Renal Angioplasty (PTRA) are also contraindications for stent placement. Contraindications associated with the use of the Express SD Renal Monorail Premounted Stent System include:

  • Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
  • Persons with known allergies to stainless steel or its components (for example nickel)
  • A lesion that is within or adjacent to the proximal or distal segments of an aneurysm
  • Patients with a target lesion with a large amount of adjacent acute or subacute thrombus
  • Patients with excessive vessel tortuosity
  • Patients with perforated vessels evidenced by extravasation of contrast media
  • Patients with a lesion that cannot be crossed with a wire and/or a balloon catheter

WARNINGS

Do not exceed the maximum rated burst pressure. As with any type of intravascular implant, infection, secondary to contamination of the stent, may lead to thrombosis, pseudoaneurysm or rupture into a neighboring organ or into the retroperitoneum. The stent may cause thrombus or distal emboli to migrate from the site of the implant down the arterial lumen. When stenting the renal arteries, exercise great care to reduce the risk of plaque embolization. Do not exceed the maximum expanded stent diameter. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just distal to the stenosis. Overstretching of the artery may result in rupture and life threatening bleeding. Use only diluted contrast medium for balloon inflation (typically a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium in the balloon. Persons with allergic reactions to stainless steel or its components (for example nickel) may suffer an allergic response. Do not expose the premounted stent system to organic solvents (i.e. alcohol). Patients with lesions in arteries of transplanted or bypassed kidneys are not recommended for stent implantation. The long-term outcome (beyond nine months) for this permanent implant is unknown at present. Stent placement should only be performed at hospitals where emergency peripheral artery bypass graft surgery, including renal artery bypass graft surgery, can be readily performed.

PRECAUTIONS

The device is intended for use by physicians who have been trained in interventional techniques such as percutaneous transluminal angioplasty (PTA) and placement of intravascular stents. The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspect, it should not be used. Caution should be taken with patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast medium reaction. Note: Patients with serum creatinine ≥3.0 mg/dl were excluded from the Renaissance clinical study. Prep premounted stent system per instructions given in Operational Instructions. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon. Do not attempt to pull a stent where deployment has been initiated back through a sheath or guide catheter, since dislodgment of the stent may result. If a stent that has not been fully deployed needs to be removed, the sheath or guide catheter and the premounted stent system should be removed as a unit. The SDS is not designed for use with power injection systems. Inflation at a high rate can cause damage to the balloon. Use of a pressure monitoring device is recommended to prevent over pressurization. Do not attempt to manually remove or adjust the stent on the SDS balloon. The minimally acceptable sheath and guide catheter French size is printed on the package label. Do not attempt to pass the premounted stent system catheter through a smaller size sheath or guide catheter than indicated on the label. When a premounted stent system or SDS balloon is in the body, it should be manipulated only under fluoroscopy. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Never advance the premounted stent system without the guidewire extending from the tip. Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the stent. If the target lesion is not fully covered, use an additional stent as necessary to adequately treat the lesion. It is recommended that when stenting multiple lesions, the distal lesions should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent when placing the distal stent and reduces the chances for disrupting the proximal stent. Prior to stent expansion, utilize fluoroscopy to verify the stent has not been damaged or dislodged during positioning. Expansion of the stent should not be undertaken if the stent is not appropriately positioned in the vessel. If the position of the stent is not optimal, it should not be expanded. To assure full expansion, inflate the premounted stent system to at least the opening pressure as shown on the labeling and in Table 1 in the DFU. To assure nominal sizing of the stent, inflate the premounted stent system to nominal pressure as shown on the labeling and in Table 1 in the DFU. Stenting across a bifurcation or side branch could compromise future diagnostic or therapeutic procedures, or could result in thrombosis of the side branch. More than one stent per lesion should only be used when clinically indicated for suboptimal results that compromise vessel integrity and threaten vessel closure. The second implanted stent should also be an Express® SD Renal Stent, or a stent of similar material composition, for component compatibility. Do not attempt to reposition a partially deployed stent. Attempted repositioning may result in severe vessel damage. Incomplete deployment of the stent (i.e. stent not fully opened) may cause complications resulting in patient injury. Recrossing a previously deployed stent with adjunct devices must be performed with extreme caution to ensure that the stent does not get caught within previously placed stent struts. In the event of thrombosis of the expanded stent, thrombolysis and PTRA should be attempted. In the event of complications such as infections, pseudoaneurysm, or fistulization, surgical removal of the stent may be required. Use prior to the “Use By” date. The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. The Express SD Renal Stent should not migrate in this MR environment. MR imaging at 3 T or less may be performed immediately following the implantation of the Express SD Renal Stent. In this testing, the stent experienced a maximum temperature rise of 0.96 ºC at a maximum whole body averaged SAR of 2.0 W/kg for 15 minutes of MR imaging. The temperature rise was observed to be similar for a stent with a fractured strut. The maximum temperature rise observed for two overlapping Express SD stents was 1.15 ºC (5 mm overlap at the ends). MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent. This stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 3T. 

ADVERSE EVENTS

Potential complications associated with the use of vascular stents may include, but are not limited to:

  • Abscess
  • Acute myocardial infarction
  • Acute or sub acute thrombosis
  • Aneurysm
  • Arrhythmias, including VF and VT
  • Artery injury, including perforation and dissection
  • AV fistula
  • Bowel infarct
  • Death
  • Drug reaction, allergic reaction to contrast medium
  • Emboli or air
  • Embolization of atherosclerotic thrombotic materials
  • Emergency surgery to correct vascular complications
  • Extremity ischemia/amputation
  • GI symptoms from anticoagulation/antiplatelet medication
  • Hemorrhage/Hematoma
  • Hypotension or Hypertension Intimal tear
  • Kidney infarct
  • Nephrectomy
  • Pseudoaneurysm formation
  • Renal failure
  • Restenosis of the stented artery
  • Rupture of retro-peritoneum or of neighboring organ
  •  Rupture, overstretching of vessel
  • Sepsis/Infection
  • Stent embolization
  • Stent migration
  • Stent misplacement
  • Stroke or other cerebrovascular accidents
  • Thromboembolic event
  • Tissue necrosis
  • Total occlusion

EXPRESS™ SD BILIARY MONORAIL™ PREMOUNTED STENT SYSTEM

INTENDED USE/INDICATIONS FOR USE

The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

CONTRAINDICATIONS

Contraindications associated with the use of the Express SD Biliary Monorail Premounted Stent System as a transhepatic endoprosthesis include:

  • Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis.
  • Patients with bleeding disorders.
  • Severe ascites.

WARNINGS

  • Use only diluted contrast medium for balloon inflation (typically a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium in the balloon.
  • Prepare Premounted Stent System per instructions given. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon.
  • Do not exceed the maximum rated burst pressure.
  • Persons with allergic reactions to stainless steel may suffer an allergic response to the implant.
  • Do not expose the Premounted Stent System to organic solvents (i.e. alcohol).
  • To reduce the potential for patient injury, the inflated diameter of the balloon should approximate the diameter of the duct just proximal and distal to the stricture. Overstretching of the duct may result in patient injury.
  • The Express SD Biliary Stent may cause image artifacts with MRI scans due to distortion of the magnetic field.
  • Stenting across a bifurcation could compromise future diagnostic or therapeutic procedures.

PRECAUTIONS

  • The device is intended for use by physicians who have received appropriate training.
  • The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspect, it should not be used.
  • Do not attempt to pull a stent that has not been expanded back through an introducer sheath, since dislodgment of the stent may result. If a stent that has not been expanded needs to be removed, the introducer sheath and the Premounted Stent System should be removed as a unit.
  • When treating multiple strictures, the stricture distal to the puncture site should be initially stented, followed by stenting of the proximal stricture. Stenting in this order eliminates the need to cross the proximal stent to achieve placement of the distal stent, and reduces the chance for dislodging the proximal stent with the SDS balloon or Premounted Stent System or dislodging the stent from the SDS balloon.
  • The Premounted Stent System is not designed for use with power injection systems. Inflation at a high rate can cause damage to the balloon. Use of a pressure monitoring device is recommended to prevent over pressurization.
  • Do not attempt to manually remove or adjust the stent on the SDS balloon.
  • The minimally acceptable introducer sheath French size is printed on the package label. Do not attempt to pass the pre-mounted stent system through a smaller size introducer sheath than indicated on the label.
  • When catheters are in the body, they should be manipulated only under fluoroscopy. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.
  • Never advance the Premounted Stent System without the guidewire extending from the tip.
  • Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the stent. If the target stricture is not fully covered, use additional stents as necessary to adequately treat the stricture.
  • To ensure expansion of the premounted stent, inflate the Premounted Stent System to at least the opening pressure as shown on the label. To assure nominal sizing of the stent, inflate the Premounted Stent System to nominal pressure as shown on the label.
  • Prior to stent expansion, utilize high-resolution fluoroscopy to verify the stent has not been damaged or dislodged during positioning. Expansion of the stent should not be undertaken if the stent is not appropriately positioned in the duct. If the position of the stent is not optimal, it should not be expanded.
  • Do not attempt to reposition a partially deployed stent. Attempted repositioning may result in patient injury. Incomplete deployment of the stent (i.e. stent not fully opened) may cause complications resulting in patient injury.
  • Recrossing a previously deployed stent with adjunct devices must be performed with extreme caution.
  • In the event of complications (such as infections), surgical removal of the stent may be required. Standard surgical procedure is appropriate.
  • When multiple stents are required, if placement results in metal to metal contact, stent materials should be of similar composition.
  • The Express SD Biliary Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. The Express SD Biliary Stent should not migrate in this MR environment. MR imaging at 3 T or less may be performed immediately following the implantation of the Express SD Biliary Stent.
  • In this testing, the stent experienced a maximum temperature rise of 0.96˚C at a maximum whole body averaged SAR of 2.0 W/kg for 15 minutes of MR imaging. The temperature rise was observed to be similar for a stent with a fractured strut. The maximum temperature rise observed for two overlapping Express SD stents was 1.15˚C (5 mm overlap at the ends). MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent.
  • This stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 3T.

ADVERSE EVENTS

Potential complications associated with biliary stenting may include, but are not limited to:

  • Abscess
  • Sepsis/infection
  • Stent migration
  • Stent misplacement
  • Hemorrhage/Hematoma
  • Bile duct injury, including perforation, rupture and dissection
  • Total occlusion/obstruction
  • Stent embolization
  • Drug reaction, allergic reaction to contrast medium
  • Death
  • Tumor overgrowth at the stent ends
  • Parenchymal hemorrrhage
  • Hemobilia
  • Peritonitis
  • Cholangitis
  • Stent obstruction secondary to tumor growth through the stent
  • Pancreatitis

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