Instructions for Use - Jostent GraftMaster

INDICATIONS

The JOSTENT GraftMaster is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts > 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated. Long-term outcome for this permanent implant is unknown at present.

CONTRAINDICATIONS

The JOSTENT GraftMaster is contraindicated for use in:

• Patients in whom antiplatelet and/or anticoagualtion therapy is contraindicated.

• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.

WARNINGS

• Since the use this device carries the associated risk subacute thrombosis, vascular complications, and/or bleeding events, judicious selection of patients is necessary.

• Patients allergic to surgical stainless steel or PTFE may suffer an allergic reaction to this implant.

PRECAUTIONS

• Only physicians who have received appropriate angioplasty training should perform implantation of the stent graft.

• Stent graft placement should only be performed at hospitals where emergency coronary artery bypass surgery can be readily performed.

• Subsequent restenosis may require re-dilation of the arterial segment containing the stent graft. The longterm outcome following repeat dilatation of coronary stents is unknown.

• When multiple stents are required, stent materials should be of similar composition.

STENT GRAFT HANDLING - PRECAUTIONS

• For single use only. Do not resterilize or reuse. Note product "Use Before" date.

• Do not remove the stent graft from its Delivery System. Removing the stent graft from its delivery balloon may damage the stent graft and/or lead to stent graft embolization.

• Special care must be taken not to handle or in any way disrupt the stent graft position on the delivery device. This is most important during placement over the guide over the guide wire and advancement through the hemostasis valve adaptor and guiding catheter hub.

• Excessive manipulation (e.g., rolling the mounted stent graft) may cause dislodgment of the stent graft from the delivery balloon.

• Use only appropriate balloon inflation media. Do not use air or any gas medium to inflate the balloon as it may cause uneven expansion and difficulty in deployment of the stent graft.

STENT GRAFT PLACEMENT - PRECAUTIONS

• Do not prepare or pre-inflate balloon prior to stent graft deployment other than as directed. Use the balloon purging technique described in 10.3, System Preparation.

• Implanting a stent graft may lead to dissection of the vessel distal and/or proximal to the stent graft, and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation, placement of addional stents, or other).

• If more than one stent graft is required, the distal stent graft should be placed initially, followed by placement of the proximal stent graft. Stent graft placement in this order obviates the need to cross the proximal stent graft when placing the distal stent graft, and reduces the chances for dislodging the proximal stent graft.

• Do not expand the stent graft if it is not properly positioned in the vessel (See Stent Graft/System Removal - Precautions)

• Placement of the stent graft will compromise side branch patency.

• Balloon pressures should be monitred during inflation. Do not exceed rated burst pressure as indicated on product label. Use of pressures higher than specified on the product label may possibly result in a ruptured balloon and potentail intimal damage and dissection.

• Do not attempt to pull an unexpanded stent graft back through the guiding catheter; dislodgment of the stent graft from the balloon may occur. (See stent Graft/System Removal - Precautions)

• Stent graft retrieval methods (use of additional wires, snares, and/or forceps) may result in additional trauma to the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.

STENT GRAFT/SYSTEM REMOVAL - PRECAUTIONS

Should unusual resistance be felt at any time, either during lesion access or during removal of the Delivery System post-stent graft implatation, the Delivery System and guiding catheter should be removed as a single unit. This must be done under direct visualization of fluoroscopy.

When removing the Delivery System as a single unit:

• It's recommended maintaining guidewire placement across the lesion and carefully pulling back the delivery system until the proximal balloon marker of the delivery system is aligned with the distal tip of the guiding catheter. Do not pull the Delivery System into the guiding cathter.

• The guiding catheter and Stent Graft Delivery system should be carefully removed from the coronary artery as a single unit.

• The system should be pulled back into the descending aorta toward the arterial sheath. As the distal end of the guiding catheter enters into the arterial sheath, the catheter will straighten allowing safe withdrawal of the Stent Graft Delivery System into the guiding catheter, and the subsequent removal of the Stent Graft Delivery System from the arterial sheath.

• Failure to follow these steps and/or applying excessive force to the Delivery System can potentially result in loss or damage to the stent graft or Delivery System components such as the balloon. If it is necessary to retain guide wire position for subsequent artery/lesion access, leave the guide wire in place and remove all the other components.

POST-STENT GRAFT PLACEMENT - PRECAUTIONS

• Care must be exercised when crossing a newly deployed stent graft with an intravascular ultrasound (IVUS), or a coronary guidewire, or balloon catheter, to avoid disrupting the stent graft geometry.

• Do not perform Magnetic Resonance Imaging (MRI) scan on patients post-stent graft implantation until the stent graft has been completely endothelialized (eight weeks) to minimize the potentail for migration. The stent graft may cause artifacts in MRI scans due to distortion of the magnetic field.

ADVERSE EFFECTS

The following adverse effects have been reported and may occur:

• Procedural Complications
• Pericardial effusion
• Tamponade
• Pericardiocentesis
• Cardiac arrest
• Hypotension
• Cardiogenic shock
• Bradycardia

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