Jostent GraftMaster Coronary Stent Graft System (U.S.)

Product Specifications

*The length of the ePTFE foil is shorter than the reported strut length.
After expansion of the stent, the ePTFE foil may be up to 1.6 mm from each end of the stent graft. The covered length of the stented area may be up to 3.2 mm shorter than the stent length. This information must be considered when choosing an appropriately sized stent graft.

Compliance Chart

*Minimum deployment pressure
**Rated burst pressure

Ordering Information

IRB approval required for use

Indications and Important Safety Information

Jostent GraftMaster Coronary Stent Graft System

IRB approval required for use

JOSTENT® GraftMaster Coronary Stent Graft

HUMANITARIAN USE DEVICE

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 anticoagulation 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 of 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

(See also Individualization of Treatment)

• 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 long term 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 the Delivery System 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 System. This is most important during placement 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 section 9.3 of the IFU – 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 additional 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 monitored 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 potential intimal damage and dissection.

• Do not attempt to pull an 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 implantation, 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:

• Maintain guide wire placement across the lesion and carefully pull 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 catheter.

• The guiding catheter and 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 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 guide wire, or balloon catheter, to avoid disrupting the Stent Graft geometry.

• Do not perform Magnetic Resonance Imaging (MRI) scans 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.

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) that may be associated with the use of JOSENT® Coronary Graft in native coronary arteries may include:

• Acute myocardial infarction • Arrhythmias (including VF and VT) • Coronary Artery Bypass Surgery • Death • Dissection • Drug reactions to antiplatelet agents/contrast medium • Emboli, distal (air, tissue or thrombotic emboli) • Emergent Coronary Artery Bypass Surgery •Hypotension / Hypertension • Infection and pain at insertion site • Ischemia, myocardial • Perforation • Pseudoaneurysm, femoral • Restenosis of stented segment • Spasm • Stent Graft embolization • Stent Graft thrombosis / occlusion • Stroke/Cerebrovascular Accidents • Total occlusion of coronary artery

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