GRAFTMASTER™ RX Coronary Stent Graft System
The GRAFTMASTER™ RX Coronary Stent Graft System 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.
Humanitarian Use Device
The effectiveness of this device for this use has not been demonstrated. IRB approval required for use.
GRAFTMASTER™ Diameter | 2.8 - 4.0 mm | 4.5 - 4.8 mm |
---|
Stent Material | Stainless Steel 316L | Stainless Steel 316L |
Graft Material | Expandable Polytetrafluoroethylene (ePTFE) sandwiched between two identical stents | Expandable Polytetrafluoroethylene (ePTFE) sandwiched between two identical stents |
Double Wall Thickness (mm) | 0.52 | 0.52 |
Balloon Type | Semi Compliant | Semi Compliant |
Shaft Size (F) | 2.4 - 2.8 | 2.4 - 2.8 |
Nominal Deployment Pressure (ATM) | 15 | 15 |
Rated Burst Pressure (ATM) | 16 | 16 |
Maximum Guide Wire (in) | 0.014 | 0.014 |
Total Length (cm) | 143 | 143 |
Maximum Stent Graft Expansion (mm)* | 5.5 | 5.5 |
Minimum Guide Catheter (in) / (F) | 0.068 / ≥ 6 | 0.074 / ≥ 7 |
Crimped Stent Profile (in) | 0.064 | 0.068 |
Tip Entry Profile (in) | 0.024 | 0.024 |
Maximum Crossing Profile (in) | 0.064 | 0.068 |
Product specification data on file at Abbott.
*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
Inner Diameter Compliance Chart
ATM | 2.80 MM | 3.50 MM | 4.00 MM | 4.50 MM | 4.80 MM |
---|
11 | 1.37 | 1.83 | 2.30 | 2.86 | 2.98 |
12 | 1.67 | 2.34 | 2.74 | 3.20 | 3.57 |
13 | 1.91 | 2.47 | 2.90 | 3.30 | 3.89 |
14 | 2.08 | 2.63 | 3.08 | 3.52 | 3.98 |
15 (NOM) | 2.18 | 2.81 | 3.31 | 3.79 | 4.16 |
16 (RBP) | 2.32 | 3.01 | 3.54 | 3.98 | 4.34 |
17 | 2.47 | 3.19 | 3.72 | 4.15 | 4.52 |
18 | 2.62 | 3.32 | 3.86 | 4.31 | 4.64 |
19 | 2.73 | 3.43 | 3.96 | 4.42 | 4.77 |
Outer Diameter Compliance Chart
ATM | 2.80 MM | 3.50 MM | 4.00 MM | 4.50 MM | 4.80 MM |
---|
11 | 1.89 | 2.35 | 2.82 | 3.38 | 3.50 |
12 | 2.19 | 2.86 | 3.26 | 3.72 | 4.09 |
13 | 2.43 | 2.99 | 3.42 | 3.82 | 4.41 |
14 | 2.60 | 3.15 | 3.60 | 4.04 | 4.50 |
15 (NOM) | 2.70 | 3.33 | 3.83 | 4.31 | 4.68 |
16 (RBP) | 2.84 | 3.53 | 4.06 | 4.50 | 4.86 |
17 | 2.99 | 3.71 | 4.24 | 4.67 | 5.00 |
18 | 3.14 | 3.84 | 4.38 | 4.83 | 5.16 |
19 | 3.25 | 3.95 | 4.48 | 4.94 | 5.29 |
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.
Ordering Information
Humanitarian Use Device
The effectiveness of this device for this use has not been demonstrated.
IRB approval required for use.
GRAFTMASTER™ RX |
---|
Stent Graft Diameter (mm) | Stent Graft Length (mm) | 6F/7F (Guide) |
16 | 19 | 26 |
2.8 | 1012580-16 | 1012580-19 | 1012580-26 | 6 |
3.5 | 1012581-16 | 1012581-19 | 1012581-26 | 6 |
4.0 | 1012582-16 | 1012582-19 | 1012582-26 | 6 |
4.5 | 1012583-16 | 1012583-19 | 1012583-26 | 7 |
4.8 | 1012584-16 | 1012584-19 | 1012584-26 | 7 |
Important Safety Information
GRAFTMASTER™ RX
Coronary Stent Graft System
Humanitarian Device
Humanitarian Device. Authorized by Federal Law for the 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.
Indications
The GRAFTMASTER™ RX 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
GRAFTMASTER™ RX is contraindicated for use in:
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
- Patients who are judged to have a treatment area that prevents complete inflation of an angioplasty balloon or proper placement of the stent graft.
Warnings
- Ensure that the sterile barrier has not been opened or damaged prior to use.
- Judicious selection of patients is necessary, since the use of this device carries the associated risk of subacute thrombosis, vascular complications, and / or bleeding events.
- Persons allergic to 316L stainless steel (including the major elements iron, chromium, nickel, molybdenum) or PTFE may suffer an allergic reaction to this implant.
- When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different metals in contact with each other may increase the potential for corrosion. The risk of in vivo corrosion does not appear to increase based on in vitro corrosion tests using an L-605 CoCr alloy stent (MULTI-LINK VISION® Coronary Stent) in combination with a 316L stainless steel alloy stent (MULTI-LINK TETRA Coronary Stent).
Precautions
General Precautions
(See also Individualization of Treatment in IFU)
- Implantation of the stent graft should be performed only by physicians who have received appropriate training.
- Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent graft. The long-term outcome following repeat dilatation of endothelialized stent grafts is unknown at present.
- Care should be taken to control the guiding catheter tip during stent graft delivery, deployment, and balloon withdrawal. Before withdrawing the stent graft delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
- Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.
- Note the product “Use by” date specified on the package.
Stent Graft Handling – Precautions
- This device is intended for single-use only; do not reuse. Do not resterilize, as this can compromise the device performance and increase the risk of cross contamination due to inappropriate reprocessing.
- 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.
- The delivery system should not be used in conjunction with other stents.
- 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 adapter and guiding catheter hub.
- Excessive manipulation (e.g., rolling the mounted Stent Graft) may cause dislodgment of the Stent Graft from the delivery balloon.
- Do not manipulate, touch, or handle the stent graft with your fingers, as this may cause contamination or dislodgement 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 Preparation - 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 10.2.3 of the GRAFTMASTER™ RX IFU Delivery System Preparation.
- While introducing the delivery system into the vessel, do not induce negative pressure on the delivery system. This may cause dislodgement of the stent graft from the balloon.
- Use guiding catheters which have lumen sizes that are suitable to accommodate the stent graft delivery system (See section 10.1 of the GRAFTMASTER™ RX IFU – Materials Required or product label).
Stent Graft Implantation - Precautions
- Pre-dilatations of the vessel must take into account proximal atherosclerotic plaque beyond the treatment area, which may prevent advancement of the device to the treatment area. Failure to do so may increase the difficulty of stent graft placement and cause procedural complications.
- Implanting a stent graft may lead to dissection of the vessel distal and / or proximal to the stent graft, and may cause closure of the vessel, requiring additional intervention (e.g., coronary artery bypass surgery, further dilatation, placement of additional stents, etc.).
- 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.
- Do not exceed the rated burst pressure (RBP) as indicated on the product label. Monitor balloon pressures during inflation. Use of pressures higher than specified on the product label may result in a ruptured balloon with possible intimal damage and dissection.
- An unexpanded stent graft may be retracted into the guiding catheter one time only. An unexpanded stent graft should not be reintroduced into the artery once it has been pulled back into the guiding catheter. Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent graft may be damaged when retracting the undeployed stent graft back into the guiding catheter.
- Stent graft retrieval methods (use of additional wires, snares, and / or forceps) may result in additional trauma to the vasculature and / or the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.
Stent Graft/System Removal – Precautions
Removal of the delivery System Prior to Stent Graft Deployment:
- If removal of the stent graft system is required prior to deployment, ensure that the guiding catheter is coaxially positioned relative to the stent graft delivery system, and cautiously withdraw the stent graft delivery system into the guiding catheter.
- 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.
Withdrawal of the Stent Graft Delivery System from the Deployed Stent Graft
- Deflate the balloon by pulling negative on the inflation device. Confirm balloon deflation under fluoroscopy and wait 10 – 15 seconds longer.
- Position the inflation device to “negative” or “neutral” pressure.
- Stabilize guide catheter position just outside coronary ostium and anchor in place. Maintain guide wire placement across the stent graft segment.
- Gently remove the stent graft delivery system with slow and steady pressure.
- Tighten the rotating hemostatic valve.
Note: If, during withdrawal of the catheter, resistance is encountered, use the following steps to improve balloon rewrap: