MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for GRAFTMASTER 1012820-19 manufactured by Abbott Vascular.
[182743449]
(b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. It was reported that the procedure was performed to treat a right cavernous carotid fistula. It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use, states: 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 greater than or equal to 2. 75 mm in diameter. In this case, it is unknown if the ifu deviation directly caused or contributed to the event. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The other 4. 5x19 graftmaster device referenced and the 4. 5x26 graftmaster referenced are being filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[182743450]
It was reported that the procedure was performed to treat a right cavernous carotid fistula. A 4. 5x19mm graftmaster covered stent was implanted, but the stent could only be expanded to 3. 5mm diameter instead of 4. 5mm despite dilatation up to rated burst pressure. The fistula was still permeable, so another 4. 5x19mm graftmaster covered stent was implanted to continue to treat the fistula. However, this stent had the same dilatation issue. The fistula was, again, still permeable, so a 4. 5x26mm graftmaster covered stent was implanted to continue to treat the fistula. This stent also had the same dilatation issue, so a coil was used to finish treating the fistula. There was no intervention performed to treat the stents. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02175 |
| MDR Report Key | 9808502 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-09 |
| Catalog Number | 1012820-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |