MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-04 for GORE-TEX VASCUALR GRAFT UNK V47040L manufactured by W.l. Gore & Associates.
[15606556]
Graft implanted as forearm shunt for dialysis access approx 4 1/2 yrs ago. A ruptured pseudoaneurysm rendered the shunt non-functional, necessitating removal. According to health care professional, this was an unexpected end-of-life for the shunt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025240-1996-00005 |
| MDR Report Key | 41339 |
| Date Received | 1996-10-04 |
| Date of Report | 1996-10-03 |
| Date of Event | 1996-08-19 |
| Date Facility Aware | 1996-08-19 |
| Date Mfgr Received | 1996-09-04 |
| Date Added to Maude | 1996-10-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX VASCUALR GRAFT |
| Generic Name | EPTFE VASCULAR PROSTHESIS |
| Product Code | MCI |
| Date Received | 1996-10-04 |
| Returned To Mfg | 1996-09-04 |
| Model Number | UNK |
| Catalog Number | V47040L |
| Lot Number | 33464 |
| ID Number | UNK |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 42418 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | MEDICAL PRODUCTS DIVISION PO BOX 500 FLAGSTAFF AZ 860020500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-04 |