MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-20 for GORE TEX VASCULAR GRAFT (LINED) WLG200 V06030L manufactured by W.l. Gore & Associates,inc.
[17061714]
Via a medwatch 3500a report, a pt presented with fever, chills and clinical signs of a small abscess overlying a gore tex vascular graft (lined) a-v access graft. While undergoing dialysis in preparation for an operation, the graft ruptured from an area which had developed a false aneurysm from multiple needle punctures. There was substantial hemorrhage and the pt underwent emergent surgery. The graft was completely explanted and discarded and hemostatisis was obtained. The pt was dishcharged home in 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020164 |
| MDR Report Key | 1020164 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-02-27 |
| Date Added to Maude | 2008-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE TEX VASCULAR GRAFT (LINED) |
| Generic Name | EPTFE VASCULAR PROSTHESIS |
| Product Code | FIQ |
| Date Received | 2008-03-20 |
| Model Number | WLG200 |
| Catalog Number | V06030L |
| Lot Number | 05020913 |
| ID Number | * |
| Device Expiration Date | 2012-04-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 987301 |
| Manufacturer | W.L. GORE & ASSOCIATES,INC |
| Manufacturer Address | 1505 NORTH FOURTH ST. FLAGSTAFF AZ 86004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2008-03-20 |