MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-13 for GORE-TEX VASCULAR GRAFT WLG250 manufactured by W.l. Gore & Associates, Inc.
[739167]
As reported, the av access pt received a 6mm gore-tex vascular graft in the left arm. Approx 3. 5 yrs post implant, the pt experienced edema at the graft location. The physician explanted the graft and returned the graft for further analysis.
Patient Sequence No: 1, Text Type: D, B5
[7896940]
Implant date is unknown; however, the implant duration was 3. 5 yrs. Device evaluation anticipated, but not yet completed. The investigation is presently in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017233-2007-00373 |
| MDR Report Key | 953263 |
| Report Source | 05 |
| Date Received | 2007-11-13 |
| Date of Report | 2007-11-12 |
| Date Mfgr Received | 2007-10-02 |
| Date Added to Maude | 2008-03-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES SILVER |
| Manufacturer Street | 1505 NORTH FOURTH ST. |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | 9288644353 |
| Manufacturer G1 | W.L. GORE & ASSOCIATES,INC |
| Manufacturer Street | 1505 NORTH FOURTH ST. |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX VASCULAR GRAFT |
| Generic Name | VASCULAR PROSTHESIS |
| Product Code | FIQ |
| Date Received | 2007-11-13 |
| Returned To Mfg | 2007-10-02 |
| Model Number | WLG250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 950354 |
| Manufacturer | W.L. GORE & ASSOCIATES, INC |
| Manufacturer Address | 1505 NORTH FOURTH ST. FLAGSTAFF AZ 86004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-13 |