MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1996-10-23 for THIN WALLD GORE-TEX VASCULAR GRAFT UNK manufactured by W.l. Gore & Associates, Inc..
[30894]
The prosthesis was implanted aftr a previous dialysis shunt failed because of infection. Three mos. P. O. , prosthesis thrombosed necessitating embolectomy. Following embolectomy, swelling occurred resulting in a cyst. At four mos. P. O. , revision revealed serous fluid leaking through graft wall at arterial end. The leaking segment was removed and replaced with another prosthetic material.
Patient Sequence No: 1, Text Type: D, B5
[7760341]
Tha sample consists of one segment of 6mm thin walled vascular graft, measuring approx 4 cm in length. A slightly beveled anastomatic end is noted although no sutures are visible. The apposite end is squarely cut. Thin reddish brown clot covers a portion of the longitudinal aspect of the graft outer surface. Small nodules of firmly adherent fibrous materials are noted within 1. 5 cm of the anastomosis. Much of the remainder of the graft outer surface appears free of tisue and thrombus. The graft wall is uniformly light brown. Thin, soft, reddish-brwon thombus lines most of the luminal surface. Two longitudinal sections are submitted for histological evaluation. Section 9-2396-1a is a loongitudinal section at the anastomaotic end. Section 9-2396-1b is a longitudinal section to include portions of lthe graft wall that are devoid of tissue or thrombus. Histological observations are consistent with localized transmural serous fluid ultrafiltration as well as areas of early healing in a graft of relatively short implant duration. The findings are also consistent with relatively poor healing for an implant duration of four months. As portions of the graft wall may have contributed to the serous fluid ultrafiltration in those regions. (*0
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025240-1996-00007 |
| MDR Report Key | 44912 |
| Report Source | 01,05,07 |
| Date Received | 1996-10-23 |
| Date of Report | 1996-10-23 |
| Date of Event | 1996-08-09 |
| Date Reported to Mfgr | 1996-09-23 |
| Date Mfgr Received | 1996-09-23 |
| Date Added to Maude | 1996-10-30 |
| 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 | THIN WALLD GORE-TEX VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR PROSTHESIS |
| Product Code | MCI |
| Date Received | 1996-10-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 45819 |
| Manufacturer | W.L. GORE & ASSOCIATES, INC. |
| Manufacturer Address | 3450 W KILTIE LANE FLAGSTAFF AZ 860020500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-23 |