MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-02-09 for GORE-TEX VASCULAR GRAFT WLG211 V47030L manufactured by W.l. Gore & Associates.
[18330063]
Within a few days following implant of the graft for dialysis access, swelling was observed. The physician suspected a peri-graft hematoma. Exploratory surgery revealed that the graft was weeping fluid. The physician placed dermabond on the graft; however, it did not seal the graft. Thus, three months post-operatively, the physician explanted the graft and implanted a bovine graft. The affected graft was returned for examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2006-00016 |
| MDR Report Key | 673663 |
| Report Source | 07 |
| Date Received | 2006-02-09 |
| Date of Report | 2006-02-08 |
| Date of Event | 2006-01-19 |
| Date Facility Aware | 2006-01-19 |
| Date Mfgr Received | 2006-01-19 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-02-14 |
| 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 | MONIKA ZAFFUTO |
| Manufacturer Street | 1500 N. FOURTH ST |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | W.L. GORE & ASSOCIATES |
| Manufacturer Street | 1505 N. 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 | EPTFE VASCULAR PROSTHESIS |
| Product Code | MCI |
| Date Received | 2006-02-09 |
| Model Number | WLG211 |
| Catalog Number | V47030L |
| Lot Number | 03694028 |
| ID Number | NA |
| Device Expiration Date | 2010-04-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 662974 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | 1505 NORTH FOURTH ST. FLAGSTAFF AZ 86004 US |
| Baseline Brand Name | THINWALLED GORE-TEX STRETCH VASCGRAFT CONFIG FOR PEDIA.SHUNT |
| Baseline Generic Name | EPTFE VASCULAR PROSTHESIS |
| Baseline Model No | WLG211 |
| Baseline Catalog No | ST05010 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-09 |