MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-08-16 for GORE VIABAHN ENDOPROSTHESIS WLG335 VB111002 manufactured by W.l. Gore & Associates,inc.
[525261]
In 2006, physician treated sfa and popliteal vessels. Vessels were aneurismal and calcified. Physician did not pre dilate vessels due to the condition of the aneurysms. Fluoroimaging showed sizing was good. Three 13mm x 10cm viabahn devices were implanted proximal and two 11mm x 10cm viabahn devices (device 1 - lot 04424735 and device 2 - lot 04462331) were implanted distal. Distal device landing site was 3 cm. One of the 11mm x 10cm devices continually invaginated in the popliteal artery when patient's knee bent. Invagination occurred in the middle portion of device. Unable to tell which 11mm x 10cm lot was suspect. Physician removed all devices and left small portions of distal 11mm x 10cm device & proximal 13mm x 10cm device for creation of anastomosis with unknown type of ptfe graft. Patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[7794269]
Device was discarded and could not be evaluated. A review of the manufacturing paperwork was conducted. The review of the manufacturing records verified that the lot met all pre-released specification. Add'l lot # 04462331, expiration date: 05/31/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017233-2006-00212 |
| MDR Report Key | 752139 |
| Report Source | 05,07 |
| Date Received | 2006-08-16 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-07-24 |
| Date Facility Aware | 2006-07-24 |
| Report Date | 2006-08-15 |
| Date Mfgr Received | 2006-07-24 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2006-08-21 |
| 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 | MARK RIMBERGAS |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86001 |
| Manufacturer Country | US |
| Manufacturer Postal | 86001 |
| Manufacturer Phone | 9288644158 |
| Manufacturer G1 | W.L. GORE & ASSOCIATES, INC. |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABAHN ENDOPROSTHESIS |
| Generic Name | ENDOVASCULAR GRAFT SYSTEM |
| Product Code | NIH |
| Date Received | 2006-08-16 |
| Model Number | WLG335 |
| Catalog Number | VB111002 |
| Lot Number | 04424735 |
| ID Number | DEVICE 1 |
| Device Expiration Date | 2009-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 739921 |
| Manufacturer | W.L. GORE & ASSOCIATES,INC |
| Manufacturer Address | * FLAGSTAFF AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-16 |