MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-23 for GORE VIABAHN? ENDOPROSTHESIS - 3 VBCR060202A manufactured by W.l. Gore & Associates.
[176079919]
Review of the manufacturing records verified that the lot met release requirements. The device was not returned. Consequently, a direct product analysis was not possible. The gore viabahn? Endoprosthesis instructions for use, warnings section state the following: do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system.
Patient Sequence No: 1, Text Type: N, H10
[176079920]
The following was reported to gore: the patient presented for aortic aneurysm repair. The doctor cut the viabahn and sewed a little section onto the exterior of the cook zenith? Fenestrated aaa endovascular graft on the back table. The doctor reported to gore that there was difficulty in accessing the renal artery with the fenestration. The procedure lasted approximately 12 hours. The doctor reported the patient died as a result of heart issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00050 |
| MDR Report Key | 9622705 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-23 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-06 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2020-01-23 |
| 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 | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABAHN? ENDOPROSTHESIS - 3 |
| Generic Name | NIP |
| Product Code | PFV |
| Date Received | 2020-01-23 |
| Model Number | VBCR060202A |
| Catalog Number | VBCR060202A |
| Lot Number | 21367018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-23 |