FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN® ENDOPROSTHESIS
MDR report key: 3882211
·
Received June 18, 2014
Report
- Report Number
- 2017233-2014-00324
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 22, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: GORE® VIABAHN® ENDOPROSTHESIS, DEVICE LOT #12113712, MFR REPORT #2017233-2014-00325. REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2014, AN ABDOMINAL AORTIC ANEURYSM PROCEDURE WAS PERFORMED. A CHIMNEY TECHNIQUE WAS USED AND TWO GORE® VIABAHN® ENDOPROSTHESES WERE IMPLANTED IN THE PATIENT¿S ANEURYSMAL RENAL ARTERIES. ON (B)(6) 2014, THE PATIENT PRESENTED WITH RENAL INSUFFICIENCY AND THE GORE® VIABAHN® ENDOPROSTHESES WERE EXPLANTED TO SAVE THE RENAL ARTERIES. THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358668 | GORE VIABAHN® ENDOPROSTHESIS | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES | 12113713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |