FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 3161575
·
Received May 6, 2013
Report
- Report Number
- 2017233-2013-00357
- Event Type
- Injury
- Date Received
- May 6, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 22, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT PRESENTED FOR TREATMENT OF TAA GORE VIABAHN ENDOPROSTHESIS WERE PLACED IN A CHIMNEY AND SNORKELING TECHNIQUE FOR THE TREATMENT OF VISCERAL AND RENAL ARTERIES. FOUR WEEKS POST IMPLANT THE PATIENT PRESENTED WITH PAIN IN THE ABDOMEN. THE PHYSICIAN DISCOVERED A DISFUNCTION OF THE RIGHT KIDNEY. THE PHYSICIAN ELECTED TO IMPLANT TWO SUPERA STENTS INSIDE THE TWO GORE VIABAHN ENDOPROSTHESIS THAT WERE PREVIOUSLY IMPLANTED IN THE RIGHT AND LEFT RENAL ARTERIES. THE RENAL ARTERIES ARE REPORTED TO BE PATENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197742 | GORE VIABAHN ENDOPROSTHESIS | NIP / STENT, SUPERFICIAL FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES | 10707737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |