FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 1201453
·
Received October 16, 2008
Report
- Report Number
- 2017233-2008-00748
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- April 18, 2007
- Report Date
- October 16, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH @ 2017233-2007-00403 WAS SUBMITTED FOR THE GORE PROPATEN VASCULAR GRAFT. THE DEVICE REMAINS IMPLANTED. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL.
Description of Event or Problem · 1
APPROXIMATELY 19 DAYS POST IMPLANTATION OF A VIABAHN DEVICE FOR TREATMENT OF A PSEUDOANEURYSM OF A PRE-EXISTING GORE PROPATEN VASCULAR GRAFT, THE PATIENT PRESENTED WITH INTRA-STENT STENOSIS. A PTA PROCEDURE WAS PERFORMED. THE DEVICE REMAINS IMPLANTED. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY MADE BY THE PHYSICIAN. THIS EVENT IS PART OF A DATA COLLECTION STUDY PERFORMED BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE VIABAHN ENDOPROSTHESIS | NONE | NIP | W.L. GORE & ASSOCIATES,INC | WLG335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |