FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN ENDOPROSTHESIS
MDR report key: 1201446
·
Received October 16, 2008
Report
- Report Number
- 2017233-2008-00747
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- January 3, 2008
- Report Date
- October 16, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- 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
THE DEVICE REMAINS IMPLANTED. ATTEMPTS TO OBTAIN FURTHER INFO REGARDING THIS EVENT WERE UNSUCCESSFUL.
Description of Event or Problem · 1
APPROX 20 DAYS FOLLOWING IMPLANTATION OF A VIABAHN DEVICE FOR TREATMENT OF OUTFLOW STENOSIS OF A PRE-EXISTING GORE PROPATEN VASCULAR GRAFT, THE PT PRESENTED WITH THROMBOSIS WITH STENOSIS. A THROMBECTOMY AND PTA PROCEDURE WERE PERFORMED. THE PT WAS FINE AT THE END OF THE PROCEDURE. 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 | WLG335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |