FDA Adverse Event
Injury
Summary report: N
GORE TEX VASCULAR GRAFT
MDR report key: 1910262
·
Received November 22, 2010
Report
- Report Number
- 2017233-2010-00515
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DYF
- PMA / PMN Number
- K802095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE MANUFACTURING RECORD HISTORY. REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2010, A THIN-WALLED GORE-TEX VASCULAR GRAFT WAS IMPLANTED IN THE PATIENT'S UPPER ARM. ON (B)(6) 2010, THE GRAFT SPLIT IN HALF WHEN THE PATIENT HAD A VIOLENT FALL. THE GRAFT WAS REPAIRED USING AN INTERPOSITION GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TEX VASCULAR GRAFT | DYF / PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER | DYF | W.L. GORE & ASSOCIATES | WLG200 | 06854188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |