FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2200772
·
Received July 28, 2011
Report
- Report Number
- 2017233-2011-00378
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- June 25, 2011
- Report Date
- July 27, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K093934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORD. DEVICE MET RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE THE PT REC'D A GORE HYBRID VASCULAR GRAFT IN THE UPPER ARM FOR AV APPLICATION ON (B)(6) 2011. THE PT RETURNED TO THE OPERATING ROOM (B)(6) 2011 DUE TO ARTERIAL STEAL. THE 6MM DIAMETER ANASTOMOSIS WAS REDUCED DOWN TO 4MM WITH GOOD RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE HYBRID VASCULAR GRAFT | DSY / PROSTHESIS, VASCULAR GRAFT | DSY | W.L. GORE & ASSOCIATES | WLG417 | 9202094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |