FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2870157
·
Received December 5, 2012
Report
- Report Number
- 2017233-2012-00803
- Event Type
- Injury
- Date Received
- December 5, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K093934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, A GORE HYBRID VASCULAR GRAFT WAS USED IN A A-V ACCESS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE PATIENT'S UPPER ARM. ON (B)(6) 2012, THE GRAFT WAS REMOVED DUE TO AN INFECTION. THE HYBRID GRAFT HAD NOT CANNULATED WHILE THE GRAFT WAS IMPLANTED.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |