FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2211293
·
Received August 3, 2011
Report
- Report Number
- 2017233-2011-00393
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- March 24, 2011
- Report Date
- August 2, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K093934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE MFG RECORD HISTORY. REVIEW OF THE DEVICE MFG RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN AV ACCESS APPLICATION. THE PROCEDURE WAS DONE IN THE PT'S UPPER ARM, FROM THE AXILLARY ARTERY TO THE AXILLARY VEIN. ON (B)(6) 2011, THE GRAFT WAS LIGATED DUE TO MONOMELIC MEDIAN NERVE NEUROPATHY.
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 | 8428277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |