FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2012541
·
Received February 28, 2011
Report
- Report Number
- 2017233-2011-00090
- Event Type
- Injury
- Date Received
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K093934
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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
A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN AV ACCESS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE PT'S RIGHT ARM ACROSS THE ELBOW, FROM AN EXISTING GORE-TEX GRAFT AT THE BRACHIAL ARTERY TO THE BRACHIAL VEIN. FIFTEEN DAYS POST IMPLANT, AN OPEN THROMBECTOMY WAS DONE ON THE GORE HYBRID VASCULAR GRAFT. THE GORE HYBRID VASCULAR GRAFT HAD BEEN CANNULATED.
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 | 8272746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |