FDA Adverse Event
Injury
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2200782
·
Received July 29, 2011
Report
- Report Number
- 2017233-2011-00383
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- April 4, 2011
- Report Date
- July 28, 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
METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, A PATIENT WAS IMPLANTED WITH A GORE HYBRID VASCULAR GRAFT IN AN AV ACCESS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE UPPER ARM FROM THE BRACHIAL ARTERY TO THE AXILLARY VEIN. IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, A THROMBECTOMY WITH ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED.
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 | 8428275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |