FDA Adverse Event
Malfunction
Summary report: N
GORE HYBRID VASCULAR GRAFT
MDR report key: 2169307
·
Received July 11, 2011
Report
- Report Number
- 2017233-2011-00334
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 13, 2011
- Report Date
- July 8, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K093934
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET COMPLETED.
Description of Event or Problem · 1
ON (B)(6) 2011, A MALE PATIENT WAS BEING IMPLANTED WITH A GORE HYBRID VASCULAR GRAFT IN AN ABOVE-THE-KNEE FEM-POP PROCEDURE. IT WAS REPORTED TO GORE THAT AS THE PHYSICIAN WAS POSITIONING THE NITINOL REINFORCED STENT (NRS) PORTION OF THE GRAFT INTO THE POPLITEAL ARTERY, THE TIP OF THE NRS PORTION OF THE GRAFT UNINTENTIONALLY PARTIALLY DEPLOYED. THE GORE HYBRID VASCULAR GRAFT WAS REMOVED AND RETURNED TO GORE FOR EVALUATION.
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 | 8905100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |