FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN® ENDOPROSTHESIS
MDR report key: 4092497
·
Received September 16, 2014
Report
- Report Number
- 2017233-2014-00474
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- July 28, 2014
- Report Date
- August 21, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. REFER TO MEDWATCH #2017233-2014-00475 FOR OTHER DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED TO GORE THE PATIENT PRESENTED 12 DAYS POST IMPLANT, OF THE GORE VIABAHN® ENDOPROSTHESIS, WITH THROMBOSIS. THE PATIENT WAS LYSED OVERNIGHT AND THE THROMBOSIS WAS REMOVED INTERVENTIONALLY THE FOLLOWING DAY. THE DEVICE REMAINS IN THE PATIENT AND IS FUNCTIONING AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573383 | GORE VIABAHN® ENDOPROSTHESIS | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES | 12458218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |