FDA Adverse Event
Injury
Summary report: N
GORE VIABAHN® ENDOPROSTHESIS
MDR report key: 4336650
·
Received December 17, 2014
Report
- Report Number
- 2017233-2014-00668
- Event Type
- Injury
- Date Received
- December 17, 2014
- Date of Event
- November 23, 2014
- Report Date
- November 25, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- NIP
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO MANUFACTURER (REMAINS IN PATIENT). THEREFORE, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.
Description of Event or Problem · 1
ON (B)(6) 2014, A PATIENT UNDERWENT A CHIMNEY PROCEDURE WHERE A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN THE MESENTERIC ARTERY SUPERIOR WITH A DIAMETER OF 5.5CM. IT WAS REPORTED THAT THE MEDICAL DEVICE WAS RELEASED TOO DEEP INTO THE VESSEL BASED ON THE POOR DEVICE VISIBILITY. ON (B)(6) 2014, A COMPUTER TOMOGRAPHY WAS PERFORMED WHERE IT WAS OBSERVED THAT THERE WAS NO BLOOD FLOW THROUGH THE MESENTERIC ARTERY SUPERIOR. ON (B)(6) 2014, THE MESENTERIC ARTERY SUPERIOR WAS POST DILATED WITH A BALLOON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828881 | GORE VIABAHN® ENDOPROSTHESIS | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | W.L. GORE & ASSOCIATES | 11069581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS |