FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1130446
·
Received August 19, 2008
Report
- Report Number
- 2017233-2008-00475
- Event Type
- Injury
- Date Received
- August 19, 2008
- Date of Event
- July 11, 2008
- Report Date
- August 19, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE PHYSICIAN CHOSE TO INTENTIONALLY COVER THE LEFT SUBCLAVIAN ARTERY.
Description of Event or Problem · 1
AS REPORTED, IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE TAG THORACIC ENDOPROSTHESIS. THE PHYSICIAN CHOSE TO INTENTIONALLY COVER THE LEFT SUBCLAVIAN ARTERY. POST-OPERATIVELY, THE PATIENT DEVELOPED SUBCLAVIAN STEAL SYNDROME. A REINTERVENTION TOOK PLACE TWO MONTHS LATER, AND A LEFT CAROTID TO LEFT SUBCLAVIAN ARTERY BYPASS WAS PERFORMED. THE PATIENT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES | WLG326 | 05763585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |