FDA Adverse Event
Malfunction
Summary report: N
GORE EXCLUDER THORACIC ENDOPROSTHESIS
MDR report key: 1082846
·
Received July 25, 2008
Report
- Report Number
- 2017233-2008-00410
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- April 10, 2008
- Report Date
- July 24, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES,INC.
- Product Code
- MIH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.
Description of Event or Problem · 1
AS REPORTED, IN 1999, THIS PT WAS IMPLANTED WITH TWO GORE EXCLUDER THORACIC ENDOPROSTHESIS FOR AN EXPANDING PSEUDOANEURYSM IN THE DESCENDING THORACIC AORTA. SIX MONTHS LATER, THE ANEURISMAL SEGMENT MEASURED 62MM IN DIAMETER. IN 2008, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED THE ANEURYSM HAD DECREASED TO 50MM IN DIAMETER. A FRACTURE IN THE SPINE OF THE GRAFT AND A TYPE III ENDOLEAK WERE ALSO IDENTIFIED. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES,INC. | WLG326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |