FDA Adverse Event
Death
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1231570
·
Received November 14, 2008
Report
- Report Number
- 2017233-2008-00874
- Event Type
- Death
- Date Received
- November 14, 2008
- Date of Event
- October 15, 2008
- Report Date
- November 14, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS IS BEING CONDUCTED. ADDITIONAL DEVICE: PXL161207/05890068.
Description of Event or Problem · 1
IN 2008, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE WENT AS PLANNED, BUT THE PATIENT EXPIRED WITHIN A DAY DUE TO INTESTINAL ISCHEMIA. THE PHYSICIAN ATTRIBUTED THIS TO A THROMBIC EMBOLISM FROM DEVICE CATHETER MANIPULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG325 | 06210896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |