FDA Adverse Event
Death
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1720177
·
Received June 3, 2010
Report
- Report Number
- 2953161-2010-00102
- Event Type
- Death
- Date Received
- June 3, 2010
- Date of Event
- March 31, 2010
- Report Date
- June 2, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B) (6), 2010, THE PT PRESENTED WITH AN INFECTED RUPTURED AORTIC ANEURYSM. DUE TO THE SMALL DIAMETER OF THE PT'S AORTA ONLY AN AORTIC EXTENDER COMPONENT AND AN ILIAC EXTENDER COMPONENT WERE USED TO SEAL THE RUPTURE. THE PT TOLERATED THE PROCEDURE. AT THE END OF (B) (6) (DATE UNK) THE PT EXPERIENCED HEMATEMESIS ALONG WITH A DUODENAL ULCER. THE FOLLOWING DAY THE PT DIED DUE TO CONTINUED HEMATEMESIS. THE CAUSE OF THE HEMATEMESIS WAS DIAGNOSED AS AN AORTIC FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | WLG325 | 7277209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death |