FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2851158
·
Received November 26, 2012
Report
- Report Number
- 2017233-2012-00779
- Event Type
- Injury
- Date Received
- November 26, 2012
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PATIENT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A GORE EXCLUDER AAA ENDOPROSTHESES TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED. THE PHYSICIAN APPLIED MORE FORCE THAN INTENDED AND THE DEVICE LANDED 1 CM PROXIMAL OF THE INTENDED POSITION AND COVERED THE RENALS. THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK DOWN TO THE INTENDED POSITION WITH A CODA BALLOON. THE PROCEDURE WAS COMPLETED AND THE ANEURYSM WAS EXCLUDED. THE PATIENT TOLERATED THE PROCEDURE.
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 | 7351451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R | ASPIRIN| LIPITOR| LASIX| AMIODARONE| METOPROLOL |