FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1873048
·
Received October 14, 2010
Report
- Report Number
- 2953161-2010-00186
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 16, 2010
- Report Date
- October 13, 2010
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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
IN (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS IN A 20 MM AORTA. ON (B)(6), 2010, IT WAS REPORTED TO GORE THAT THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL COMPONENT WAS OCCLUDED DUE TO THE LIMB BEING COMPRESSED BY RADIAL FORCE OF THE OVERLAP BETWEEN THE CONTRALATERAL LEG COMPONENT AND THE TRUNK-IPSILATERAL LEG COMPONENT WHICH WAS FIXED WITH AN EXPRESS BOSTON 37MM X 10MM STENT. THE PATIENT IS REPORTED TO BE DOING WELL.
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 | 8023287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |