FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1841130
·
Received September 17, 2010
Report
- Report Number
- 2953161-2010-00169
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 16, 2010
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.
Description of Event or Problem · 1
ON (B)(6) 2010, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AN ANGIOGRAM REVEALED THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD UNINTENTIONALLY COVERED THE LEFT HYPOGASTRIC ARTERY. THE PHYSICIAN CHOSE TO LEAVE THE HYPOGASTRIC ARTERY COVERED. THE PT TOLERATED THE SURGERY AND IS STABLE WITH NO FURTHER COMPLICATIONS.
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 | 06353747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| S |