FDA Adverse Event
Injury
Summary report: N
GORE® EXCLUDER® AAA ENDOPROSTHESIS
MDR report key: 4223781
·
Received November 4, 2014
Report
- Report Number
- 2953161-2014-00122
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- November 7, 2008
- Report Date
- October 22, 2014
- 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
ADDITIONAL MANUFACTURER NARRATIVE- THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2008, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE THE RIGHT INTERNAL ILIAC ARTERY WAS UNINTENTIONAL COVERED WITH THE DEVICE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. LATER, THE PATIENT WAS DISCHARGED. NO FURTHER ISSUE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705673 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 05897319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |