FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2851196
·
Received November 26, 2012
Report
- Report Number
- 2017233-2012-00780
- Event Type
- Injury
- Date Received
- November 26, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 1, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT HIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: PXA320400/8600195, PXC231400/9855112 AND PXC231000/10306040.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL WITH A DISTENDED BELLY. IMAGING REVEALED THE PATIENT HAD AN ABDOMINAL AORTIC ANEURYSM OF 11 CM. THE PATIENT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES. A PROXIMAL TYPE I ENDOLEAK PERSISTED AND THE PHYSICIAN CHOSE TO DO AN OPEN PROCEDURE. THE ENDOGRAFT SYSTEM WAS EXPLANTED AND DISCARDED AT THE FACILITY. 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 | 8065784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Hospitalization| R |