FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2232624
·
Received August 25, 2011
Report
- Report Number
- 2017233-2011-00440
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- April 28, 2011
- Report Date
- August 24, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. RESULTS - THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS.
Description of Event or Problem · 1
ON (B)(6), 2010, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2011, THE PT UNDERWENT ANOTHER PROCEDURE TO ADDRESS DISTAL TRUNK MIGRATION AND THE RESULTING TYPE I ENDOLEAK. THE ENDOLEAK RESOLVED WITH PLACEMENT OF AN AORTIC EXTENDER.
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,INC | WLG425 | 7105621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | METFORMIN| LIPITOR| ASPIRIN| GEMFIBROZIL| AORTIC VALVE REPLACEMENT| CORONARY ARTERY BYPASS GRAFT| LISINOPRIL| METOPROLOL| KNEE REPLACEMENT |