FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3231956
·
Received July 3, 2013
Report
- Report Number
- 2017233-2013-00436
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 18, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- 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
ATTEMPTS TO ACQUIRE INFO REQUIRED FOR THIS FORM WERE MADE BY GORE.
Description of Event or Problem · 1
IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: NAKAI M, SATO M, SATO H, SAKAGUCHI H, ET AL. MIDTERM RESULTS OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. COMPARISON OF INSTRUCTION-FOR-USE (IFU) CASES AND NON-IFU CASES. JAPANESE JOURNAL OF RADIOLOGY. OF 124 PTS (104 MEN, 20 WOMEN; MEAN AGE OF PTS WITH EXCLUDER IS 77 YEARS; AGE RANGE 58-93 YEARS) WITH AAA WHO UNDERWENT EVAR WITH THE ZENITH (68 PTS) OR EXCLUDER DEVICE (56) AND WERE ANALYZED, 86 WERE IFU AND 38 NON-IFU. THIS ARTICLE MENTIONS THAT 1 PT SUFFERED POST EVAR RENAL INSUFFICIENCY AND WAS TREATED WITH PERMANENT RENAL DIALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304891 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH/ SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES,INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R |