FDA Adverse Event
Death
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3000964
·
Received March 6, 2013
Report
- Report Number
- 2017233-2013-00114
- Event Type
- Death
- Date Received
- March 6, 2013
- Date of Event
- August 9, 2012
- Report Date
- February 19, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2012, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. GORE VIABAHN DEVICES WERE USED TO STENT THE CELIAC, SMA AND RIGHT AND LEFT RENAL ARTERIES. ON (B)(6) 2012, THIS PT PRESENTED WITH A HEMODYNAMIC INSTABILITY AND A CTA SHOWED A RENAL HEMATOMA. ON (B)(6) 2012, DESPITE CLINICAL TREATMENT WITH VASOACTIVE AMINES, THIS PT EVOLVED TO RENAL FAILURE. THE PT SUBSEQUENTLY EVOLVED TO MULTIPLE SYSTEM ORGAN FAILURE AND EXPIRED. THE PHYSICIAN COULD NOT CONFIRM THE EXACT CAUSE OF THE HEMATOMA; HOWEVER, HE BELIEVES IT MAY BE ATTRIBUTED TO THE USE OF HEPARIN OR A COAGULATION DISORDER. ACCORDING TO CT SCAN, THE LEFT KIDNEY WAS W/O ANY SIGN OF STRUCTURAL AND/OR ARTERIAL INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95630 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 10113219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death | PXC201000/10231661| PXC121400/10025325| PXC201200/10304244| PXC121200/10114686 |