FDA Adverse Event
Malfunction
Summary report: N
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
MDR report key: 3962557
·
Received June 27, 2014
Report
- Report Number
- 9680654-2014-00015
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Date of Event
- May 29, 2014
- Report Date
- June 26, 2014
- Manufacturer
- WILLIAM A. COOK AUSTRALIA
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION TO BE PROVIDED ONCE INVESTIGATION COMPLETE.
Description of Event or Problem · 1
A (B)(6) MALE UNDERWENT AN EVAR PROCEDURE. ONCE THE DEVICE WAS ADVANCED INTO THE ABDOMINAL AORTA, THE VALVE BEGAN TO LEAK AT A CONSISTENT RATE. THE PHYSICIAN WAS UNABLE TO STOP THE LEAKAGE. THE PHYSICIAN FELT IT WAS UNWISE TO CONTINUE THE PROCEDURE DUE TO RISK OF BLOOD LOSS AND ABORTED THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375880 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY | NONE | MIH | WILLIAM A. COOK AUSTRALIA | AC935030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |