FDA Adverse Event
Injury
Summary report: N
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
MDR report key: 3935463
·
Received June 23, 2014
Report
- Report Number
- 9680654-2014-00012
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 19, 2014
- Manufacturer
- WILLIAM A. COOK AUSTRALIA
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DELIVERY SYSTEM VALVE ON THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY (ZFEN P-2-30-109-R) LEAKED THROUGHOUT THE ENTIRE CASE. THIS ALSO OCCURRED WHEN THE DISTAL COMPONENT WAS DEPLOYED (ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BODY (ZFEN-D-12-62-76-C -REPORTED SEPARATELY SEE 9680654-2014-00013). THE PATIENT LOST BLOOD. TWO UNITS OF BLOOD WERE TRANSFUSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY DESPITE THE LEAKING DELIVERY SYSTEMS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367017 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY | NONE | MIH | WILLIAM A. COOK AUSTRALIA | AC935759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other| R |