FDA Adverse Event
Injury
Summary report: N
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
MDR report key: 3935505
·
Received June 23, 2014
Report
- Report Number
- 9680654-2014-00013
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 19, 2014
- Manufacturer
- WILLIAM COOK AUSTRALIA
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- 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 ((B)(4)) LEAKED THROUGHOUT THE ENTIRE CASE (REPORTED SEPARATELY - SEE 9680654 2014 00012). THIS ALSO OCCURRED WHEN THE DISTAL COMPONENT WAS DEPLOYED (ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BODY). 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 |
|---|---|---|---|---|---|---|---|
| 366812 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY | NONE | MIH | WILLIAM COOK AUSTRALIA | AC935758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other| R |