FDA Adverse Event
Malfunction
Summary report: N
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATE DBODY
MDR report key: 2891023
·
Received December 20, 2012
Report
- Report Number
- 9680654-2012-00003
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 3, 2012
- Manufacturer
- WILLIAM COOK AUSTRALIA
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE DISTAL MAIN BODY OF THE ZENITH FENESTRATED DEVICE WAS BEING DEPLOYED. THE BLACK TRIGGER WIRE (PROXIMAL) WAS VERY DIFFICULT FOR THE SURGEON TO REMOVE. THE DOCTOR TWISTED THE KNOB TO RELIEVE SOME OF THE TENSION WHICH ALLOWED HER TO PULL THE KNOB BACK FREELY. THERE WAS NO APPARENT INJURY TOT HE PT AND THE DEVICE OPERATED AS IT SHOULD FOLLOWING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATE DBODY | NONE | MIH | WILLIAM COOK AUSTRALIA | NA | AC911701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |