FDA Adverse Event
Injury
Summary report: N
ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
MDR report key: 2954221
·
Received February 5, 2013
Report
- Report Number
- 1820334-2013-00076
- Event Type
- Injury
- Date Received
- February 5, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - TOP CAP REMOVAL DIFFICULTIES ARE ADDRESSED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE WITH PRIOR OPEN AAA REPAIR UNDERWENT EVAR WITH A ZENITH CONVERTER GRAFT ON (B)(6) 2013. THE PHYSICIAN PASSED THE DEVICE, UNABLE TO PASS GRAY POSITIONER BACK UP THROUGH THE LIMB. TOP CAP CAUGHT THE INTERNAL STENT. PHYSICIAN FELT THIS DIFFICULTY COULD HAVE POSSIBLY BEEN ANATOMICAL, DUE TO THE PRIOR OPEN AAA REPAIR. THE DEVICE WAS UNABLE TO BE REMOVED, THEREFORE, THE PATIENT WAS CONVERTED TO OPEN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS IN STABLE CONDITION UPON THE REPORTER'S EXIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47413 | ZENITH RENU AAA ANCILLARY GRAFT CONVERTER | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 3640602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |