FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 2072604
·
Received April 20, 2011
Report
- Report Number
- 1820334-2011-00200
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION: UNKNOWN AS LOT IS UNKNOWN. (B)(4) EXPLANT IS LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE PT UNDERWENT A PROCEDURE TO EXPLANT ZENITH DEVICES ON (B)(6) 2011. THE ORIGINAL DATE OF IMPLANT WAS NOT PROVIDED NOR WERE DEVICES LISTED. THE REASON FOR EXPLANT IS BELIEVED TO HAVE BEEN DUE TO A PINHOLE IN ONE OF THE ZENITH ILIAC LEGS. NO FURTHER INFO IS AVAILABLE. ALL DEVICES WERE EXPLANTED; HOWEVER, PT CURRENT CONDITION WAS NOT PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |