FDA Adverse Event
Death
Summary report: N
ZENITH AAA MAIN BODY GRAFT
MDR report key: 1021955
·
Received March 31, 2008
Report
- Report Number
- 1820334-2008-00219
- Event Type
- Death
- Date Received
- March 31, 2008
- Report Date
- March 6, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH ZENITH DEVICES IMPLANTED IN 2006 WAS ADMITTED EMERGENTLY IN 2008 WITH A RUPTURED AAA. THE PRE-OP CT WAS IN 2008. THE PATIENT WAS ADMITTED DUE TO A RECENT MYOCARDIAL INFARCTION WHEN HIS AAA RUPTURED. THE GRAFTS WERE EXPLANTED. THE PT SURVIVED THE EXPLANT PROCEDURE, BUT EXPIRED A FEW DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA MAIN BODY GRAFT | MIH ENDOVASCULAR GRAFT | MIH | COOK, INC. | NA | 1704002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |