FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 1241613
·
Received November 21, 2008
Report
- Report Number
- 1820334-2008-00671
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 29, 2008
- Report Date
- October 29, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A PT WITH ANATOMICAL FORM THAT WAS CONSIDERED SUITABLE FOR ENDOVASCULAR REPAIR ALTHOUGH A TORTUOUS LEFT COMMON ILIAC ARTERY AT ABOUT 90 DEGREES, UNDERWENT AAA REPAIR IN 2008. THE LEFT FEMORAL APPROACH WAS PLANNED AT FIRST BUT THE MAIN BODY WAS UNABLE TO BE ADVANCED OVER THE TORTUOUS AREA OF THE LEFT COMMON ILIAC ARTERY, SO IT WAS CHANGED TO THE RIGHT APPROACH. PERFORMANCE OF THE FINAL ANGIOGRAM NOTED A KINK IN THE CONTRALATERAL (LEFT) ILIAC LEG GRAFT. ANOTHER MFR'S BALLOON EXPANDABLE STENT WAS PLACED AT THE SITE TO SUCCESSFULLY RESOLVE THE KING. THE PHYSICIAN COMMENTED THAT THIS EVENT WAS DUE TO PT ANATOMY. THE PT HAS RECOVERED.
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 | F2143984 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |