FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 2111106
·
Received May 25, 2011
Report
- Report Number
- 1820334-2011-00249
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 25, 2011
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NO PATIENT INJURY REPORTED. (B)(4): ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT UNDERWENT AAA AND RIGHT COMMON ILIAC ARTERY ANEURYSM REPAIR UNDER GENERAL ANESTHESIA ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. FINAL ANGIOGRAPHY REVEALED AN ENDOLEAK THOUGHT TO BE A DISTAL TYPE I OR A TYPE IV. AFTER ADDITIONAL BALLOONING, THE PHYSICIAN CONSIDERED THE ENDOLEAK AS A TYPE IV AND DECIDED TO TAKE FOLLOW-UP OBSERVATION. ACT 15 MINUTES BEFORE THE PROCEDURE WAS COMPLETED WAS 295. NO ADVERSE EFFECT TO THE PATIENT WAS OBSERVED AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | F2580205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |