FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 2170723
·
Received June 22, 2011
Report
- Report Number
- 1820334-2011-00308
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 23, 2011
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DIFFICULTY PLACING DUE TO DIFFICULTY SEEING GOLD MARKERS IS NOT SPECIFICALLY ADDRESSED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
MARKERS ON THE DEVICE APPEARED IN AN UNUSUAL MANNER AND DID NOT CLEARLY DEFINE LIMIT OF COVERED STENT (1820334-2011-00308). THIS MADE POSITIONING THE DEVICE DIFFICULT AND CREATED CONCERN ABOUT COVERING THE RENAL ARTERY. ALSO, WITH THE SAME DEVICE, THE CAPTOR VALVE LEAKED LARGE AMOUNTS OF BLOOD, EVEN IN THE CLOSED POSITION (1820334-2011-00309). NO HARM TO THE PT REPORTED. PROCEDURE WAS COMPLETED AND DEVICE REMAINS IN SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURSYM TREATMENT | MIH | COOK, INC. | NA | 2696871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |