FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 3973254
·
Received June 6, 2014
Report
- Report Number
- 1820334-2014-00249
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 14, 2014
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A PATIENT UNDERWENT EVAR ON (B)(6) 2014. THERE WAS EXTREME VALVE LEAKAGE OF THE SHEATH OF THE MAIN BODY DEVICE. ACTION TAKEN: FAST WORKING TO PREVENT MORE BLOOD LOSS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331496 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH | COOK, INC. | NA | 4875065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |