FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 4232601
·
Received September 11, 2014
Report
- Report Number
- 1820334-2014-00421
- Event Type
- Malfunction
- Date Received
- September 11, 2014
- Date of Event
- December 4, 2013
- Report Date
- August 12, 2014
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PATIENT UNDERWENT EVAR ON (B)(6) 2013. THE PHYSICIAN PLACED A ZENITH FLEX MAIN BODY STENT GRAFT AND THREE ZENITH ILIAC LEG STENT GRAFTS WITH SPIRAL-Z TECHNOLOGY. SINCE THE IMPLANTATION, THE PATIENT HAS HAD ITCHING. THE PHYSICIAN THINKS THE PATIENT SEEMS TO BE ALLERGIC TO ONE OF THE MATERIALS THE STENTS ARE MADE OF. IF IT IS DETERMINED THAT THE PATIENT IS ALLERGIC TO ONE OF THE MATERIALS, IT IS EXPECTED THAT THE GRAFTS WILL BE EXPLANTED. 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 |
|---|---|---|---|---|---|---|---|
| 563258 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 4448650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ZSLE-20-90-ZT| ZSLE-20-74-ZT| ZSLE-20-90-ZT |