FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 4202287
·
Received October 17, 2014
Report
- Report Number
- 1820334-2014-00525
- Event Type
- Injury
- Date Received
- October 17, 2014
- Date of Event
- July 30, 2014
- Report Date
- September 19, 2014
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PT UNDERWENT EVAR ON (B)(6) 2014. THE DEVICE WAS TO BE IMPLANTED AND WAS SUCCESSFULLY PLACED. AFTER PUTTING ALL STENTS IN PLACE A VERIFYING ANGIO WAS MADE. THROUGH A HOLE OR TEAR IN THE FABRIC, CONTRAST WAS POURING OUT IN THE ANEURYSM SACK. THE PROXIMAL PART OF THE IPSILATERAL LIMB WAS RELINED WITH AN ADD'L STENT GRAFT. ACCORDING TO THE REPORTER, THERE WAS NO PT INJURY AND THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663016 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 5007612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |