FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 3945311
·
Received May 7, 2014
Report
- Report Number
- 1820334-2014-00208
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- 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). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE OF THE FLEXER SHEATH (LEAKAGE AMOUNT IS UNKNOWN), SO HE REMOVED IT AND INSERTED ANOTHER 16FR CHECK-FLO SHEATH. (1820334-2014-00208). FINAL ANGIO SHOWED A TYPE LLL ENDOLEAK FROM SUTURE HOLE. HE BALLOONED THE PROXIMAL NECK, DISTAL AND JUNCTIONS AGAIN BUT THE LEAK PERSISTED, SO HE PLACED A MAIN BODY EXTENSION AND THE LEAK WAS RESOLVED. (1822034-2014-00212). THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274946 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 3416387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |