FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 3063356
·
Received March 28, 2013
Report
- Report Number
- 1820334-2013-00149
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 8, 2013
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE UNDERWENT EVAR ON (B)(6) 2013. THE PHYSICIAN PLACED A FLEX MAIN BODY GRAFT AND TWO SPIRAL Z ILIAC LEG GRAFT. THE PHYSICIAN PERFORMED AN ILIAC ANGIOPLASTY IN BOTH THE LEFT AND RIGHT LEGS AFTER THE PROCEDURE DUE TO EXTERNAL COMPRESSION (FOR BOTH SIDES) ON AN UNK DATE ((B)(6) 2013). EXTERNAL COMPRESSION WAS NOT OBSERVED AT THE CONCLUSION OFF THE PROCEDURE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128939 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR |