FDA Adverse Event
Injury
Summary report: N
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
MDR report key: 3121959
·
Received May 15, 2013
Report
- Report Number
- 9680654-2013-00003
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 1, 2012
- Report Date
- May 15, 2013
- Manufacturer
- WILLIAM COOK AUSTRALIA
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATIONS: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2012. FOUR MONTHS POST-PROCEDURE THE PATIENT WAS ADMITTED WITH BACK PAIN. THE RIGHT RENAL ARTERY HAD INFARCTED. THE CAUSE WAS UNKNOWN, BUT THE SURGEON STATED THAT THE COVERED ICAST STENT (MANUFACTURED BY ATRIUM) MIGHT HAVE BEEN EXCESSIVELY OVERSIZED TO THE DIAMETER OF THE RENAL ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214490 | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY | NONE | MIH | WILLIAM COOK AUSTRALIA | AC912239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening | CODA BALLOON| HIFLEX ANCIL SHEATHS| ROSEN WIRE GUIDES| CHECK-FLO INTRODUCER| GLIDE ADVANTAGE 260 CM WIRE GUIDE| LUNDERQUIST 260 CM WIRE GUIDES |