FDA Adverse Event
Injury
Summary report: N
PROTEGE EVERFLEX LONG SELF EXPANDING NITINOL STENT
MDR report key: 1241253
·
Received November 11, 2008
Report
- Report Number
- 2183870-2008-00174
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- April 12, 2006
- Report Date
- October 29, 2008
- Manufacturer
- EV3 INC.
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS PROCEDURE WAS PERFORMED IN OTHER COUNTRY: AT 6 MONTHS FOLLOW-UP, IT WAS JUDGED BY THE SITE THAT THERE WERE NO STENT FRACTURES SEEN AT X-RAY IN THE SFA. AN INDEPENDENT EVALUATION WAS PERFORMED AND AN ELONGATION ALONG WITH A TYPE II FRACTURE WAS FOUND. THE PATIENT DIED IN 2007, 7 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH WAS REPORTED AS HEART FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE EVERFLEX LONG SELF EXPANDING NITINOL STENT | FGE | EV3 INC. | PRP35-08-150-120 | 1678553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |