FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR STENT 2.5MM X 30MM
MDR report key: 1083462
·
Received July 28, 2008
Report
- Report Number
- MW5007818
- Event Type
- Malfunction
- Date Received
- July 28, 2008
- Date of Event
- June 12, 2008
- Report Date
- July 28, 2008
- Manufacturer
- MEDTRONIC
- Product Code
- NIQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
STENT PULLED FREE FROM CATHETER. NO CLINICAL SEQUALE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CAD/ANGINA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR STENT 2.5MM X 30MM | NONE | NIQ | MEDTRONIC | 0000679530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |