FDA Adverse Event
Injury
Summary report: N
MULTI LINK MINI VISION/ CORONARY STENT SYSTEM
MDR report key: 973651
·
Received December 28, 2007
Report
- Report Number
- MW5004833
- Event Type
- Injury
- Date Received
- December 28, 2007
- Date of Event
- December 27, 2007
- Report Date
- December 28, 2007
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MAF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING CASE, DR ATTEMPTED TO CROSS A LESION WITH THE 2.25X12 MINI VISION UNSUCCESSFUL AND REMOVED THE STENT FROM THE PT'S BODY INTACT. STENT WAS VISUALIZED AND FOUND TO BE FRAYED AT THE END. DID SUCCESSFULLY PLACE A MINIVISION 2.25X8. IN 2007 01:42 PM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI LINK MINI VISION/ CORONARY STENT SYSTEM | CARDIOVASCULAR PRODUCTS | MAF | ABBOTT VASCULAR | 7090731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |