FDA Adverse Event
Injury
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 1060461
·
Received June 13, 2008
Report
- Report Number
- 2024168-2008-00488
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- PO20047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY / MEDICAL INTERVENTION. REPORTING RATIONALE: STENT DISLODGEMENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED DURING USE. IT WAS RETRIEVED WITH A SNARING DEVICE. NO PT EFFECTS WERE REPORTED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM | 74MAF | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8022732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |