FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK RX VISION CORONARY STENT SYSTEM
MDR report key: 1063813
·
Received June 19, 2008
Report
- Report Number
- 2024168-2008-00494
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 22, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- PO20047
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: DISLODGED STENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT AS THE VISION WAS BEING PREPPED, THE STENT WAS OBSERVED TO BE MISSING. IT WAS FOUND ON THE BACK TABLE. THERE WAS NO PT INVOLVEMENT. NO ADD'L EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK RX VISION CORONARY STENT SYSTEM | 74MAF | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8010931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |