FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK RX VISION CORONARY STENT SYSTEM
MDR report key: 1082078
·
Received July 23, 2008
Report
- Report Number
- 2024168-2008-00592
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 22, 2008
- Report Date
- June 23, 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
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PT ANATOMY AND CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE SDS WHEN IT WAS UNPACKED. REPORTEDLY, THERE WAS NO PT INVOLVEMENT. NO ADDITIONAL 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 | 8012931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |