FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK RX VISION CORONARY STENT SYSTEM
MDR report key: 1203240
·
Received October 10, 2008
Report
- Report Number
- 2024168-2008-00942
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- August 30, 2008
- Report Date
- September 13, 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 Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT STENT FELL OFF OF THE STENT DELIVERY SYSTEM (SDS) BEFORE USE. THIS WAS NOTICED PRIOR TO THE DEVICE ENTERING THE SHEATH. 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 | 8021331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |