FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 886888
·
Received July 26, 2007
Report
- Report Number
- 2024168-2007-00296
- Event Type
- Malfunction
- Date Received
- July 26, 2007
- Date of Event
- June 29, 2007
- Report Date
- June 29, 2007
- 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECOND MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM, PART # 1007821-08, LOT # 5092831.
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 2.25X8MM MINIVISION STENT DISLODGED FROM THE BALLOON WHEN THE SHEATH WAS REMOVED. THEN WHEN THE 2.0X8MM MINIVISION WAS BEING ADVANCED, WHILE STILL IN THE GUIDING CATHETER, IT WAS OBSERVED THAT THERE WAS NO STENT ON THE BALLOON. THE DEVICE WAS REMOVED AND THE STENT IMPLANT WAS FOUND ON THE TABLE. THERE WERE NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 | 7051031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | STENT: 2.0X8MM MULTI-LINK MINIVISION| PART# 1007821-08 |