FDA Adverse Event
Malfunction
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 1170302
·
Received September 12, 2008
Report
- Report Number
- 2024168-2008-00801
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 15, 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
- OTHER
Narratives
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 DURING THE INTERVENTION, THE PHYSICIAN TRIED TO INFLATE THE BALLOON, BUT THE BALLOON DID NOT INFLATE. THEN, THE PHYSICIAN SAW IN THE VIDEO THAT THE STENT DISLODGED FROM THE BALLOON. THEN, THE PHYSICIAN REMOVED THE SYSTEM. THE STENT WS REMOVED WITH THE SYSTEM, IT DID NOT STAY INSIDE THE PATIENT. THERE WAS NO RESISTANCE DURING THE INSERTION. 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 | 7121731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | STENT: MINI VISION |