BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1345575 · Received March 17, 2009

    Report

    Report Number
    2024168-2009-00442
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 20, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITH BLOOD ON THE SHAFT, BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS DRIED CONTRAST ON THE SHAFT AND CONTRAST IN THE INFLATION LUMEN. THE STENT IMPLANT HAD DISLODGED FROM THE BALLOON AND WAS LOCATED IN A SNARE DEVICE. THE ENTIRE LENGTH OF THE STENT IMPLANT WAS MANGLED AND STRETCHED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WERE TWO KINKS IN THE HYPOTUBE 17.4 CM AND 56 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THERE WERE NO KINKS NOTED TO THE INNER MEMBER OR TIP. A SNARE DEVICE WAS RETURNED INSERTED THROUGH A CO-PILOT. THERE WAS NO DAMAGE NOTED TO THE CO-PILOT. THE PROXIMAL SHAFT OF THE SNARE DEVICE WAS BUNCHED AND TWISTED FOR A LENGTH OF 6 MM DISTAL TO THE PROXIMAL END OF THE DEVICE. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE STENT IMPLANT BEING MANGLED AND STRETCHED. PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISLODGEMENT REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE RX VISION STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS THE RIGHT CORONARY ARTERY (RCA) LESION. UPON REMOVAL OF THE SDS, AS IT WAS PULLED BACK INTO THE GUIDING CATHETER, THE STENT DISLODGED. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED FROM THE PT'S ANATOMY WITH A SNARE DEVICE. NO ADDITIONAL EVENT OR PT INFO WAS 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 8112641

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention GUIDE WIRE: BMW GUIDE WIRE| GUIDE CATH: 6FR HOCKEY STICK GUIDING CATHETER