BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1162268 · Received September 5, 2008

    Report

    Report Number
    2024168-2008-00777
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 8, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PATIENT ANATOMY. PREVIOUSLY AND CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT PACKAGE WAS OPENED AND THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PLASTIC COIL. THE SHEATH WAS REMOVED FROM THE DISTAL END OF THE SDS AND THE STENT CAME OFF THE BALLOON AND STAYED WITHIN THE SHEATH. IT WAS NOT IMMEDIATELY RECOGNIZED THAT THE STENT HAD COME OFF THE BALLOON. THE BALLOON WAS INSERTED INTO THE PATIENT TO DEPLOY THE STENT. THE BALLOON WAS INFLATED /DEFLATED WITH A POOR ANGIOGRAPHIC RESULT. THE STENT COULD NOT BE VISUALIZED ANGIOGRAPHICALLY. IT WAS THEN NOTICED THAT THE STENT HAD COME OFF THE BALLOON AND WAS IN THE SHEATH. ANOTHER 3.5 X 18MM VISION STENT WAS THEN SUCCESSFULLY DEPLOYED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8060431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK