BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1081593 · Received July 25, 2008

    Report

    Report Number
    2024168-2008-00606
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT IMPAIRMENT. REPORTING RATIONALE: DISLODGED STENT EMBEDDED IN VESSEL WALL. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHILE WORKING IN A HEAVILY CALCIFIED RCA, MUCH DIFFICULTY WAS EXPERIENCED CROSSING ANOTHER COMPANY'S 3.0 X 15 MM BALLOON. SEVERAL DIFFERENT SIZES OF ANOTHER COMPANY'S STENT WERE ATTEMPTED, BUT NONE WERE ABLE TO CROSS THE LESION. THE LAST ATTEMPT WAS MADE WITH THE MINI VISION, BUT IT WOULD NOT CROSS. UPON RETRACTION, IT WAS NOTICED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE STENT WAS COMPRESSED INTO THE VESSEL WALL WITH THE PLACEMENT OF TWO ADDITIONAL MINI VISIONS. 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 8020631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S