BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1063400 · Received June 19, 2008

    Report

    Report Number
    2024168-2008-00505
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: FRACTURED STENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: FRACTURED STENT. IT WAS REPORTED THAT A 2.25 X 18 MINI VISION WAS IMPLANTED IN THE MID LAD IN 2008, DURING A MYOCARDIAL INFARCTION (MI). THE PT RETURNED FOR INTERVENTION ON THE RCA SEVENTEEN DAYS LATER. DURING THIS INTERVENTION, A FRACTURE WAS NOTED ON THE PREVIOUSLY PLACED STENT. THE STENT APPEARS TO HAVE FRACTURED ACROSS THE DISTAL THIRD OF THE STENT. THE AREA WAS TREATED WITH ANOTHER STENT. NO ADD'L EVENT OR PT INFO 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 8021231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention