BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAREMETAL MINIVISION STENT

    MDR report key: 1031755 · Received April 16, 2008

    Report

    Report Number
    1031755
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GUIDANCE CRM, AQUIRED BY ABBOTT LABORATORIES MINIVISION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NON-DEPLOYMENT OF A DRUG-ELUTING STENT AND ENDOLUMINAL TRAPPING OF A STENT GUIDEWIRE DURING AGGRESSIVE PTCA INTERVENTION. THE PLACEMENT OF A DRUG-ELUTING STENT IN THE RAMUS BRANCH RESULTED IN A PROXIMAL DISSECTION. IN ATTEMPTING TO PLACE A MORE PROXIMAL STENT, THE STENT WAS PULLED OFF THE GUIDE WIRE WITHIN THE LUMEN OF THE FIRST STENT, AND MANIPULATION RESULTED IN THE TRAPPING OF THE GUIDE WIRE WITHIN THE FIRST STENT, AND THE INABILITY TO REMOVE THE GUIDE WIRE OR THE NONDEPLOYED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAREMETAL MINIVISION STENT CARDIAC STENT - MNVSN 2.25 X 12A NIQ GUIDANCE CRM, AQUIRED BY ABBOTT LABORATORIES MINIVISION 1710093010710253

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention