BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRII CORONARY BALLOON STENT

    MDR report key: 115621 · Received August 27, 1997

    Report

    Report Number
    1820334-1997-00100
    Event Type
    Other
    Date Received
    August 27, 1997
    Date of Event
    July 30, 1997
    Report Date
    July 31, 1997
    Manufacturer
    COOK INCORPORATED
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPTED PLACEMENT IN A HIGHLY CALCIFIED LESION, THE STENT SLIPPED OFF THE BALLOON. THE STENT SLIPPED DISTALLY AND WAS LOST IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRII CORONARY BALLOON STENT Implant CORONARY STENT MAF COOK INCORPORATED NA 721711A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other