BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRII CORONARY BALLOON STENT

    MDR report key: 119912 · Received September 16, 1997

    Report

    Report Number
    1820334-1997-00112
    Event Type
    Other
    Date Received
    September 16, 1997
    Date of Event
    August 3, 1997
    Report Date
    August 18, 1997
    Manufacturer
    COOK, INCORPORATED
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE STENT WAS ADVANCED AND DEPLOYED IN THE RCA. UPON WITHDRAWAL, THE STENT CAME BACK ON THE BALLOON. STENT BECAME STUCK ON TIP OF GUIDING CATHETER. PHYSICIAN ATTEMPTED TO REMOVE STENT: HOWEVER, STENT DISLODGED AND WAS LOST IN PT. NO ATTEMPT WAS MADE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRII CORONARY BALLOON STENT Implant CORONARY STENT MAF COOK, INCORPORATED NA 696814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention