BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 564780 · Received December 29, 2004

    Report

    Report Number
    564780
    Event Type
    Other
    Date Received
    December 29, 2004
    Date of Event
    November 26, 2004
    Report Date
    December 29, 2004
    Manufacturer
    BOSTON SCIENTIFIC-MAPLE GROVE
    Product Code
    MAF
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. PATIENT RECEIVED CONSCIOUS SEDATION AND LOCAL ANESTHESIA. A TAXUS STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. ATTENTION TURNED TO THE STENT PLACEMENT WITHIN THE PROXIMAL AND MID-RIGHT CORONARY ARTERY. THIS VESSEL WAS EXTREMELY TORTUOUS. THREE (3) EXPRESS STENTS WERE PLACED IN AN OVERLAPPING FASHION TO COVER THE LESION. AN ADDITIONAL EXPRESS 2 STENT WAS ATTEMPTED TO BE PLACED DISTALLY. THIS ATTEMPT WAS ABORTED DUE TO THE TURTUOSITY OF THE VESSEL. UPON WITHDRAWAL THROUGH THE PREVIOUSLY DEPLOYED STENTS, THE STENT WAS LOST IN THE DISTAL RIGHT CORONARY ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE STENT BY INFLATING BALLOONS WHICH PROVED UNSUCCESSFUL. GUIDE CATHETER AND WIRES REMOVED ALL TOGETHER. INCIDENT DETERMINED "NON-THREATENING" PER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC EXPRESS 2 MONORAIL CARDIAC STENT MAF BOSTON SCIENTIFIC-MAPLE GROVE REF 35050-2440 6810948

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES