BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 817651 · Received February 2, 2007

    Report

    Report Number
    6000093-2007-00252
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 2, 2007
    Report Date
    January 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS COULD NEITHER CONFIRM NOR DENY AND STENT DISLODGEMENT STATED IN THE COMPLAINT. THE ORIGINAL STENT ADHERED TO THE SNARE WIRE WAS RECEIVED AND DAMAGE WAS OBSERVED TO THE STENT. THE DELIVERY DEVICE WAS NOT RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC EXAMINATION OF THE DAMAGED STENT DID NOT REVEAL ANY INHERENT MATERIAL DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE DISLODGEMENT OR STENT DAMAGE. AS THE DELIVERY DEVICE WAS NOT RETURNED FOR ANALYSIS, THE EXACT CAUSE FOR THE STENT DISLODGEMENT AND STENT DAMAGE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 6813069 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE STENT DISLODGEMENT AND STENT DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE CALCIFIED AND TORTUOUS LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE LESION (RESISTANCE) AND DIFFICULTY DURING WITHDRAWAL. WHILE ATTEMPTING TO WITHDRAW THE STENT DELIVERY SYSTEM, THE STENT DISLODGED. THE STENT WAS SUCCESSFULLY REMOVED WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PATIENT STATUS IS REPORTED "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 6813069

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR