BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231786 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03750
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED WITH STENT DAMAGE. THE DISTAL AND MIDDLE SECTIONS OF THE STENT WERE SQUASHED. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED OBTUSE MARGINAL (OM). THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND THEN THE PHYSICIAN ATTEMPTED TO ADVANCE A 2.75X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE OM; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ALSO ATTEMPTED TO CROSS A 2.50X24MM LIBERTE BARE SDS AND A 2.50X24MM PROMUS ELEMENT SDS BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312270 0014194329

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 2.50X24MM LIBERTE BARE STENT| 2.50X24MM PROMUS ELEMENT STENT