BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3963628 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04395
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND THAT THE STENT WAS DAMAGED AT THE DISTAL END; STENT STRUTS WERE FOUND TO BE STRETCHED AND LIFTED UPWARDS FROM ITS PROFILE. NO OTHER ISSUES WERE NOTED WITH THE CRIMPED STENT AND THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER CROSSING DIFFICULTIES WERE ENCOUNTERED.  THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATION USING AN UNSPECIFIED BALLOON CATHETER, A 2.75X16MM PROMUS ELEMENT¿ PLUS STENT WAS ADVANCED HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442109 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416270 15849837

    Patients

    Seq Age Sex Outcome Treatment
    1