BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2874597 · Received December 15, 2012

    Report

    Report Number
    2134265-2012-07550
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: INITIAL VISUAL EXAMINATION OF THE DEVICE FOUND PROXIMAL STENT STRUT DAMAGE, A NUMBER OF STRUTS HAD BEEN BACK DISTALLY. THE BALLOON AND TIP 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. ABLATION WAS DONE WITH ROTATIONAL ATHERECTOMY. A 2.25 X 12 MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT STENT STRUT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. ABLATION WAS DONE WITH ROTATIONAL ATHERECTOMY. A 2.25 X 12 MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT STENT STRUT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 15404006

    Patients

    Seq Age Sex Outcome Treatment
    1