BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3101976 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-02916
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED TIP DAMAGE (JAGGED LIKE EDGE). THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED STENT DAMAGE. A STRUT ON THE FOURTH ROW IN FROM THE PROXIMAL END OF THE STENT WAS RAISED UP. THE BALLOON OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, NO CROSS OCCURRED. THE 86% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. PREDILATATION WAS PERFORMED WITH A MAVERICK 2.0 X 1.5MM BALLOON CATHETER AND THE 3.0X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203807 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 14787196

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR