BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3021184 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01690
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: DEVICE ANALYSIS OF THE RETURNED DEVICE REVEALED A SHAFT BREAK AND KINKING TOGETHER WITH DAMAGE TO THE INNER AND OUTER LUMENS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE NOTED A BREAK IN THE MID SHAFT APPROXIMATELY 247MM PROXIMAL FROM THE TIP. THE DEVICE WAS RETURNED IN TWO SEPARATE SECTIONS. THE GUIDEWIRE WAS RETURNED STILL INSERTED IN THE DEVICE, AND ALL ATTEMPTS TO REMOVE IT FAILED DUE TO THE SEVERITY OF DAMAGE PRESENT. THERE WAS ALSO SOME BUNCHING OF THE INNER AND OUTER LUMENS, WHICH IS CONSISTENT WITH A RESTRICTION DURING GUIDEWIRE WITHDRAWAL. THIS DAMAGE WAS LOCATED APPROXIMATELY 80MM FROM THE PROXIMAL EDGE OF THE STENT. FURTHER REVIEW ALSO FOUND MINOR KINKING AT VARIOUS INTERVALS ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND STENT WAS 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 ANY POSITIVE PRESSURE. NO FURTHER DAMAGE WAS NOTED ON THE RETURNED 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, A NO CROSS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PREDILATATION, THE PHYSICIAN ADVANCED THE 2.50 X 24MM PROMUS ELEMENT STENT DELIVERY SYSTEM TO THE LESION BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123461 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424250 15303271

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR