BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2221224 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03586
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 9, 2011
    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. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED AND RAISED. 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. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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 REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE CATHETER WOULD NOT CROSS THE LESION. THE 85% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.50X15MM NON-BSC BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. A 2.50X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM WSA THEN ADVANCED HOWEVER IT 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 STENT DAMAGE. THIS PRODUCT IS ONLY OUS 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 H7493911324250 14109059

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 1.5X15MM FYUJIN BALLOON CATHETER