BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4862573 · Received June 23, 2015

    Report

    Report Number
    2134265-2015-03677
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    April 6, 2015
    Report Date
    May 25, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. NO ISSUES WERE NOTED WITH THE BUMPER TIP PROFILE. THE STENT STRUTS AT THE PROXIMAL END OF THE STENT WERE RAISED TOGETHER AND MISALIGNED. THIS DAMAGE IS CONSISTENT WITH THE STENT MEETING A RESISTANCE OR AN OBSTRUCTION DURING THE WITHDRAWAL OF THE DEVICE. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED, EVENLY FOLDED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUE WITH THE MARKERBANDS PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE ON THE SHAFT POLYMER EXTRUSION PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS POSITIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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) 2015. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 32X2.25MM, WITH A >=90 DEGREE BEND TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). A 2.25X32MM PROMUS ELEMENT ¿ STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405989 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332220 17220668

    Patients

    Seq Age Sex Outcome Treatment
    1