BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4760124 · Received May 8, 2015

    Report

    Report Number
    2134265-2015-02783
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 17, 2015
    Report Date
    April 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ALONG THE LENGTH OF THE STENT WERE RAISED FROM THE BALLOON AND DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT ENCOUNTERING RESISTANCE WHEN ADVANCING TO THE LESION SITE/DURING WITHDRAWAL. THE RO MARKERBANDS WERE EXAMINED AND THERE WAS NO DAMAGE NOTED. THE TIP OF THE DEVICE WAS EXAMINED AND THERE WAS NO DAMAGE NOTED. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. 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 WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE ECCENTRIC IN SHAPE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED A >45 AND <90 DEGREE BEND. PREDILATION WAS PERFORMED. A 2.75MMX24MM PROMUS ELEMENT¿ PLUS STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304348 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424270 16523799

    Patients

    Seq Age Sex Outcome Treatment
    1