BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3921534 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03887
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT THE PROXIMAL END. THE STRUTS ON THE MOST PROXIMAL ROW WERE RAISED UPWARDS. THE STENT OD WAS MEASURED AT SEVERAL POINTS DISTAL TO THE DAMAGED STRUT USING A DIGITAL SNAP GAUGE AND ALL MEASUREMENTS VARIED BETWEEN 1.02MM AND 1.05MM WHICH IS WITHIN SPECIFICATION. THE STENT PROTECTOR WAS NOT RETURNED TO THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. THE BALLOON AND TIP 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 TIP OD WAS MEASURED TO BE 0.0255IN WHICH IS WITHIN SPECIFICATION. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. IT WAS ALSO NOTED THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS 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 APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 95% STENOSED, 30MM IN LENGTH, 2.75MM IN DIAMETER, CONCENTRIC AND THE DE NOVO LESION BEING TREATED WAS LOCATED IN THE NON TORTUOUS AND MILDLY CALCIFIED OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED <=45 DEGREE BEND. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. PREDILATION WAS PERFORMED USING A 2.0X10MM NON-BSC BALLOON CATHETER, LEAVING 70% RESIDUAL STENOSIS IN THE LESION. A 2.75X32MM PROMUS ELEMENT STENT WAS SELECTED TO TREAT THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH A 2.75X32MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402101 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332270 15771247

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR