BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3772286 · Received April 25, 2014

    Report

    Report Number
    2134265-2014-02276
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    January 17, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    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: THE DISTAL EXTRUSION WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED THAT THE PROXIMAL END OF THE STENT WAS BUNCHED AND PULLED OVER THE PROXIMAL MARKERBAND. NO ISSUES EXISTED WITH THE MID TO DISTAL END OF THE STENT. PROTRUDING FROM THE TIP WAS A WIRE. USING FORCE THIS WIRE WAS PULLED OUT FROM THE DEVICE. THE WIRE MEASURED APPROXIMATELY 10.5CM IN LENGTH. AS A RESULT OF THE KINKS THAT WERE PRESENT IN THE EXTRUSION IT WAS NOT POSSIBLE TO PASS A 0.014 INCH SIZE WIRE THROUGH THE WIRE LUMEN. 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)(6).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014 IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE WIRE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X28MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. UPON INSERTION OF THE STENT, IT WAS NOTED THAT THE DEVICE CAME IN CONTACT WITH A GUIDEWIRE AND IT WAS UNABLE TO ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252615 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918428250 16102651

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR