BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3761244 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-02000
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 6FR NON BSC GUIDE CATHETER WAS USED. THEN A 3.50MM X 28MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240972 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918428350 16419902

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: HEARTRAIL 6FR (TERUMO)| GUIDE WIRE: SION 0.014 INCH (ASAHI INTECC)| BALLOON CATHETER: POWERED LACROSSE 3.5×15