BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 6179214 · Received December 15, 2016

    Report

    Report Number
    2134265-2016-11583
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    July 15, 2016
    Report Date
    November 30, 2016
    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. (B)(4). DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND THAT THERE WAS A HYPOTUBE KINK AT 180 MM DISTAL FROM THE END OF THE STRAIN RELIEF. NO ISSUES WITH MID SHAFT, INNER OR OUTER POLYMER EXTRUSION. THE STENT IS DAMAGED ALMOST ACROSS ITS LENGTH STARTING FROM THE THIRD MOST DISTAL ROW TOWARDS THE PROXIMAL END WITH STRUTS DISTORTED, STRETCHED AND LIFTED FROM THE STENT PROFILE. THE STENT STRETCHED ABOUT 2.5 MM OVER THE PROXIMAL MARKERBAND. THE TIP WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. 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 DEVICE ANALYSIS COMPLETED ON 30-NOV-2016. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE MORE THAN 90% STENOSED, CONCENTRIC TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, PRE-DILATION WAS PERFORMED USING A NON-BSC BALLOON CATHETER. A 2.25X16MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. PRE-DILATION WAS PERFORMED AGAIN AT HIGH PRESSURE WITH ANOTHER NON-BSC NON-COMPLIANT BALLOON CATHETER AND ANOTHER OF THE SAME STENT WAS DEPLOYED. POST-DILATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829283 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416220 18287178

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR BALLOON CATHETER: SPRINTER| GUIDEWIRE: BALANCE MIDDLE WEIGHT