BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3011207 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01510
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 21, 2013
    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. (B)(4). DEVICE EVALUATED BY MANUFACTURER - INITIAL VISUAL EXAMINATION OF THE DEVICE FOUND DISTAL STENT STRUT DAMAGE AS THE STRUTS AT THE DISTAL EDGE OF THE STENT WERE KINKED. FURTHER REVIEW NOTED THAT THE SHAFT WAS SEVERELY KINKED AT APPROXIMATELY 120MM DISTAL FROM THE CATHETERS STRAIN RELIEF. NO FURTHER DAMAGE WAS NOTED WITH THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED WITH A NON-BSC BALLOON. THE 2.75X38MM PROMUS ELEMENT STENT WAS ADVANCED HOWEVER WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X38MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE HOWEVER; RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114273 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438270 15493585

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR BALLOON CATHETER: IKAZUCHI