BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4192377 · Received October 22, 2014

    Report

    Report Number
    2134265-2014-06362
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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 FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIGHT AND TORTUOUS LEFT CIRCUMFLEX ARTERY. A 2.25MM X 16MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION HOWEVER CROSSING DIFFICULTIES WERE ENCOUNTERED. AFTER TRYING TO PUSH THE DEVICE THROUGH THE LESION, IT GET BACK ON THE UNSPECIFIED GUIDE CATHETER. IT WAS THEN NOTED THAT THE STENT FLARED UP "A LITTLE BIT" AT THE END CLOSEST TO THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT WITH STENT INTACT ON THE DELIVERY SYSTEM BALLOON. THE LESION WAS PREDILATED AND THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED SIZE PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671734 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952816220 0016614168

    Patients

    Seq Age Sex Outcome Treatment
    1