BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3812001 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02577
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 17, 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 EVALUATED BY MFR: A TACTILE AND VISUAL EXAMINATION FOUND THE UNIT WITH NO DEFECTS ON THE TIP SECTION OF THE DEVICE. THE BALLOON WAS NOT TIGHTLY WRAPPED AND APPEARED TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. THE STENT HAD MOVED DISTALLY OVER THE DISTAL MARKERBAND. THERE WERE VARIOUS KINKS ALONG THE HYPOTUBE. 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 ON (B)(4) 2014. IT WAS REPORTED CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX (CX) ARTERY. A 2.25X20MM PROMUS PREMIER STENT DELIVERY SYSTEM WAS SELECTED BUT WAS UNABLE TO CROSS THE LESION. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT MOVED ON BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290186 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820220 16615088

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR