BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3232517 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-05074
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 28, 2013
    Report Date
    June 18, 2013
    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.: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 61.7 CM DISTAL TO THE STRAIN RELIEF. THERE WERE NO KINKS NOTED ALONG BOTH SECTIONS OF THE HYPOTUBE BREAK. NO ISSUES WERE NOTED WITH THE PROFILE OF THE CRIMPED STENT BALLOON AND TIP. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75X16MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND ADVANCED INTO THE TARGET LESION BUT WAS UNABLE TO CROSS. AFTER SEVERAL TRIES, THE COMPLAINT DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.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 HYPOTUBE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336114 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416270 15849837

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR