BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2820527 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-06760
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE IN ITS POUCH THAT HAD BEEN OPENED, WITH THE STENT DETACHED FROM THE BALLOON. THE BALLOON, WHICH WAS FILLED WITH BLOOD, WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE STENT WAS ALSO RETURNED SEVERELY STRETCHED AND DAMAGED. KINKS WERE ALSO NOTED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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 AT UNPACKING A 4.0X16MM PROMUS ELEMENT DRUG ELUTING STENT FOR A STENTING TREATMENT PROCEDURE, "THE MISS ATTACHED STENT AND BALLOON WAS VISIBLE." NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT UNPACKING A 4.0X16MM PROMUS ELEMENT DRUG ELUTING STENT FOR A STENTING TREATMENT PROCEDURE, "THE MISS ATTACHED STENT AND BALLOON WAS VISIBLE". NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316400 15337051

    Patients

    Seq Age Sex Outcome Treatment
    1