BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3061159 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02699
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STENT HAD MOVED DISTALLY ON THE BALLOON BY 6MM. THE STENT WAS STRETCHED AND DAMAGED ALONG ITS LENGTH. THE STRUTS ON THE DISTAL END WERE ALL BUNCHED UP TOGETHER AND THE STRUTS ON THE PROXIMAL END WERE RAISED UP. THE BALLOON 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 BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163423 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312400 15385862

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention