BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2873903 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-07864
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED UNIT NOTED THAT THE STENT DELIVERY SYSTEM WAS RETURNED WITHOUT THE CRIMPED STENT. MICROSCOPIC EXAMINATION OF THE RETURNED BALLOON FOUND THAT THE PROFILE OF THE BALLOON HAD SIGNIFICANT PILLOWING, INDICATING THE ORIGINAL PRESENCE OF A CRIMPED STENT. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROMUS ELEMENT 3.0X8MM WAS UNABLE TO CROSS THE LESION AND WHILE THE PHYSICIAN WAS TRYING TO DO SO THE STRUTS ON THE DISTAL PART OF THE STENT WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE PROMUS ELEMENT 3.0X8MM WAS UNABLE TO CROSS THE LESION AND WHILE THE PHYSICIAN WAS TRYING TO DO SO THE STRUTS ON THE DISTAL PART OF THE STENT WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 H7493911308300 15004531

    Patients

    Seq Age Sex Outcome Treatment
    1