BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3063483 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02316
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    March 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. THE STRUTS ON THE FIRST ROW ON THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. IN ADDITION, IT WAS NOTED THAT SOME STRUTS ON THE SECOND MOST PROXIMAL STENT ROW WERE SIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. SOLIDIFIED BLOOD WAS PRESENT ON THE OUTSIDE OF THE BALLOON. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT WAS UNABLE TO CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE 3.0 X 20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164469 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 15615538

    Patients

    Seq Age Sex Outcome Treatment
    1