BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2936127 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00276
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 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

    IF IMPLANTED, GIVE DATE: REMOVED DATE - DEVICE WAS NOT IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED STENT DAMAGE. STRUTS THROUGHOUT THE STENT WERE STRETCHED AND MISALIGNED. 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. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    SAME CASE AS MFR REPORT #: 2134265-2013-00277. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. A NON-BSC STENT WAS PREVIOUSLY IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE PHYSICIAN NOTED THAT THE STENT HAD FRACTURED RECENTLY. A NEW PROCEDURE WAS PLANNED TO TREAT THE AREA AND A 2.5X38MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL, STENT DAMAGE WAS NOTED. THEN, A 2.5X20MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE ATRIOVENTRICULAR BRANCH. NEXT, A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE DISTAL RCA BUT WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-00277. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. A NON-BSC STENT WAS PREVIOUSLY IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE PHYSICIAN NOTED THAT THE STENT HAD FRACTURED RECENTLY. A NEW PROCEDURE WAS PLANNED TO TREAT THE AREA AND A 2.5X38MM PROMUS ELEMENT PLUS STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL, STENT DAMAGE WAS NOTED. THEN, A 2.5X20MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE ATRIOVENTRICULAR BRANCH. NEXT, A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE DISTAL RCA BUT WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40536 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438250 15529893

    Patients

    Seq Age Sex Outcome Treatment
    1 3.0X16MM PROMUS ELEMENT PLUS STENT