BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3932754 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04037
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    January 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DETACHED FROM THE BALLOON. 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. AN EXAMINATION FOUND NO DEFECTS ON THE BALLOON AND TIP SECTIONS OF THE DEVICE. THERE WERE VARIOUS HYPOTUBE KINKS ALONG THE LENGTH OF THE UNIT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 100% STENOSED, 20X2.5MM TARGET LESION CONTAINED A >=90 DEGREE BEND AND WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.50X20MM PROMUS ELEMENT DRUG-ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT/SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409859 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 15883988

    Patients

    Seq Age Sex Outcome Treatment
    1