BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3925468 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-03937
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    January 10, 2014
    Report Date
    June 12, 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 FOUND THAT THE STENT WAS DAMAGED AT THE DISTAL END. THE STRUTS ON THE MOST DISTAL ROW WERE RAISED AND MISALIGNED. THE INVESTIGATOR NOTED THAT THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE TIP WAS SLIGHTLY FLARED. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 DEVICE ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 100% STENOSED, 20X2.75MM TARGET LESION CONTAINED >=90 DEGREE BEND AND WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.75X20MM 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 DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403442 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 16003014

    Patients

    Seq Age Sex Outcome Treatment
    1