BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2862960 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07247
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE STENT DAMAGE AND REMOVAL DIFFICULTY OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY (LCX). A 2.50X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE TARGET LESION. DURING WITHDRAWAL OF THE PROMUS ELEMENT SDS DIFFICULTY WAS ENCOUNTERED. AFTER REMOVAL OF THE PROMUS ELEMENT SDS, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED, "LIFTED UP". THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50X12MM PROMUS ELEMENT SDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312250 15247566

    Patients

    Seq Age Sex Outcome Treatment
    1