BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4130415 · Received September 30, 2014

    Report

    Report Number
    2134265-2014-05878
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    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 A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE POST DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 30MM TARGET LESION WAS A DE NOVO, ECCENTRIC LESION LOCATED IN THE NON CALCIFIED AND NON TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PREDILATATION, A 2.75MM X 32MM PROMUS ELEMENT ¿ STENT WAS DEPLOYED IN THE TARGET LESION. THE PHYSICIAN INTRODUCED A POST DILATATION BALLOON AND AS SOON AS THE BALLOON CATHETER TOUCHED THE PROXIMAL APPOSED PART OF THE STENT, THE STENT GOT DEFORMED. THE PHYSICIAN DEPLOYED A 3.0MMX16MM PROMUS ELEMENT ¿ STENT TO COVER UP THE DEFORMED PART AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE.. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608889 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332270

    Patients

    Seq Age Sex Outcome Treatment
    1