BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3013261 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01500
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). 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 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 STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT FROM THE BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN UNKNOWN BALLOON CATHETER. THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO THE TARGET LESION. DURING PULL BACK, THE STENT WAS STUCK IN THE CALCIFIED AREA, AND WAS DISLODGED. THE STENT DELIVERY SYSTEM WAS REMOVED AND AN UNKNOWN BALLOON CATHETER WAS ADVANCED TO DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116325 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention