BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3102892 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03037
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OR STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A RE-STENOSED NON-BSC STENT LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X8MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE OSITAL RCA, FOLLOWING DEPLOYMENT THE PHYSICIAN NOTED THAT THE STENT WAS FRACTURED OR DEFORMED DUE TO THE OSTIAL LOCATION. THE STENT DELIVERY BALLOON WAS RE-INFLATED TO A HIGH PRESSURE TO TREAT THE DAMAGED STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204157 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408400 15247211

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention