BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2936021 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00289
    Event Type
    Death
    Date Received
    January 30, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, AN ALLERGIC REACTION AND VESSEL THROMBOSIS RESULTED IN PATIENT DEATH. THE PATIENT ARRIVED IN CATH LAB WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). DURING THE DIAGNOSTIC PORTION OF CASE, THE PATIENT'S PRESSURES WERE STABLE. IMMEDIATELY UPON IMPLANTATION OF A 4.0 MM PROMUS ELEMENT STENT, THE PATIENT BEGAN TO COMPLAIN OF ITCHING AND STARTED COUGHING. THE PHYSICIAN AND STAFF ADMINISTERED EPINEPHRINE AND PERFORMED CPR AS PATIENT'S SYMPTOMS WORSENED. PATIENT CODED. DURING CPR, PHYSICIAN NOTICED UNDER FLUORO THAT THE LEFT MAIN ARTERY HAD THROMBOSED. HE ATTEMPTED TO OPEN THE LEFT MAIN ARTERY, BUT PATIENT DIED ON TABLE. THE PHYSICIAN REPORTED THE PATIENT SUFFERED ANAPHYLACTIC REACTION TO "SOMETHING" AND DIED ON THE TABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41192 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 41 YR Death