BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3610749 · Received February 6, 2014

    Report

    Report Number
    2024168-2014-00648
    Event Type
    Death
    Date Received
    February 6, 2014
    Date of Event
    October 1, 2013
    Report Date
    January 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT HAS BEEN ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 DUE TO ACUTE CORONARY SYNDROME AND NSTEMI, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE DRUG ELUTING STENT TO PROXIMAL RIGHT CORONARY ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. THE SITE LEARNED OF THE SUBJECTS DEATH AT THE TIME OF A 30 MONTH FOLLOW-UP FROM A FAMILY MEMBER. THE PATIENT DIED ON AN UNKNOWN DAY IN (B)(6) 2013 AT HOME. THE CAUSE OF DEATH IS UNKNOWN AND NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78240 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death