BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3906754 · Received July 1, 2014

    Report

    Report Number
    2024168-2014-04260
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    September 10, 2013
    Report Date
    June 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT AGE ESTIMATED, REPORTED AS (B)(6). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384762 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0030261

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death