BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2518401 · Received April 5, 2012

    Report

    Report Number
    2024168-2012-02213
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    February 3, 2012
    Report Date
    March 13, 2012
    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). 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ARRHYTHMIA, DYSPNEA, AND DEATH ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 3.0X12 RX PROMUS STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. POST PROCEDURE, RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW IN THE TREATED LESION. ASPIRIN AND CLOPIDOGREL WERE PRESCRIBED AND THE PATIENT WAS DISCHARGED (B)(6) 2010. ON (B)(6) 2012, CARDIAC DEATH FROM ARRHYTHMIA OCCURRED WITH AN ONSET DATE OF (B)(6) 2012. REPORTEDLY, THE PATIENT HAD A CARDIAC ARREST AND COLLAPSED. THE PATIENT PRESENTED TO THE EMERGENCY ROOM, UNRESPONSIVE IN VENTRICULAR FIBRILLATION. DEFIBRILLATION, INTUBATION, CHEST COMPRESSIONS, AND CARDIOPULMONARY RESUSCITATION WERE PERFORMED. MEDICATION WAS ADMINISTERED. THE PATIENT HAD NO ANTECEDENT MYOCARDIAL INFARCTION. IN THE INVESTIGATORS OPINION, THE EVENT OF DEATH WAS NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE, AND NOT RELATED TO THE STUDY PROCEDURE. CLINICAL CAUSE OF DEATH INDICATES DYSPNEA, CARDIAC ARREST, VENTRICULAR FIBRILLATION, SUDDEN DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9050161

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death