BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3005200 · Received March 14, 2013

    Report

    Report Number
    2024168-2013-01474
    Event Type
    Death
    Date Received
    March 14, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTEDLY, THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO THE STENTS. PATIENT WAS REPORTEDLY COMPLIANT WITH MEDICATION PATIENT HAS A HISTORY OF CORONARY REVASCULARIZATION AND RENAL INSUFFICIENCY/FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 U.S. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND DEATH ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE 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, DUE TO A POSITIVE STRESS TEST, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF TWO RX PROMUS STENTS (2.75X18 AND 2.75X12) TO THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST PROCEDURAL RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. ON (B)(6) 2010, THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION CLOPIDOGREL 300 MG. ON (B)(6) 2010, THE SUBJECT WAS STARTED ON ASPIRIN 325 MG, RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF CLOPIDOGREL 75 MG AND WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT WAS RANDOMIZED TO CLOPIDOGREL/PLACEBO ARM, AND WAS ADMINISTERED THE FIRST DOSE ON (B)(6) 2011. ON (B)(6) 2013, THE PATIENT EXPERIENCED THE EVENT OF FATAL CARDIAC ARREST. REPORTEDLY, THE PATIENT COLLAPSED AND DIED AT HOME. EMERGENCY MEDICAL SERVICES (EMS) PERSONNEL PERFORMED CARDIOPULMONARY RESUSCITATION AT HOME AND IN THE AMBULANCE, AND CONTINUED IN THE HOSPITAL EMERGENCY ROOM WHERE THE PATIENT WAS PRONOUNCED DEAD. AS PER THE NURSING ASSESSMENT, THE PATIENT WAS NON-RESPONSIVE, NON-VERBAL, HAD NO GAG REFLEX AND HAD A CYANOTIC FACE. THE PATIENT WAS APNEIC. THE INVESTIGATOR CONSIDERED THE EVENT OF FATAL CARDIAC ARREST AS MILD IN INTENSITY, AND NOT RELATED TO THE STUDY DRUG, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. DEATH CERTIFICATE LISTS CAUSES OF DEATH IN THE FOLLOWING ORDER: CARDIAC ARREST, MASSIVE MYOCARDIAL INFARCTION VERSUS MASSIVE PULMONARY EMBOLISM, CORONARY ARTERY DISEASE, RENAL INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107814 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062461

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death STENT: RX PROMUS 2.75X12