BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2957524 · Received February 12, 2013

    Report

    Report Number
    2024168-2013-00828
    Event Type
    Death
    Date Received
    February 12, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 18, 2013
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. YOU ARE RECEIVING THIS REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, DUE TO STABLE ANGINA THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE DES STENTS TO THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST PROCEDURAL RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. ON (B)(6) 2009, THE SUBJECT WAS STARTED ON ASPIRIN 325 MG. THE SUBJECT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION. ON (B)(6) 2011, AT THE START OF THE STUDY THE SUBJECT RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF CLOPIDOGREL 75 MG. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2012, THE SUBJECT WAS RANDOMIZED TO CLOPIDOGREL/PLACEBO ARM, AND WAS ADMINISTERED THE FIRST DOSE ON (B)(6) 2012. ON (B)(6) 2012, 703 DAYS FOLLOWING THE INDEX PROCEDURE THE PATIENT DIED AT HOME DUE TO UNKNOWN CAUSES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT CAUSE OF DEATH WAS HEART DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61580 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0091561

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death