BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2335043 · Received November 14, 2011

    Report

    Report Number
    2024168-2011-07642
    Event Type
    Death
    Date Received
    November 14, 2011
    Date of Event
    May 22, 2011
    Report Date
    October 19, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. MYOCARDIAL INFARCTIONS ARE KNOWN ADVERSE PATIENT EVENTS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE OTHER TWO PROMUS STENTS, INDICATED ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECTS OF VENTRICULAR FIBRILLATION AND DEATH ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTION FOR USE AS KNOWN ADVERSE PATIENT 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 VIA A TRIAL THAT ON (B)(6) 2010, DUE TO WORSENING CARDIOMYOPATHY, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF THREE DRUG-ELUTING STENTS TO THE PROXIMAL RIGHT CORONARY ARTERY (RCA), FIRST OBTUSE MARGINAL BRANCH SEGMENT AND THE PROXIMAL CIRCUMFLEX (CX) ARTERY SEGMENT. IN ALL THREE LESIONS, POST PROCEDURAL RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON (B)(6) 2010, THE PATIENT RECEIVED THE STUDY MEDICATION CLOPIDOGREL DOSE 75.0 MG AND WAS STARTED ON ASPIRIN 325.0MG. ON (B)(6) 2010, THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF STUDY MEDICATION CLOPIDOGREL DOSE 525.0 MG. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. REPORTEDLY, ON (B)(6) 2011, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCT IN ALL THREE PROMUS STENTS PLACED IN THE INDEX PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT UPDATED INFORMATION RECEIVED STATES THE PATIENT DIED ON (B)(6) 2011. THE CAUSE OF DEATH WAS LISTED AS VENTRICULAR FIBRILLATION. THOUGH REQUESTED, 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 0031661

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| S STENT: PROMUS (X2)