BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3952609 · Received July 23, 2014

    Report

    Report Number
    2024168-2014-04705
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF SHOCK AND DEATH, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT HAD A 3.0 X 12 MM PROMUS STENT IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DUE TO ANGINA AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED FOR RESPIRATORY FAILURE, ATRIAL FIBRILLATION, END STAGE CARDIOMYOPATHY, AND END STAGE KIDNEY DISEASE. THE PATIENT UNDERWENT HEMODIALYSIS AND TREATMENT WITH MEDICATIONS. ON (B)(6) 2014, THE PATIENT EXPIRED DUE TO KIDNEY DISEASE AND CARDIOMYOPATHY. THERE WAS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431186 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8102061

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death