BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140990 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03440
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    December 27, 2011
    Report Date
    May 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE REPORTED PATIENT EFFECTS OF ANGINA, DEATH, AND MYOCARDIAL INFARCTION, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE 3.0 X 15 MM PROMUS STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE PATIENT REPORTED CHEST PAIN ON (B)(6) 2011; HOWEVER, NO TREATMENT WAS NOTED. ON (B)(6) 2013, THE PATIENT PRESENTED WITH RESPIRATORY FAILURE AND NON Q-WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS HOSPITALIZED THE SAME DAY. THE PATIENT WAS NOT ON DUAL ANTIPLATELET MEDICATION. ASPIRIN AND THE STUDY DRUG PER PROTOCOL WERE LAST TAKEN ON AN UNKNOWN DATE IN 2013. THE SUBJECT DID NOT TAKE ANY OTHER ANTIPLATELET MEDICATION DURING THE STUDY. ON (B)(6) 2013, THE PATIENT DIED DUE TO ACUTE ON CHRONIC RESPIRATORY FAILURE DUE TO METASTATIC ENDOMETRIAL CANCER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244436 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0081341

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death