BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2162932 · Received July 15, 2011

    Report

    Report Number
    2024168-2011-04973
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. IMPLANT DATE ESTIMATED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, DEATH, AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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 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 THE PATIENT PRESENTED WITH CHEST PAIN, POST STENTING PROCEDURE IN (B)(6) 2011 WITH 4 PROMUS STENTS PLACED. IT WAS REPORTED THAT THE PATIENT WAS ON PLAVIX AND NITROGLYCERIN. THE PATIENT WAS WORKING OUTSIDE IN THE YARD ON (B)(6), 2011 AND EXPERIENCED CHEST PAIN. THE PATIENT SELF ADMINISTERED 3 NITROGLYCERIN TABLETS; THE PATIENT HAD LOST CONSCIOUSNESS WHEN THE AMBULANCE ARRIVED. IT WAS SUSPECTED THAT THE PATIENT HAD BEEN UNCONSCIOUS FOR APPROXIMATELY 30-50 MINUTES. AFTER ARRIVAL AT THE HOSPITAL, 3 ADDITIONAL STENTS WERE PLACED IN THE CORONARY (TYPE UNKNOWN). THE PATIENT WAS PLACED ON HYPOTHERMIA THERAPY FOR 36 HOURS THEN PLACED ON LIFE SUPPORT (B)(6), 2011. THE PATIENT WAS REMOVED FROM LIFE SUPPORT (B)(6), 2011 (10:30AM). THE PATIENT EXPIRED AT 4:30PM THE SAME DAY. THE CAUSE OF DEATH WAS REPORTED AS MYOCARDIAL INFARCTION. THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death STENT: PROMUS (X3)