BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6094770 · Received November 10, 2016

    Report

    Report Number
    2024168-2016-07866
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    April 9, 2015
    Report Date
    November 10, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    00802526453151
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THROMBOSIS AND DEATH ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE OTHER PROMUS RX DEVICE REFERENCED IS FILED UNDER SEPARATE MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT A PROCEDURE IN THE PROXIMAL-MID RIGHT CORONARY ARTERY TO TREAT STABLE ANGINA. AFTER PRE-DILATATION 3.5 X 23 MM PROMUS STENT AND A 3.5 X 14 MM NON-ABBOTT STENT WERE IMPLANTED AT 14 ATMOSPHERE (ATM) AND POST-DILATATION AT 12 ATM. IN THE DISTAL RIGHT CORONARY, A 3.5 X 15 MM PROMUS STENT WAS IMPLANTED AT 14 ATM WITHOUT PRE AND POST-DILATATION. THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL BY INTRAVASCULAR ULTRASOUND (IVUS). ON (B)(6) 2012, NO ISSUE WAS NOTED IN THE PATIENT CONDITION AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE HOSPITAL WAS NOTIFIED THAT THE PATIENT DIED FROM THE PATIENT'S REGULAR PHYSICIAN. THE DATE OF DEATH WAS (B)(6) 2015. REPORTEDLY, THE PATIENT'S DEATH WAS SUSPECTED TO BE CAUSED BY VERY LATE IN-STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745981 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 00802526453151

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death STENT: 3.5X14 TERUMO NOBORI3.5X15 PROMUS