BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5066076 · Received September 9, 2015

    Report

    Report Number
    2024168-2015-05243
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    August 24, 2015
    Report Date
    September 9, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. CEREBROVASCULAR ACCIDENT AND DEATH ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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 ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE LOT HISTORY RECORD (LHR) WAS REVIEWED FOR THE REPORTED LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, FIBROTIC AND THROMBOSED MID LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT PRESENTED WITH ACCELERATED HYPERTENSION AND EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION. AFTER THROMBUS ASPIRATION AND PRE-DILATATION WAS PERFORMED A 2.75 X 38 MM XIENCE PRIME WAS PLACED SUCCESSFULLY. POST-DILATATION WAS PERFORMED AND THE STENT WAS CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL. TIMI 3 FLOW WAS CONFIRMED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICCU). HALF AN HOUR LATER THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT AND DESPITE ATTEMPTED LIFE SAVING EFFORTS BEING PERFORMED EXPIRED IN THE ICCU. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594534 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4110741

    Patients

    Seq Age Sex Outcome Treatment
    1 Death