BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3231481 · Received July 17, 2013

    Report

    Report Number
    2024168-2013-04473
    Event Type
    Death
    Date Received
    July 17, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    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 PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH, THROMBOSIS, HEART FAILURE, AND SHOCK AS LISTED IN THE JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS 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 WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. DURING THE PROCEDURE, PRE-DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON. A 3.0X18 RX XIENCE PRIME STENT WAS IMPLANTED IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY FOR TREATMENT OF A 99% STENOSIS. INTRAVASCULAR ULTRASOUND WAS PERFORMED AS STANDARD PROCEDURE. POST-DILATATION WAS PERFORMED AND THE STENT WAS CONFIRMED TO BE FULLY EXPANDED. ON (B)(6) 2013 WHILE STILL IN THE HOSPITAL, THE PATIENT'S ENZYMES WERE SLIGHTLY ELEVATED. ON (B)(6) 2013, ENZYMES WERE ELEVATED AND CARDIOGENIC SHOCK OCCURRED. CORONARY ANGIOGRAPHY WAS PERFORMED AND STENT THROMBOSIS WAS OBSERVED. INTRA-AORTIC BALLOON PUMP WAS PLACED. THROMBECTOMY AND BALLOON ANGIOPLASTY WERE PERFORMED. THE PATIENT REMAINED UNCONSCIOUS. ON (B)(6) 2013, ACUTE EXACERBATION OF CARDIAC FAILURE OCCURRED AND THE PATIENT DIED. THE REPORTED CAUSE OF DEATH IS CARDIOGENIC SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331294 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072041

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death