BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6062309 · Received October 27, 2016

    Report

    Report Number
    2024168-2016-07355
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 27, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648123559
    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE STENT REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. DEATH IS LISTED IN THE XIENCE PRIME, EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PROCEDURE WAS TO TREAT A LESION IN THE 95% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY, A LESION IN THE 90% STENOSED PROXIMAL RAMUS CORONARY ARTERY AND A LESION IN THE 90% STENOSED PROXIMAL RIGHT CORONARY ARTERY. A 2.75 X 23 MM RX XIENCE PRIME STENT AND A 2.5 X 33 MM RX XIENCE PRIME STENT WERE DEPLOYED SUCCESSFULLY DURING THE PROCEDURE. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE. THE PATIENT WAS ON A REGIMEN OF ASPIRIN AND CLOPIDOGREL AND WAS GIVEN HEPARIN DURING THE PROCEDURE. SOMETIME WITHIN 24 HOURS OF THE PROCEDURE THE PATIENT DIED AS A RESULT OF A MEDICAL COMPLICATION OF THE PROCEDURE. NO INFORMATION WAS PROVIDED AS TO NATURE OF THE MEDICAL COMPLICATION. NO REPEAT ANGIOGRAPHY OR INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713610 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6042141 08717648123559

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death STENT: 2.5 X 33 MM XIENCE PRIME