BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5029089 · Received August 25, 2015

    Report

    Report Number
    2024168-2015-04849
    Event Type
    Death
    Date Received
    August 25, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 26, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH, HYPOTENSION, AND THROMBOSIS, AS LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. 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 MANUFACTURING, DESIGN OR LABELING OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE 2.5 X 38 MM XIENCE ALPINE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS LOCATED OFF THE LEFT MAIN IN THE BIFURCATION OF THE CIRCUMFLEX (CX) AND THE RAMUS ARTERIES. THE PATIENT WAS TRANSFERRED FROM AN OUTLYING HOSPITAL AFTER BEING DIAGNOSED AS HAVING EXPERIENCED A NON-ST MYOCARDIAL INFARCTION FOR A PLANNED PROCEDURE. THERE WAS NO EVIDENCE OF EXISTING THROMBOSIS PRIOR TO STENTING WITH THE 2.5 X 23 MM XIENCE ALPINE STENT IN THE CX AND THE 2.5 X 38 MM XIENCE ALPINE STENT IN THE RAMUS. THE STENTS WERE CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL ON ANGIOGRAPHY. THERE WAS NO RESIDUAL STENOSIS AND THE PATIENT HAD TIMI III FLOW. THE PATIENT WAS TRANSFERRED FROM THE CATH LAB. APPROXIMATELY 10 MINUTES LATER THE PATIENTS BLOOD PRESSURE WAS BOTTOMING OUT AND WAS UNDER CARDIAC ARREST AND WAS RETURNED TO THE CATH LAB. AN ABRUPT CLOSURE OF THE STENTS WAS OBSERVED. CPR WAS STARTED AND AN IMPELLA CP DEVICE PLACED IN THE LEFT VENTRICLE. ECHO WAS PERFORMED WHICH DEMONSTRATED THE SEPTUM WAS THE ONLY SIGNIFICANT SOURCE OF SYSTOLIC FUNCTION. THE PREVIOUS SAPHENOUS VEIN GRAFT WAS PATENT. SURGERY WAS CONSULTED; HOWEVER, IT WAS DETERMINED THAT SURGERY WOULD NOT REDUCE PATIENT MORTALITY. SUBSEQUENTLY, THE PATIENT EXPIRED ON THE TABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562873 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5042941

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death