BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2260618 · Received September 22, 2011

    Report

    Report Number
    2024168-2011-06511
    Event Type
    Death
    Date Received
    September 22, 2011
    Date of Event
    March 11, 2011
    Report Date
    August 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    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 PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. CARDIAC ARREST, VENTRICULAR FIBRILLATION, AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE COULD NOT 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) 2011, A NON-ABBOTT STENT WAS ADVANCED INTO THE PATIENT ANATOMY AND IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED XIENCE STENT WAS THEN ADVANCED INTO THE PATIENT ANATOMY AND WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING, IN A MANNER SO THAT THE STENTS WERE OVERLAPPING. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU). ON (B)(6) 2011, THE PATIENT WAS TRANSFERRED FROM THE CCU TO A MEDICAL WARD. ON (B)(6) 2011, BLOOD TESTS WERE DONE AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WENT INTO CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION WAS ATTEMPTED; HOWEVER, THE PATIENT DIED. THE CAUSE OF DEATH IS NOT KNOWN; HOWEVER, THE PATIENT EXHIBITED ABNORMAL CARDIAC RHYTHM, POSSIBLY VENTRICULAR FIBRILLATION. THE PATIENT'S CONDITION DECLINED RAPIDLY AND NO ELECTROCARDIOGRAM OR ANGIOGRAPHY WAS PERFORMED. FROM (B)(6) 2011, THE PATIENT HAD BEEN ON AN ANTI-PLATELET REGIME OF ASPIRIN AND CLOPIDOGREL. AN AUTOPSY WAS NOT PERFORMED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STENT: ENDEAVOR