BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2855138 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07648
    Event Type
    Death
    Date Received
    December 3, 2012
    Date of Event
    August 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND DEATH, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THE IFU STATES: THE XIENCE V EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (XIENCE STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25MM TO 4.25MM. THE IFU FURTHER WARNS: DO NOT EXCEED RBP. OVERALL, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, HOWEVER, 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) 2008, A XIENCE STENT WAS IMPLANTED IN A DE NOVO, SAPHENOUS VEIN GRAFT ARTERY AT 20 ATMOSPHERES AND ON (B)(6) 2012, APPROXIMATELY 45 MONTHS LATER THE PATIENT WAS FOUND ON THE BATHROOM FLOOR, IN HIS HOME, BY THE POLICE, DECEASED. THE CAUSE OF DEATH HAS BEEN DETERMINED AS ISCHEMIC CARDIOMYOPATHY ON THE DEATH CERTIFICATE. THERE WAS NO ADDITIONAL INFORMATION 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 8052842

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death