BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2181822 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05333
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, CARDIAC ARREST, AND DEATH, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. IT SHOULD BE NOTED THAT THE CONTRAINDICATIONS SECTION OF THE IFU STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V 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 2.5 MM TO 4.25 MM. IN THIS CASE, THE IMPLANTATION OF THE STENT IN A SAPHENOUS VEIN GRAFT (SVG) TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 31 MONTHS AFTER XIENCE V STENTING OF THE DISTAL SAPHENOUS VEIN GRAFT AND THE DISTAL FIRST OBTUSE MARGINAL CORONARY ARTERY, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST AT HOME. EMERGENCY MEDICAL SERVICES WAS DISPATCHED, CARDIOPULMONARY RESUSCITATION WAS STARTED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS PRONOUNCED DEAD ON ARRIVAL. THE DEATH CERTIFICATE LISTED MYOCARDIAL INFARCTION AS THE PRIMARY CAUSE OF DEATH, ALONG WITH HYPERTENSION, AND ATHEROSCLEROTIC VASCULAR DISEASE. 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 7110141

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death XIENCE V 2.5X15