BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2180340 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05322
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    January 24, 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. USED TO TREAT LESION GREATER THAN 28 MM IN LENGTH. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED IN A 30MM LONG LESION, IT SHOULD BE NOTED THAT THE XIENCE V 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 REPORTED IFU DEVIATION DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWENTY NINE MONTHS POST STENTING PROCEDURE IN A 30MM LONG LESION IN THE PROXIMAL CIRCUMFLEX WITH TWO XIENCE V 2.5 X 18 STENTS, THE PATIENT DIED. THE DEATH WAS DISCOVERED THROUGH THE DEATH INDEX DURING A THREE YEAR FOLLOW UP. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE INDICATES CARDIOPULMONARY ARREST AND END STAGE LIVER FAILURE. 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 7102241

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death XIENCE V 2.5 X 18