BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3252755 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04737
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    October 1, 2008
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF 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. THE RX XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A RETROSPECTIVE STUDY OF CONSECUTIVE DE NOVO BIFURCATION LESIONS TREATED WITH EVEROLIMUS-ELUTING STENTS (EES) BETWEEN OCTOBER 2006 AND OCTOBER 2011 AND BIOLIMUS-ELUTING STENTS (BES) BETWEEN FEBRUARY 2008 AND MARCH 2012. OF THE 223 PATIENTS, 154 PATIENTS WERE TREATED WITH XIENCE PRIME OR XIENCE V STENTS. CLINICAL OUTCOMES AT 2-YEAR FOLLOW UP WERE AS FOLLOWS: 6.5 % TARGET LESION REVASCULARIZATION (TLR); 7.8 % TARGET VESSEL REVASCULARIZATION (TVR); 5.2 % MYOCARDIAL INFARCTION; 1.9 % CARDIOVASCULAR DEATH; 3.9 % ALL-CAUSE DEATH; NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354003 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death