BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3252757 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04739
    Event Type
    Injury
    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). DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS 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 EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE, COMPARISON OF ABLUMINAL BIODEGRADABLE POLYMER BIOLIMUS ELUTING STENTS AND DURABLE POLYMER EVEROLIMUS ELUTING STENTS IN THE TREATMENT OF CORONARY BIFURCATIONS.

    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
    353252 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S