BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2964140 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00905
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    July 3, 2012
    Report Date
    February 7, 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. AGE ESTIMATED BASED ON MEDIAN AGE. PATIENT GENDER ENTERED AS MALE BASED ON MEDIAN GENDER. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. 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 ADVERSE EVENT. 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 PROMUS STENT IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECTS ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT#.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THIS STUDY SOUGHT TO ASSESS THE INCIDENCE OF ANGIOGRAPHIC FAILURE AFTER SUCCESSFUL CHRONIC TOTAL OCCLUSION (CTO) DRUG-ELUTING STENT (DES)-SUPPORTED PERCUTANEOUS CORONARY INTERVENTION (PCI). IT WAS REPORTED THAT MULTIPLE STENTS WERE USED DURING THE PROCEDURES INCLUDING XIENCE V OR PROMUS STENTS, ALONG WITH NON-ABBOTT DES STENTS. IT WAS REPORTED THAT FROM 2003 TO 2010, 1,035 PATIENTS UNDERWENT PCI FOR A LEAST 1 CTO (>3 MONTHS). OF THESE, 802 (77%) HAD A SUCCESSFUL PCI. THE ANGIOGRAPHIC RATE WAS 82%. CLINICAL OUTCOMES WERE AS FOLLOWS: 20.0% INSTENT RESTENOSIS OR REOCCLUSION; 12.8 % CTO VESSEL REPEAT PCI; 0.9 % MYOCARDIAL INFARCTION; 0.4 % STENT THROMBOSIS; 3.2 % CARDIOVASCULAR DEATH; 16.0 % MAJOR ADVERSE CARDIOVASCULAR EVENT (INCLUDING CTO, CABG, NONFATAL MI, CARDIOVASCULAR DEATH). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66708 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death