BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130777 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03297
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    November 11, 2012
    Report Date
    May 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF DEATH ESTIMATED AS (B)(6) 2012. DATE OF EVENT ESTIMATED AS (B)(6) 2012. DATE OF IMPLANT ESTIMATED AS (B)(6) 2003. 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. IT SHOULD BE NOTED THAT THE IFU (SECTION 3.0) STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. 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. ARTICLE ATTACHED: THREE-YEAR FOLLOW-UP AFTER TREATMENT OF BARE-METAL STENT RESTENOSIS WITH FIRST-GENERATION OR SECOND-GENERATION DRUG-ELUTING STENTS. THIS COPY OF COPYRIGHTED MATERIAL WAS MADE AND DELIVERED TO THE GOVERNMENT UNDER A LICENSE FROM THE RIGHTS HOLDER OR ITS AUTHORIZED AGENT. NO FURTHER REPRODUCTION IS PERMITTED.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE: THREE-YEAR FOLLOW-UP AFTER TREATMENT OF BARE-METAL STENT RESTENOSIS WITH FIRST-GENERATION OR SECOND-GENERATION DRUG-ELUTING STENTS. IT WAS REPORTED THAT THIS SINGLE CENTER STUDY WHICH RAN FROM (B)(6) 2003 TO (B)(6) 2009 CONSISTED OF 264 CONSECUTIVE PATIENTS WITH BARE METAL STENT IN-STENT RESTENOSIS WITH IMPLANTATION OF 75 OF THE PATIENTS WITH XIENCE V STENTS. CLINICAL OUTCOMES WERE AS FOLLOWS: 27% MAJOR ADVERSE CARDIOVASCULAR EVENT (INCLUDING DEATH, MYOCARDIAL INFARCTION, AND TARGET LESION REVASCULARIZATION). 16% TARGET VESSEL REVASCULARIZATION; NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232010 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death