BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2901313 · Received January 8, 2013

    Report

    Report Number
    2024168-2013-00143
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    June 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED AS DATE OF PUBLICATION. 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 ADDITIONAL ADVERSE PATIENT EFFECTS CAPTURED IN THE ARTICLE ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, RANDOMIZED COMPARISON OF CONSERVATIVE VERSUS AGGRESSIVE STRATEGY FOR PROVISIONAL SIDE BRANCH INTERVENTION IN CORONARY BIFURCATION LESIONS RESULTS FROM THE SMART-STRATEGY (SMART ANGIOPLASTY RESEARCH TEAM OPTIMAL STRATEGY FOR SIDE BRANCH INTERVENTION IN CORONARY BIFURCATION LESIONS) RANDOMIZED TRIAL. IT WAS NOTED IN THE ARTICLE THAT EVEROLIMUS-ELUTING STENTS WERE USED IN SOME PROCEDURES. IN THIS PROSPECTIVE RANDOMIZED TRIAL, 258 PATIENTS WITH A CORONARY BIFURCATION LESION TREATED WITH DRUG-ELUTING STENTS WERE RANDOMIZED TO A CONSERVATIVE OR AGGRESSIVE SIDE-BRANCH INTERVENTION STRATEGY. OF THE 258 PATIENTS, CLINICAL OUTCOMES WERE AS FOLLOWS: 0.08 % CARDIAC DEATH, 0.08 % STENT THROMBOSIS, 23.2 % PROCEDURE-RELATED MYOCARDIAL NECROSIS, 7.8 % TARGET BIFURCATION REVASCULARIZATION, 13.2% TARGET LESION REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9881 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death