BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3122499 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03199
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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(S) ESTIMATED BASED ON DATE OF PUBLICATION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE (ABSTRACT) REVIEW. A RETROSPECTIVE COMPARISON WAS PERFORMED OF LONG-TERM CLINICAL OUTCOMES OF 204 PATIENTS AFTER REVASCULARIZATION. 154 PATIENTS WERE TREATED WITH MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS SURGERY AND 50 PATIENTS WERE TREATED WITH PERCUTANEOUS CORONARY INTERVENTIONS USING THE XIENCE DRUG-ELUTING STENT. THE AIM OF THE STUDY WAS TO COMPARE EVEROLIMUS-ELUTING STENTING WITH MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS SURGERY IN THE MANAGEMENT OF PATIENTS WITH PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY STENOSIS (ONE-VESSEL DISEASE). TWO YEAR FOLLOW-UP DATA INDICATED FIVE PATIENTS (10%) IN THE STENT GROUP NEEDED SUBSEQUENT REVASCULARIZATION OF THE TARGET VESSEL. ADDITIONALLY, NON-INFERIORITY WAS INDICATED BETWEEN THE TWO GROUPS FOR MYOCARDIAL INFARCTION. THE ARTICLE DID NOT INDICATE THE NUMBER OF MYOCARDIAL INFARCTIONS THAT OCCURRED. THE RATES OF STENT THROMBOSIS, REINFARCTION OR THE NEED OF TARGET LESION REVASCULARIZATION IN THE STENT GROUP APPEARED TO BE LESS THAN RATES FOUND IN OTHER CLINICAL STUDIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223612 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S