BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3243534 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04624
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION (07/09/2013). DATE OF IMPLANT ESTIMATED (07/09/2012). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT (STROKE), HEMORRHAGE (BLEEDING), AND THROMBOSIS ARE LISTED IN THE XIENCE PRIME 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 XIENCE V REFERENCED BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE ARTICLE, OPTIMAL DURATION OF CLOPIDOGREL THERAPY: THE SHORTER THE LONGER. IT WAS REPORTED THAT THIS IS A META-ANALYSIS OF FOUR TRIALS INVOLVING 8,231 PATIENTS. THE TRIALS INCLUDE USE WITH MULTIPLE STENTS INCLUDING THE XIENCE V STENT AND THE XIENCE PRIME STENT. 12-MONTH CLINICAL OUTCOMES WERE AS FOLLOWS IN ODDS RATIOS: 1.15 % ALL-CAUSE DEATH (95% CONFIDENCE INTERVAL); 2.64% MAJOR BLEEDING; 1.15 % MYOCARDIAL INFARCTION; 1.15 % STROKE; VERY LOW STENT THROMBOSIS RATES (RATIO NOT SPECIFIED). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344121 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S