BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2821680 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06997
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    March 28, 2012
    Report Date
    October 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND ANGINA ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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

    IT WAS REPORTED THAT ON (B)(6) 2008 THREE XIENCE V STENTS WERE IMPLANTED, ONE IN THE DISTAL RIGHT CORONARY ARTERY (RCA), ONE IN THE PROXIMAL RCA AND ONE IN THE FIRST OBTUSE MARGINAL ARTERY. APPROXIMATELY 41 MONTHS POST IMPLANTATION, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAINS [ANGINA]. AN ELECTROCARDIOGRAM (ECG) WAS DONE FINDING NO ACUTE ST CHANGES CONSISTENT WITH NO MYOCARDIAL INFARCTION (MI) OCCURRENCE. CARDIAC ENZYMES WERE DRAWN REVEALING AN ELEVATION AND THE PATIENT WAS DIAGNOSED WITH A NON ST ELEVATION MI (NSTEMI). AN ANTI-PLATELET MEDICATION, CLOPIDOGREL, WAS GIVEN AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PLANNED BUT THE PATIENT DEVELOPED A DRASTIC DECREASE IN MENTAL STATUS. THE PATIENT WAS MONITORED AT THE HOSPITAL AND THE PCI WAS POSTPONED. THE PATIENTS CARDIAC ENZYMES DECREASED AND THE PATIENT'S MENTAL CHANGES AND ANGINA RESOLVED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8051761

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R| S