BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903912 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02484
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ABBOTT VASCULAR ATTEMPTED TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS INSIDE THE PATIENT. THE LOT NUMBER WAS NOT IDENTIFIED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY AFTER THE IMPLANTATION OF ONE 2.5 X 28 XIENCE V STENT IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE 2.5 X 23 XIENCE V STENT IN THE MID LAD, THE PATIENT EXPERIENCED ANGINA, WAS FOUND TO HAVE ELEVATED CK-MB, AND WAS DIAGNOSED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION THAT WAS TREATED WITH NITROGLYCERIN. THE PATIENT'S CONDITION RESOLVED WITHOUT SEQUELA TWO DAYS POST PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PT'S DOCTOR CHANGED HER DOSE FOR A DAY OR TWO AFTER THE HIGH RESULTS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| S