BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1180159 · Received September 26, 2008

    Report

    Report Number
    2024168-2008-00847
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    July 4, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE DEVICE BECAUSE IT WAS NOT RETURNED FOR ABBOTT VASCULAR FOR EVALUATION. MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE V RISK ASSESSMENT AND INSTRUCTIONS FOR USE (IFU), IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT DAMAGE. REPORTING RATIONALE: PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ONE DAY FOLLOWING STENT IMPLANTATION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). REPORTEDLY, THERE WAS NO INTERVENTION PERFORMED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8030641

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Disability