BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1132087 · Received August 21, 2008

    Report

    Report Number
    2024168-2008-00697
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 28, 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

    THE SECOND XIENCE V IS BEING FILED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. ANGINA, MYOCARDIAL INFARCTION, AND THROMBOSIS, AS LISTED IN THE XIENCE V IFU, ARE KNOWN RISKS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUAL ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT. IT IS LIKELY THAT THE ANGINA, ECG CHANGES, PTCI AND MYOCARDIAL INFARCTION ARE SECONDARY EFFECTS OF THE THROMBOSIS WHICH REQUIRED HOSPITALIZATION. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE DATE OF INDEX PROCEDURE WAS 2008. THE ADVERSE EVENT STARTED FIVE DAYS LATER. THE PT WAS EXPERIENCING CHEST PAIN. AN ECG WAS TAKEN, WHICH SHOWED AN ACUTE ANTERIOR WALL MI. ANGIOGRAPHY WAS PERFORMED WHICH SHOWED IN-STENT THROMBOSIS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE ON THE SAME DAY. FINDINGS OF ST-ELEVATION MI, WAS BASED ON Q-WAVE MI. NO ADDITIONAL EVENT OR PT INFO 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 8013141

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R STENT: XIENCE V (PART # 1009527-12