BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1092144 · Received August 1, 2008

    Report

    Report Number
    2024168-2008-00624
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. DISSECTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE; A CONCLUSIVE ROOT CAUSE FOR THE DISSECTION AND THE RELATIONSHIP, IF ANY, TO THE DEVICE, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE RX XIENCE V WAS IMPLANTED IN THE PROXIMAL RCA AND A DISSECTION OCCURRED. THE DISSECTION WAS SUCCESSFULLY TREATED WITH ANOTHER DRUG ELUTING STENT. NO ADD'L 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention