BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231633 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01152
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 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
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. ISCHEMIA, AS LISTED IN THE XIENCE V 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 AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN THIS CASE, IT IS LIKELY THAT THE PTCA IS A SECONDARY EFFECT OF THE ISCHEMIA. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/ MEDICAL INTERVENTION. REPORTING RATIONALE: ISCHEMIA REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT A 3.0 X 28MM XIENCE V STENT WAS DEPLOYED IN THE LAD. AFTER DEPLOYMENT OF THE STENT, TIMI 1 FLOW WAS NOTED AND THE DIAGONAL BRANCH WAS FOUND TO HAVE BEEN JAILED. PTCA WAS DONE TO TREAT THE JAILED SIDE BRANCH. 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 8053041

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention