BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 2000396 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00432
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (OCCLUSION, RESTENOSIS OF STENTED SEGMENT).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE 1 COMPLETE SE STENT WAS SUCCESSFULLY IMPLANTED TO THE PROXIMAL LEFT SFA. APPROXIMATELY 12.5 MONTHS POST INDEX PROCEDURE, IN-STENT RESTENOSIS OF THE TARGET LESION WAS DIAGNOSED BY ANGIOGRAM. A CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION WAS PERFORMED APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE. LESION PERCENT STENOSIS AT TIME OF REVASCULARIZATION WAS REPORTED TO BE 90%. A BALLOON ANGIOPLASTY AND STENT WERE USED TO TREAT THE LESION. THE TREATMENT WAS SUCCESSFUL. THE INVESTIGATOR REPORTED A DEFINITE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. THE PT RECOVERED WITH TREATMENT. COMPLETE SE SFA IS A PRE-MARKET DEVICE, BUT IS SIMILAR TO COMPLETE SE BILIARY/ILIAC WHICH IS APPROVED IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00224566

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention