BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 3351522 · Received September 17, 2013

    Report

    Report Number
    9612164-2013-00911
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    March 28, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENOSIS). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (STENOSIS). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PHYSICIAN USED ONE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE SFA TO POPLITEAL OF THE RIGHT LEG. THE TARGET LESION WAS DUE TO IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED COMPLETE SE STENT. THE STENOSIS EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH DEVICE. COMPLETE SE IS UNDER IDE INVESTIGATION FOR SFA INDICATION. FOR PURPOSES OF MDR, COMPLETE SE SFA IS CONSIDERED THE SAME AS COMPLETE SE ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468889 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention CLOPIDOGREL AND ASPIRIN