BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 1490067 · Received October 1, 2009

    Report

    Report Number
    2953200-2009-01364
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 3, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODE, RESULTS: (OCCLUSION).

    Description of Event or Problem · 1

    THE PATIENT HAD A COMPLETE SE ILIAC STENT DEPLOYED TO THE MID SUPERFICIAL FEMORAL ARTERY WITH EXCELLENT ANGIOGRAPHIC RESULT. THE PATIENT'S SYMPTOMS IMMEDIATELY RESOLVED AND PATIENT IS WELL. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, THE PATIENT STARTED TO COMPLAIN ABOUT RECURRENT CALF PAIN WITH AMBULATION. INCREASED FLOW VELOCITY WAS INDICATED WITHIN THE PREVIOUSLY STENTED SEGMENT. AN ARTHRECTOMY WAS PERFORMED AND A LARGE VOLUME OF ATHEROMA WAS REMOVED. THE OBSTRUCTION WAS REDUCED FROM 95% TO APPROXIMATELY 20-30%. FOLLOW UP IMAGES SHOW 2 FOCAL AREA OF PERSISTENT NARROWING WHICH APPEARED TO BE RELATED TO SLIGHTLY UNDER-DEPLOYED SEGMENTS OF THE PREVIOUS DEPLOYED SELF EXPANDING STENT. THE AREA WAS TREATED BY BALLOON ANGIOPLASTY. FINAL ANGIOGRAM SHOWED 20% OR LESS RESIDUAL NARROWING. THE INVESTIGATOR HAS NOT INDICATED WHETHER THE REPORTED EVENT IS RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA FGE MEDTRONIC CARDIOVASCULAR NA V00222977

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention HOURS PRIOR TO REPORTED EVENT.| THE PATIENT WAS ON DUAL ANTI-PLATELET THERAPY 24 | HOURS PRIOR TO REPORTED EVENT.| THE PATIENT WAS ON DUAL ANTI-PLATELET THERAPY 24