BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1692912 · Received May 7, 2010

    Report

    Report Number
    2953200-2010-00783
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: RESTENOSIS OF VESSEL. CALCIFIED PLAQUE. CONCLUSIONS: CALCIFIED PLAQUE.

    Description of Event or Problem · 1

    THE PATIENT HAD ONE COMPLETE SE STENT IMPLANTED TO THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS SUCCESSFULLY DEPLOYED. APPROXIMATELY 1 YEAR POST IMPLANT, A STENT FRACTURE WAS SEEN AT FOLLOW UP. 'EIGHT FILMS OF THE LEFT THIGH ARE OBTAINED TO EVALUATE THE STENTS IN PLACE WITHIN THE LEFT SFA. THERE IS A SOLITARY FRACTURE WITHIN THE STENTS. I CAN ONLY IDENTIFY ONE FRACTURE WITHIN THE STENTS. VISUALIZED BONY STRUCTURES OF THE LEFT FEMUR ARE NORMAL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY STENT/PROCEDURE. CD EVALUATION: REVIEW OF CINE IMAGES DETERMINED THAT THE STENT CONFORMS NICELY AROUND THE CALCIFIED PLAQUE, BENDING IN PLACES, BUT NOT BREAKING. ALL STENT STRUTS ARE STILL INTACT. THE CHARACTERISTICS OBSERVED WERE DUE TO IN-STENT RESTENOSIS. COMPLETE SE IS NOT APPROVED FOR USE IN THE US FOR SFA INDICATION, BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY/ILIAC INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00173488

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR