BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL BILIARY EXTRA SUPPORT ON AVED

    MDR report key: 301825 · Received October 26, 2000

    Report

    Report Number
    2953738-2000-00061
    Event Type
    Injury
    Date Received
    October 26, 2000
    Date of Event
    September 25, 2000
    Report Date
    September 26, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    FGE
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 5.0MM DIAMETER X 17MM LENGTH MEDTRONIC AVE BILIARY STENT WAS INSERTED INTO THE TORTUOUS RENAL ARTERY. THE LESION WAS PRE-DILATED WITH AN UNKNOWN SIZE BALLOON AND IT WAS NOTED THAT THERE WAS A 30% RESIDUAL STENOSIS. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION, THEREFORE, THE STENT WAS RETRACTED FROM THE TARGET VESSEL. UPON REMOVAL OF THE STENT AND STENT DELIVERY SYSTEM, THE STENT DISLODGED FROM THE DELIVERY BALLOON. SUBSEQUENTLY, THE STENT WAS DEPLOYED IN THE ILIAC ARTERY. A SECOND ATTEMPT TO DEPLOY AN ADDITIONAL MEDTRONIC AVE BILIARY STENT WAS ATTEMPTED BUT THE STENT BECAME DISLODGED FROM THE BALLOON IN THE GUIDING CATHETER. THE STENT WAS SUCCESSFULLY RETRIEVED BY REMOVING THE GUIDING CATHETER THAT CONTAINED THE THE STENT. A THIRD MEDTRONIC AVE BILIARY STENT WAS THEN SUCCESSFULLY DEPLOYED INTO THE RENAL ARTERY. IT WAS REPORTED THAT THE PT IS DOING WELL, AND THERE WERE NO ADDITIONAL SEQUELAE REPORTED TO THE EVENT. A SEPARTE MEDWATCH REPORT WAS SUBMITTED FOR EACH DEVICE INVOLVED IN THIS EVENT. THERE WERE NO DEVICES RETURNED FOR EVAL. DEVICE HISTORY REPORT REVEALS NO ISSUES RELEVANT TO THIS COMPLAINT.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE IT WAS DETERMINED THAT THE DEVICE CORRESPONDS TO THE INFO GIVEN FOR THE XB 617 EXTRA SUPPORT BILIARY STENT. THE DESCRIPTION OF THE EVENT REMAINS UNCHANGED HOWEVER THE DEVICE DESCRIPTION WAS REVERSED. REFERENCE MEDWATCH REPORT #2953738-2000-00062. THE RETURNED DEVICE INVESTIGATION REVEALED THAT THE DEVICE AND STENT WERE RETURNED SEPARATE. ALL OF THE STENT SEGMENTS ARE PRESENT. THE BALLOON HAD EVIDENCE THAT THE STENT HAD BEEN ADEQUATELY MOUNTED ONTO THE BALLOON. THE BALLOON APPEARED TO BE SLIGHTLY INFLATED AND ONE END OF THE STENT WAS SLIGHTLY FLARED, LIKELY DUE TO THE SLIGHT INFLATION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL BILIARY EXTRA SUPPORT ON AVED PERIPHERAL STENT SYSTEM FGE MEDTRONIC AVE PERIPHERAL DIVISION NA OE10E03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention