BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 7910285 · Received September 26, 2018

    Report

    Report Number
    3007284313-2018-00272
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 29, 2018
    Report Date
    August 19, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10/11: ADDITIONAL MANUFACTURER NARRATIVE/CORRECTED DATA - THIS REPORT IS A FOLLOW UP TO MFR. REPORT # 3007284313-2018-00272 TO INCLUDE THE 510K NUMBER FOR THIS PRODUCT. G5: 510(K) NUMBER: K172567.

    Description of Event or Problem · 0

    ON (B)(6), 2018, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ISOLATED RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC® BRANCH ENDOPROSTHESIS. AFTER THE DEVICE WAS IMPLANTED, AN AORTIC MOLDING AND OCCLUSION BALLOON (MOB) WAS USED FOR BALLOONING AT THE PROXIMAL END. BALLOONING RESULTED IN RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE REASON FOR THE RUPTURE WAS NOT REPORTED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE RUPTURE. THE RUPTURE WAS SEALED AND THE PATIENT TOLERATED THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ISOLATED RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC® BRANCH ENDOPROSTHESIS. AFTER THE DEVICE WAS IMPLANTED, AN AORTIC MOLDING AND OCCLUSION BALLOON (MOB) WAS USED FOR BALLOONING AT THE PROXIMAL END. BALLOONING RESULTED IN RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE REASON FOR THE RUPTURE WAS NOT REPORTED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE RUPTURE. THE RUPTURE WAS SEALED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749709 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 18165940 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R