BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9074040 · Received September 16, 2019

    Report

    Report Number
    3007284313-2019-00284
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    August 19, 2019
    Report Date
    October 23, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITION H6: CODE 213-THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITION H6: CODE 22-THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, UNDER ADVERSE EVENTS STATES, TRAUMA TO THE VESSEL WALL, INCLUDING RUPTURE.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K172567.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH GORE® MOLDING & OCCLUSION BALLOON FOR ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD PRE-EXISTING LOCALIZED DISSECTIONS IN BOTH THE EXTERNAL ILIAC ARTERIES. IT WAS REPORT THAT AFTER DEPLOYMENT OF GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS AND CONTRALATERAL LEG ENDOPROSTHESIS, AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED PROXIMALLY. TOUCH UP BALLOONING WAS THEN PERFORMED. IT WAS REPORTED THAT THE CONTRAST MEDIUM HAD FLOWED OUT OF THE BLOOD VESSEL FROM THE PROXIMAL NECK, THE AORTIC ARTERY HAD RUPTURED AT THIS AREA. TO TREAT THE RUPTURE, FOUR AORTIC EXTENDER ENDOPROSTHESES WERE DEPLOYED ON THE PROXIMAL SIDE. THE OUTFLOW OF CONTRAST MEDIUM DISAPPEARED. AFTER ANGIOGRAPHY, THE BLOOD FLOW TO THE LEFT INTERNAL ILIAC ARTERY WAS NOT CONFIRMED. THE POSSIBILITY OF OCCLUSION OF EFFECTS DUE TO THROMBOSIS WAS REPORTED. SINCE BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY WAS CONFIRMED, THE PHYSICIAN CHOSE TO MONITOR THE LEFT INTERNAL ILIAC ARTERY OCCLUSION. DURING CLOSURE OF WOUND, THE PULSE IN DISTAL OF RIGHT LEG WAS WEAK. WHEN ANGIOGRAPHY WAS PERFORMED, A DISSECTION APPEARED TO HAVE OCCURRED ON THE DISTAL SIDE OF THE STENT GRAFT, AND BLOOD FLOW IN THE RIGHT INTERNAL ILIAC ARTERY COULD NOT BE CONFIRMED. IT IS UNKNOWN IF THE IMPLANTED DEVICE OR THE DRYSEAL FLEX SHEATH WAS RESPONSIBLE FOR THE ADDITIONAL DISSECTION IN THE RIGHT ILIAC ARTERY. IN ADDITION, ANGIOGRAPHY TO BELOW THE KNEE WAS PERFORMED, THE OCCLUSION WAS CONFIRMED. TWO BARE METAL STENTS WERE IMPLANTED FROM THE DISTAL SIDE OF THE STENT GRAFT TO THE RIGHT EXTERNAL ILIAC ARTERY. AFTER PTA BALLOONING AND PASSING WIRE AND MICRO CATHETER BELOW THE KNEE, A SLIGHT BLOOD FLOW WAS CONFIRMED. THE DOCTOR STATED "THE NO BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY MIGHT BE DUE TO THE DISSECTION." THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866391 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20549753 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization