BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8958111 · Received September 3, 2019

    Report

    Report Number
    3007284313-2019-00269
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 4, 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

    H.6. RESULTS CODE 1 UPDATED. H.6. RESULTS CODE 1: CODE 213 ¿ THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. CONCLUSIONS CODE 1 UPDATED. H.6. CONCLUSION CODE 2: CODE 22 - ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, TRAUMA TO THE VESSEL WALL SUCH AS PERFORATION OR RUPTURE. FURTHERMORE, THE IFU CAUTIONS USERS TO NOT INFLATE THE BALLOON TO A DIAMETER LARGER THAN THE VESSEL IT IS BEING INFLATED WITHIN. TO AVOID VESSEL TRAUMA, DO NOT OVER-INFLATE THE BALLOON IN RELATION TO THE DIAMETER OF THE VESSEL OR OTHER DEVICES.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K172567.

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND A LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES, AND A GORE MOLDING AND OCCLUSION BALLOON CATHETER. IT WAS REPORTED THAT THE PATIENT HAD A PRE-EXISTING DISSECTION IN THE RIGHT COMMON ILIAC ARTERY. PRIOR TO IMPLANT OF THE GORE EXCLUDER AAA ENDOPROSTHESES, THE PATIENT'S INFERIOR MESENTERIC ARTERY AND LEFT INTERNAL ILIAC ARTERY WERE INTENTIONALLY COIL EMBOLIZED. AFTER DEPLOYMENT OF THE GORE EXCLUDER AAA ENDOPROSTHESES, N-BUTYL-2-CYANOARYLATE (NBCA) WAS INJECTED INTO THE PATIENT'S ABDOMINAL AORTIC ANEURYSM SAC THROUGH A KMP CATHETER THAT HAD BEEN INSERTED FROM THE PATIENT'S RIGHT ACCESS SITE. THE PHYSICIAN PULLED THE KMP CATHETER TO INJECT NBCA INTO THE DISSECTION SITE IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. NBCA WAS NOTED FLOWING DISTALLY FROM THE DISSECTION SITE. A GORE MOLDING AND OCCLUSION BALLOON CATHETER (MOB) WAS INSERTED INTO THE CONTRALATERAL LEG COMPONENT LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN EXPANDED THE MOB CATHETER IN AN ATTEMPT TO STOP THE NBCA OUTFLOW. REPORTEDLY THE PHYSICIAN STATED THAT THE BALLOON WAS OVER-EXPANDED. THE PATIENT'S BLOOD PRESSURE DECREASED. ANGIOGRAPHY REVEALED THAT BLOOD HAD FLOWED OUT OF THE BLOOD VESSEL, AND THAT THE RIGHT EXTERNAL ILIAC ARTERY HAD RUPTURED. IT WAS NOTED THAT THE PORTION OF THE MOB CATHETER THAT PROTRUDED FROM THE CONTRALATERAL LEG COMPONENT WAS OVER-EXPANDED, AND THE VESSEL WAS RUPTURED JUST DISTAL OF THE RIGHT ILIAC ARTERY BIFURCATION. AN ILIAC EXTENDER COMPONENT WAS DEPLOYED TO EXTEND THE CONTRALATERAL LEG COMPONENT IN AN ATTEMPT TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY RUPTURE. NO OUTFLOW OF BLOOD WAS NOTED, AND THE PATIENT'S BLOOD PRESSURE STABILIZED. IT WAS NOTED THAT THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY COVERED BY THE ILIAC EXTENDER COMPONENT. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749733 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20554606 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R