BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TRI-LOBE BALLOON CATHETER

    MDR report key: 5513809 · Received March 21, 2016

    Report

    Report Number
    3007284313-2016-00035
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    March 12, 2016
    Report Date
    March 12, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICATIONS INCLUDE: ASPIRIN, VITAMIN D, NORCO, TOPROL, SYNTHROID AND OXYCONTIN. (B)(4). THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® TRI-LOBE BALLOON CATHETER INSTRUCTIONS FOR USE ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE, ANEURYSM RUPTURE AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF AN ACUTE TYPE B DISSECTION AND CONTAINED RUPTURE OF THE THORACIC AORTA WITH THREE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. INTRA-OPERATIVE ANGIOGRAPHY IDENTIFIED THE PRIMARY ENTRY TEAR ~1 CM DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA). REPORTEDLY, IN AN EFFORT TO OBTAIN AN ADDITIONAL 1.5 CM OF SEAL, THE PHYSICIAN ELECTED TO IMPLANT THE TAG DEVICE (TGU343415) DISTAL TO THE LEFT COMMON CAROTID ARTERY (LCCA) WITH INTENTIONAL COVERAGE OF THE LSA. ADDITIONALLY, TO ADDRESS THE RUPTURE, THE PHYSICIAN PLANNED TO COVER THE DESCENDING AORTA DISTALLY FROM THE LCCA TO THE CELIAC ARTERY. THE TOTAL COVERAGE LENGTH WAS REPORTED TO BE ~230MM, REPORTEDLY THE ENTIRE DISSECTION WAS COVERED. FIRST, A TAG DEVICE (TGU454515) WAS IMPLANTED DISTALLY, THEN THE TAG DEVICE (TGU343415) WAS IMPLANTED IN THE MOST PROXIMAL POSITION. FINALLY, AN ADDITIONAL TAG DEVICE (TGU454510) WAS IMPLANTED AS A BRIDGE BETWEEN THE TWO DEVICES. REPORTEDLY, SUFFICIENT OVERLAP WAS OBTAINED, WITH A REPORTED 4-5 CM OVERLAP BETWEEN ALL DEVICES. REPORTEDLY, TOUCH UP BALLOONING WAS PERFORMED WITHIN THE OVERLAP AREAS UTILIZING A GORE TRI-LOBE BALLOON CATHETER (BCL2645) ACCORDING TO STANDARD PROTOCOL AND IN AN UNHURRIED FASHION. IT WAS REPORTED THAT DURING BALLOONING THE SEPTUM RUPTURED RESULTING IN A NOTICEABLE DROP IN THE PATIENT'S BLOOD PRESSURE. MEDICATION WAS ADMINISTERED AND THE PATIENT RECOVERED. HOWEVER, DURING FINAL BALLOONING REPORTEDLY THE PATIENT'S BLOOD PRESSURE KEPT DROPPING AND REBOUNDING. IMAGING WAS AGAIN PERFORMED AND BLOOD FLOW WAS SEEN AT THE PROXIMAL END OF THE TAG DEVICE (TGU343415). IT WAS REPORTED, THE BLOOD FLOW CONTINUED PAST THE GRAFT AND INTO THE LSA WITH PERSISTENT FILLING OF THE PRIMARY ENTRY TEAR. TO ADDRESS THE ISSUE, THE PHYSICIAN ELECTED TO PLACE A 14 MM AMPLATZER PLUG INTO THE LSA. REPORTEDLY, AT THIS POINT IN THE PROCEDURE THE PATIENT WENT INTO ACUTE CARDIAC ARREST AND ASYSTOLE. CHEST COMPRESSIONS WERE PERFORMED AND SIX UNITS OF BLOOD PRODUCTS WERE ADMINISTERED. HOWEVER, AFTER 20 MINUTES OF CONTINUED CARDIOPULMONARY RESUSCITATION (CPR) IT WAS REPORTED THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169157 GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 13945720

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death