BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TRI-LOBE BALLOON CATHETER

    MDR report key: 11373586 · Received February 24, 2021

    Report

    Report Number
    3007284313-2021-01263
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 10, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4 510K NUMBER ADDED: K081799. H6 COMPONENT CODE ADDED: 419, BALLOON.

    Additional Manufacturer Narrative · 0

    H6: CODE 213 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE 22 ¿ ACCORDING TO THE GORE® TRI-LOBE BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS WITH MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDING, BUT NOT LIMITED TO, VASCULAR TRAUMA.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC CHRONIC TYPE B DISSECTION USING GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS. THE PRIMARY ENTRY WAS AT BELOW THE LEFT SUBCLAVIAN ARTERY. THE TGU404015J WAS IMPLANTED FROM THE LEFT COMMON CAROTID ARTERY AND TGU454520J WAS IMPLANTED DISTALLY. THE BALLOONING WAS PERFORMED TO THE DISTAL OF THE TGU454520J (INSIDE OF THE TGU454520J) USING GORE® TRI-LOBE BALLOON CATHETER IN ORDER TO PUSH THE FALSE LUMEN. AFTER ABOUT 10 MINUTES LATER, THE TGU454520J WAS MORE EXPANDED AND THE DISSECTION OCCURRED AT THE DISTAL END OF THE TGU454520J (D-SINE). DUE TO THIS DISSECTION, THE TRUE LUMEN OF MORE DISTALLY OF THE TGU454520J BECAME NARROW. A STENT WAS IMPLANTED IN THE SUPERFICIAL MESENTERIC ARTERY AND THEN, A NON-GORE STENT (AFX WITHOUT THE GRAFT) WAS IMPLANTED FROM WITHIN THE GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS TO THE MIDDLE OF THE ABDOMINAL AORTA. IT WAS OBSERVED BY IVUS THAT NO ISSUE FOR THE BLOOD FLOW OF THE ABDOMINAL AND NO STENOSIS FOR THE FALSE LUMEN. AND IT WAS CONFIRMED THAT THE TGU404015J MIGRATED ABOUT 2CM DISTALLY DUE TO THE TRUE LUMEN WAS DILATED. AND BLOOD INFLOWED INTO THE FALSE LUMEN. IT IS POSSIBLE THAT THE IT LED TO THE TRUE LUMEN EXPANDED THAT THE GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS WAS EXPANDED. THE STENT TGU404010J WAS IMPLANTED PROXIMALLY (FROM JUST BELOW THE LEFT SUBCLAVIAN ARTERY). THE PROCEDURE WAS CONCLUDED AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN SUGGESTED THE CAUSE OF THE DISSECTION THAT THE BLOOD WALL HAD PRESSURE BECAUSE THE BALLOONING WAS PERFORMED TO THE TORTUOUS SITE. REGARDING TO THE MIGRATION OF TGU404015J, THE MIGRATION MIGHT HAVE BEEN CAUSED THAT THERE WAS THE FALSE LUMEN AT THE GREATER CURVATURE SIDE AND THE WALL BETWEEN FALSE LUMEN AND THE TRUE LUMEN MIGHT HAD BEEN SOFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270144 GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention