BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 19660647 · Received July 2, 2024

    Report

    Report Number
    2017233-2024-05084
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132659685
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: HTN, HYPERCHOLESTEROEMIA, SLEEP APNEA, HISTOR OF TIA. D10: PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: AMLODIPINE, ATORVASTATIN, FLEXERIL, LOSARTAN, METOPROLOL SUCCINATE ER, NAPROXDN TABLET, SPIRONOLACTONE, TADALAFIL W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    G4: ADDED PMA. H6: ADDITIONAL CODES. THE INSTRUCTIONS FOR USE FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS STATES: POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: DISSECTION, PERFORATION, OR RUPTURE OF THE AORTIC VESSEL AND SURROUNDING VASCULATURE, REOPERATION / REINTERVENTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT DURING IMPLANT OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT THE DEVICE WAS ALMOST COMPLETELY PULLED OUT OF THE 3CM OVERLAP ZONE DURING REMOVAL OF THE DEVICE DELIVERY SYSTEM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO BRIDGE ANY GAP AND RELINE THE AREA. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED AS BRANCH DEVICES IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, RIGHT AND LEFT RENAL ARTERIES. A GORE® TRI LUMEN CATHETER WAS USED TO GAIN THROUGH AND THROUGH WIRE ACCESS TO THE BRANCH ARTERIES. THE PROCEDURE WAS COMPLETED WITH GOOD TECHNICAL RESULTS. THE PATIENT TOLERATED THE PROCEDURE. ON JUNE 26, 2024, IT WAS REPORTED THAT THE PATIENT AWOKE AND HAD NO FEELING IN HIS LEGS. THE PATIENT UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PARAPLEGIA. THE PATIENT IS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO HAVE STARTED REGAINING MOVEMENT IN HIS RIGHT LEG AND CAN MOVE HIS LEFT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800993 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132659685

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other| H