BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 20006246 · Received August 20, 2024

    Report

    Report Number
    2017233-2024-05232
    Event Type
    Death
    Date Received
    August 20, 2024
    Date of Event
    July 29, 2024
    Report Date
    January 16, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132659678
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3: CORRECTED DATE.

    Additional Manufacturer Narrative · 0

    PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: ATRIAL FIBRILLATION, PMH OF COPD, DIABETES MELLITUS, EXERCISE INTOLERANCE, HYPERLIPIDEMIA, HYPERTENSION, OBESITY, PULMONARY HYPERTENSION, AAA, FORMER SMOKER. PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: ALBUTEROL, NORBASC, TRELEGY ELLIPTA, LOPRESSOR, XARELTO, CRESTOR, OZEMPIC, DIOVAN-HCT. 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 HAVE NOT 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

    H6: ADDED RESULT CODE.

    Additional Manufacturer Narrative · 0

    B2, H1/H2: CORRECTED INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 ABDOMINAL AORTIC ANEURYSM. THE PATIENT¿S IS REPORTED TO HAVE A PRE-EXISTING AAA S/P Y-GRAFT WHICH WAS IMPLANTED IN 2004. PRESENTLY, THE PHYSICIAN REPORTS THE ANEURYSM HAS DILATED TO 4.65CM WITH DILATION OF THE SUPRARENAL ARTERY MEASURING 5CM AND AN AREA AT THE RENAL ARTERIES THAT BLOSSOMS OUT TO APPROXIMATELY 9CM. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® ABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE COMPLETE TAMBE SYSTEM IS COMPRISED OF THE TAMBE AORTIC COMPONENT, THE BRANCH COMPONENTS (GORE® VIABAHN® (VBX) BALLOON EXPANDABLE ENDOPROSTHESIS), A DISTAL BIFURCATED COMPONENT (GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT) AND CONTRALATERAL LEGS (GORE® EXCLUDER® CONTRALATERAL LEGS). IT WAS REPORTED THAT ALL PROXIMAL AND BRANCH DEVICES HAD BEEN SUCCESSFULLY DEPLOYED AS INTENDED WITH TECHNICAL SUCCESS (WITH EXCEPTION OF THE FINAL BRANCH DEVICE WHICH WAS ADVANCED BUT NOT YET DEPLOYED). IT WAS REPORTED THAT UPON DEPLOYMENT OF THE DISTAL END OF THE TAMBE AORTIC COMPONENT, THE VBX¿S DEPLOYED IN THE RIGHT RENAL ARTERY BECAME DISLODGED FROM THE RIGHT RENAL ARTERY PORTAL OF THE AORTIC COMPONENT AND CREATED A LEAK. MULTIPLE ATTEMPTS TO REGAIN PURCHASE WITHIN THE PORTAL AND RIGHT RENAL ARTERY WERE MADE WITH AN ADDITIONAL VBX BUT WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE INITIAL DEPLOYMENT WITHIN THE RIGHT PORTAL/RENAL ARTERY HAD BEEN SUCCESSFUL WITH A GOOD 3CM PURCHASE. IT IS BELIEVED THAT A CRISSCROSS OF WIRES MAY HAVE CONTRIBUTED TO THE DISLODGEMENT OF THE VBX FROM THE RIGHT RENAL ARTERY AND PORTAL. DUE TO THE LENGTH OF THE PROCEDURE (11.5 HOURS), EXTRA OF TIME UNDER GENERAL ANESTHESIA, (294 MINUTES) OF FLUOROSCOPY AND 494 CC¿S OF CONTRAST THE PHYSICIAN CHOSE TO PLUG THE RIGHT RENAL PORTAL WITH A 12MM AMPLATZER PLUG AND CONCLUDE THE PROCEDURE. POST OPERATIVELY THE PATIENT WAS INTUBATED AND BECAME ACIDOTIC, AND SLOWLY BEGAN TO EXPERIENCE MULTI ORGAN FAILURE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2024. AN OFFICIAL CAUSE OF DEATH WAS NOT AVAILABLE BUT WAS THOUGHT TO HAVE BEEN DUE TO A CARDIAC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349880 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132659678

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other| H| D