BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 21588035 · Received March 12, 2025

    Report

    Report Number
    2017233-2025-05927
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 3, 2025
    Report Date
    May 28, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., PARAPARESIS, NUMBNESS, SPINAL CORD ISCHEMIA) 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

    CORRECTION TO SECTION D.

    Description of Event or Problem · 0

    SUKGU M. HAN, IMANI MCELROY, GUSTAVO S. ODERICH, DOUBLE PRELOADED INTERNAL UP-AND-OVER TECHNIQUE FOR TOTAL TRANSFEMORAL FOUR VESSEL THORACOABDOMINAL MULTIBRANCH ENDOPROSTHESIS WITH TEMPORARY AORTIC BALLOON OCCLUSION FOR RUPTURED COMPLEX ABDOMINAL AORTIC ANEURYSM, JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, VOLUME 11, ISSUE 2, 2025, 101737, ISSN 2468-4287. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101737. HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S246842872500019X. SUMMARY: THIS REPORT DESCRIBES A MODIFIED INTERNAL UP-AND-OVER TOTAL TRANSFEMORAL TAMBE [GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS] TECHNIQUE, WHICH LEVERAGES A CONTRALATERAL TRANSFEMORAL APPROACH FOR TEMPORARY AORTIC OCCLUSION BALLOON FOR AORTIC CONTROL IN THE CONTEXT OF A RUPTURED COMPLEX AAA [AORTIC ABDOMINAL ANEURYSM]. A (B)(6) WOMAN PRESENTED WITH SUDDEN ABDOMINAL PAIN AND TENDERNESS OVER A PULSATILE MASS. A COMPUTED TOMOGRAPHY [CT] SCAN REVEALED A 10-CM ANGULATED COMPLEX AAA. ON THE MORNING OF THE PLANNED REPAIR, THE PATIENT EXPERIENCED SEVERE DETERIORATION OF THE ABDOMINAL AND BACK PAIN, THEN BECAME UNRESPONSIVE AND HYPOTENSIVE WITH A SYSTOLIC PRESSURE OF 70 MM HG. EMERGENT INTUBATION WAS PERFORMED, FOLLOWED BY ENDOVASCULAR REPAIR USING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS DEVICE. BILATERAL PERCUTANEOUS FEMORAL ACCESS WAS ACHIEVED WITH SHEATHS IN THE RIGHT AND LEFT FEMORAL ARTERIES. THROUGH THE LEFT SHEATH, A CODA OCCLUSION BALLOON (COOK MEDICAL, BLOOMINGTON, IN) WAS PLACED FOR TEMPORARY AORTIC OCCLUSION IN THE DISTAL DESCENDING THORACIC AORTA FOR POTENTIAL HEMORRHAGE CONTROL. THE PATIENT¿S SYSTOLIC BLOOD PRESSURE REMAINED ABOVE 80 MM HG WITH ONGOING RESUSCITATION, BALLOON OCCLUSION WAS NOT NECESSARY. THE TAMBE MAIN BODY WAS PREPARED ON THE BACK TABLE BY REVERSE-LOADING EACH WIRE THROUGH THE RENAL AND VISCERAL PORTALS. THE TAMBE DEVICE WAS INTRODUCED VIA THE 22F SHEATH AND FULLY DEPLOYED IN THE SUPRA-CELIAC AORTA. THE DELIVERY SYSTEM WAS REMOVED. USING THE CONTRALATERAL FEMORAL APPROACH THE TAMBE DEVICE WAS CATHETERIZED. USING THE IPSILATERAL PRELOADED WIRES, AN 8.5F 55 CM STEERABLE SHEATH WAS ADVANCED OVER A PRELOADED WIRE THROUGH THE LEFT RENAL PORTAL INTO THE TAMBE MAIN BODY. THE STEERABLE SHEATH WAS GUIDED THROUGH THE CELIAC PORTAL. THE BRIDGING CELIAC STENT (GORE®.VIABAHN®.VBX BALLOON EXPANDABLE ENDOPROSTHESIS, W. L. GORE & ASSOCIATES) WAS DEPLOYED. A NEW THROUGH-AND-THROUGH WIRE WAS ACHIEVED WITH AN ENDOVASCULAR SNARE INTRODUCED THROUGH THE IPSILATERAL SHEATH. THE 8F STEERABLE SHEATH WAS THEN LOADED ONTO THE OTHER END OF THE THROUGH-AND-THROUGH WIRE TO ACCESS THE LEFT RENAL PORTAL. THE BRIDGING RENAL STENTS, (BOTH VBX DEVICES), WERE DEPLOYED. THE SAME STEPS WERE REPEATED FOR THE SUPERIOR MESENTERIC ARTERY AND THE RIGHT RENAL ARTERY. TO SECURE THE DISTAL SEAL AT THE TAPERED AORTIC BIFURCATION, GORE®.TAG®. CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES WERE INITIALLY USED, BUT OWING TO CRANIAL MIGRATION, A BIFURCATED ENDOVASCULAR AORTIC REPAIR DEVICE (GORE®.EXCLUDER®.AAA ENDOPROSTHESIS) WAS USED TO COMPLETE THE REPAIR. A CT SCAN CONFIRMED NO TYPE I OR III ENDOLEAKS. THE PATIENT DEVELOPED SPINAL CORD ISCHEMIA ON DAY 2, WHICH WAS MANAGED WITH A LUMBAR DRAIN, LEADING TO RESTORED MOTOR FUNCTION BY DAY 5, AND DISCHARGE FROM THE HOSPITAL ON POSTOPERATIVE DAY 11. POSTOPERATIVE CT ANGIOGRAPHY SHOWED SUCCESSFUL ANEURYSM EXCLUSION WITH PATENT VISCERAL AND RENAL BRANCHES, AS WELL AS PERIAORTIC HEMATOMA CONSISTENT WITH INTERVAL DEVELOPMENT OF CONTAINED RUPTURE IMMEDIATELY BEFORE THE OPERATION. THE DOUBLE PRELOADED UP-AND-OVER TECHNIQUE FACILITATES TOTAL TRANSFEMORAL TAMBE IMPLANTATION AND IS PARTICULARLY ADVANTAGEOUS IN EMERGENT REPAIRS OF RUPTURED PARARENAL AND THORACOABDOMINAL AORTIC ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616008 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention