BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    MDR report key: 24856242 · Received April 13, 2026

    Report

    Report Number
    2017233-2026-07364
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 27, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    QZK
    UDI-DI
    00733132662357
    PMA / PMN Number
    P230023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS AND CONCLUSIONS WERE UPDATED TO REFLECT THE RESULTS OF INVESTIGATION. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS USED AS BRANCH COMPONENTS. GORE® DRYSEAL FLEX INTRODUCER SHEATH, GORE® MOLDING & OCCLUSION BALLOON CATHETER, AND GORE® TRI LUMEN CATHETER WERE CONCOMITANTLY USED AS ACCESSORY DEVICES. DURING THE PROCEDURE, ACCESS TO THE LEFT RENAL ARTERY WAS CONSIDERABLY MORE DIFFICULT THAN THAT TO THE OTHER BRANCHES DUE TO PATIENT¿S ANATOMICAL FACTOR. THE PATIENT HAD STENOSIS CAUSED BY PRE-EXISTING DISSECTION OF THE LEFT RENAL ARTERY, RESULTING IN A TENDENCY FOR GUIDEWIRES AND CATHETERS TO PROLAPSE BACK INTO THE AORTA. BECAUSE ADEQUATE SUPPORT COULD NOT BE OBTAINED FROM THE UPPER-EXTREMITY APPROACH ALONE, ADDITIONAL ACCESS FROM THE FEMORAL ARTERY WAS ATTEMPTED, BUT THE ACCESS FROM THE LEFT FEMORAL ARTERY WAS NOT SUCCEEDED. AFTER THAT, A SNARE CATHETER INSERTED FROM THE RIGHT FEMORAL ARTERY THROUGH A 22 FR SHEATH CAPTURED THE GUIDEWIRE FROM THE UPPER-EXTREMITY ACCESS, ALLOWING ADVANCEMENT INTO THE RENAL ARTERY. A VBX DEVICE WAS INTRODUCED INTO THE RENAL ARTERY; HOWEVER, IT BECAME UNSTABLE DUE TO LIMITED WIRE SUPPORT. BALLOON-ASSISTED STABILIZATION WAS ATTEMPTED FROM THE FEMORAL APPROACH BUT WAS INEFFECTIVE. THE VBX DEVICE WAS EXPANDED TO NOMINAL DIAMETER; HOWEVER, DURING THE DEFLATION OF THE BALLOON, THE STENT GRAFT PROLAPSED INTO THE AORTA FROM THE LEFT RENAL ARTERY. ANOTHER SNARE-ASSISTED ACCESS TO THE LEFT RENAL ARTERY WAS REPEATED AND A SECOND VBX DEVICE WAS SUCCESSFULLY DEPLOYED IN THE LEFT RENAL ARTERY. AFTER COMPLETION OF IMPLANTATION OF ALL THE BRANCH COMPONENTS, MOTOR EVOKED POTENTIAL (MEP) MONITORING SHOWED A TRANSIENT DECREASE IN RESPONSE IN THE RIGHT LOWER LIMB. IT WAS CONSIDERED DUE TO PROLONGED SHEATH INSERTION (TOTAL OPERATING TIME AT THIS POINT WAS APPROXIMATELY 4 AND HALF HOURS); THEREFORE, DEPLOYMENT OF DISTAL BIFURCATED COMPONENT AND CONTRALATERAL LEG COMPONENT WAS DETERMINED TO BE POSTPONED FOR A LATER DATE. DURING THE SURGICAL WOUND CLOSURE, DECREASED PULSATION OF THE LEFT LOWER LIMB WAS NOTED. SUBSEQUENT ANGIOGRAPHY SHOWED OCCLUSION OF THE POPLITEAL ARTERY. THROMBECTOMY WAS PERFORMED USING A FOGARTY CATHETER, RESULTING IN RESTORATION OF BLOOD FLOW. AFTER PATIENT AWAKENED, MOTOR FUNCTION OF BOTH LOWER LIMBS WAS CONFIRMED TO BE INTACT, INDICATING NO RESIDUAL NEUROLOGICAL DEFICIT. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE THROMBOEMBOLIC EVENT OF THE LEFT LOWER LIMB WAS LIKELY CAUSED BY THROMBUS MIGRATION DURING RECONSTRUCTION OF THE LEFT RENAL ARTERY. COMPARED WITH THE OTHER BRANCH RECONSTRUCTIONS, THE LEFT RENAL ARTERY REQUIRED A PROLONGED PROCEDURE TIME AND INVOLVED IRREGULAR AND COMPLEX PROCEDURAL STEPS. HOWEVER, THE SPECIFIC TIMING OF THROMBUS MIGRATION WAS UNKNOWN. ALL DEVICES USED FOR THE LEFT RENAL ARTERY HAD A POSSIBILITY CAUSING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513276 GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO QZK W. L. GORE & ASSOCIATES, INC. 00733132662357

    Patients

    Seq Age Sex Outcome Treatment
    1