GORE® EXCLUDER® AAA ENDOPROSTHESIS
Report
- Report Number
- 3013164176-2025-02702
- Event Type
- Injury
- Date Received
- October 7, 2025
- Date of Event
- May 23, 2025
- Report Date
- January 7, 2026
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDED B2, B5, G3/G4, H1/H2, H3, H6. H1: THIS EVENT WILL REMAIN CLASSIFIED AS A REPORTABLE SERIOUS INJURY RATHER THAN A DEVICE-RELATED DEATH. THE CELIAC ARTERY DISSECTION WAS ATTRIBUTED TO A NON-GORE DEVICE DURING GUIDEWIRE CANNULATION. ADDITIONALLY, NO EVIDENCE SUGGESTS THAT ANY GORE DEVICE CAUSED OR CONTRIBUTED TO THE LIVER SHOCK THAT SUBSEQUENTLY RESULTED IN DEATH. THE DEVICE EVALUATION DETERMINED THE FOLLOWING: SUBMITTED IN FORMALIN SOAKED TOWELS WERE SIX FREE FLOATING TISSUE FRAGMENTS (TF-1-6), ONE SEPARATE GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (CELIAC SBC-2), AND A SPECIMEN CONSISTING OF TWO NON-GORE DEVICES (PRESUMED TERUMO RELAY PLUS THORACIC STENT GRAFTS [TRP-1 & -2]) AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES SYSTEM (TAMBE SYSTEM); FOUR GORE® EXCLUDER®, ONE GORE® TAG®, AND EIGHT GORE® VIABAHN® ENDOPROSTHESIS COMPONENTS: ONE CTAG AORTIC COMPONENT ¿ GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTORL SYSTEM (CTAG-AC), ONE AORTIC COMPONENT ¿ GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (AC), EIGHT SIDE BRANCH COMPONENTS ¿ GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESES; TWO COMPONENTS IN THE RIGHT RENAL (RR SBC-1 & -2), TWO COMPONENTS IN THE SUPERIOR MESENTERIC (SMA SBC-1 & -2), ONE COMPONENT IN THE CELIAC (CELIAC SBC-1), AND TWO COMPONENTS IN THE LEFT RENAL (LR SBC-1 & -2), ONE ILIAC BRANCH COMPONENT ¿ GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), AND TWO CONTRALATERAL LIMB EXTENDERS ¿ GORE® EXCLUDER® AAA ENDOPROSTHESES (CL-1 & -2). THE FREE FLOATING TISSUE FRAGMENTS WERE OF VARYING SIZES AND IRREGULARLY SHAPED. FOUR OF THE FRAGMENTS (TF-1-4) CONSISTED OF SEMI-FRIABLE DARK RED TO DARK BROWN MATERIAL, CONSISTENT WITH COAGULATED BLOOD. THE REMAINING TWO FRAGMENTS (TF-5-6) CONSISTED OF SHEETS OF FRIABLE MOTTLED TAN TO SEMI-OPAQUE MEMBRANES, CONSISTENT WITH THE TISSUE FOUND LINING THE LUMINAL SURFACE OF TRP-1. THE ABLUMEN OF THE SEPARATE CELIAC SBC-2 WAS GENERALLY DEVOID OF TISSUE EXCEPT FOR SCATTERED PLAQUES OF SEMI FRIABLE DARK BROWN MATERIAL (COAGULATED BLOOD). THE DEVICE WAS IRREGULARLY CONTOURED WITH AREAS OF FLATTENING AND FOLDING ALONG THE LENGTH. THE TIME AND/OR CAUSE (E.G., IN VIVO OR DURING POST-MORTEM REMOVAL) OF THESE IRREGULAR CONTOURS ARE UNABLE TO BE ASSESSED. THE ABLUMEN OF THE SPECIMEN CONSISTING OF TWO NON-GORE DEVICES (TRP-1-2) AND A TAMBE SYSTEM WAS GENERALLY DEVOID OF TISSUE EXPECT FOR SCATTERED PLAQUES OF SEMI-FRIABLE RED TO BROWN MATERIAL (COAGULATED BLOOD). THE LUMEN OF THE PROXIMAL END OF TRP-1 WAS WIDELY PATENT WITH A CIRCUMFERENTIAL FRIABLE MOTTLED TAN TO SEMI-OPAQUE MEMBRANE LINING THE LUMINAL SURFACE. AN 6MM TRANSECTION WAS PRESENT AT THE PROXIMAL END OF THE MOST PROXIMAL NON-GORE DEVICE (TRP-1). THE LUMENS OF BOTH CL-1 & -2 WERE WIDELY PATENT AND PARTIALLY LINED WITH DARK RED FRIABLE TISSUE. THE PATENCY OF THE PORTALS WAS UNABLE TO BE DETERMINED DUE TO THE PRESENCE OF DARK RED TO BROWN FRIABLE TISSUE (COAGULATED BLOOD) WITHIN THE LUMEN AT THE AC LEVEL OF THE DEVICE. THE SBCS WERE IRREGULARLY CONTOURED WITH AREAS OF FLATTENING AND KINKING ALONG THE LENGTHS. THE TIME AND/OR CAUSE (E.G., IN VIVO OR DURING POST-MORTEM REMOVAL) OF THESE IRREGULAR CONTOURS ARE UNABLE TO BE ASSESSED. THE PATENCY OF THE SBCS WAS UNABLE TO BE DETERMINED DUE TO THE COMPRESSED STATE OF DEVICES AS RECEIVED. HISTOPATHOLOGIC ANALYSIS WAS NOT PERFORMED, DUE TO THE LACK OF ADHERENT TISSUE. THE DEVICES WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION, ALL DEVICES WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. NO WEAR RELATED DISRUPTIONS WERE IDENTIFIED.
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.
THE FOLLOWING INFORMATION WAS REPORTED FROM THE AAA24-01 CLINICAL STUDY MANAGER: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE MAXIMUM DIAMETER OF THE AORTIC DISEASE WAS 67MM. THE PATIENT'S CELIAC ARTERY WAS NOTED AS STENOSED DURING CASE PLANNING PRIOR TO THE PROCEDURE. THE DIAMETER OF THE PATIENT'S CELIAC ARTERY 15MM DISTAL TO THE OSTIUM WAS 8MM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT WERE USED IN THE PATIENT'S AORTA WITH THE TAMBE DEVICE. GORE® EXCLUDER AAA ENDOPROSTHESES WERE USED IN THE PATIENT'S ILIAC ARTERY. IT WAS REPORTED THAT, DURING GUIDEWIRE CANNULATION OF THE CELIAC ARTERY, THE PATIENT EXPERIENCED A CELIAC ARTERY DISSECTION AND SPLENIC ARTERY RUPTURE. TWO PLANNED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE PATIENT'S CELIAC ARTERY. AN UNPLANNED GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS IMPLANTED IN THE SPLENIC ARTERY TO TREAT THE RUPTURE. ULTIMATELY A SPLENECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED COMPLICATIONS POST PROCEDURE, INCLUDING LIVER SHOCK. SPINAL CORD ISCHEMIA (SCI) WAS ALSO OBSERVED ON (B)(6) 2025. AN EMERGENT LUMBAR DRAIN WAS PLACED ON THE SAME DAY TO TREAT THE SCI. NEUROLOGICAL DEFICITS RELATED TO THE SCI WERE NOTED, INCLUDING PARALYSIS. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND WAS PLACED ON COMFORT CARE. ON (B)(6) 2025, THE PATIENT EXPIRED. THE OFFICIAL CAUSE OF DEATH WAS DETERMINED TO BE SHOCK LIVER SECONDARY TO BLEEDING, WHICH LED TO DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND ULTIMATELY MULTI-SYSTEM ORGAN FAILURE. IT WAS CONCLUDED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE SYSTEM. DURING THE AUTOPSY ON (B)(6) 2025, THE SITE EXPLANTED THE TAMBE DEVICE SYSTEM. THE EXPLANTED DEVICE SYSTEM WAS RETURNED. IT WAS NOTED THAT THE DEVICE EXPLANT WAS NOT REPORTEDLY RELATED TO AN ALLEGATION AGAINST THE DEVICE SYSTEM, BUT THAT THE EXPLANT WAS PERFORMED DURING THE ALREADY PLANNED AUTOPSY PROCEDURE.
THE FOLLOWING INFORMATION WAS REPORTED FROM THE AAA24-01 CLINICAL STUDY MANAGER: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE MAXIMUM DIAMETER OF THE AORTIC DISEASE WAS 67MM. THE PATIENT'S CELIAC ARTERY WAS NOTED AS STENOSED DURING CASE PLANNING PRIOR TO THE PROCEDURE. THE DIAMETER OF THE PATIENT'S CELIAC ARTERY 15MM DISTAL TO THE OSTIUM WAS 8MM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT WERE USED IN THE PATIENT'S AORTA WITH THE TAMBE DEVICE. GORE® EXCLUDER AAA ENDOPROSTHESES WERE USED IN THE PATIENT'S ILIAC ARTERY. IT WAS REPORTED THAT, DURING GUIDEWIRE CANNULATION OF THE CELIAC ARTERY, THE PATIENT EXPERIENCED A CELIAC ARTERY DISSECTION AND SPLENIC ARTERY RUPTURE. TWO PLANNED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE PATIENT'S CELIAC ARTERY. AN UNPLANNED GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS IMPLANTED IN THE SPLENIC ARTERY TO TREAT THE RUPTURE. ULTIMATELY A SPLENECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED COMPLICATIONS POST PROCEDURE, INCLUDING LIVER SHOCK. SPINAL CORD ISCHEMIA (SCI) WAS ALSO OBSERVED ON (B)(6) 2025. AN EMERGENT LUMBAR DRAIN WAS PLACED ON THE SAME DAY TO TREAT THE SCI. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND WAS PLACED ON COMFORT CARE. ON (B)(6) 2025, THE PATIENT EXPIRED. DURING THE AUTOPSY ON (B)(6), 2025, THE SITE EXPLANTED THE TAMBE DEVICE SYSTEM. THE EXPLANTED DEVICE SYSTEM WAS RETURNED. IT WAS NOTED THAT THE DEVICE EXPLANT WAS NOT REPORTEDLY RELATED TO AN ALLEGATION AGAINST THE DEVICE SYSTEM, BUT THAT THE EXPLANT WAS PERFORMED DURING THE ALREADY PLANNED AUTOPSY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2746340 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention| H |