GORE VIABAHN VBX Balloon Expandable Endo BXA067902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00733132637492), received between Oct 12, 2020 and Mar 24, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (9 reports).

1 other recall cover devices cleared under the same FDA submission (P160021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Complete Blockage; Biocompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT DEVELOPED ABDOMINAL PAIN THAT PROGRESSIVELY WORSENED AND WAS ACCOMPANIED BY COFFEE-GROUND EMESIS. ON (B)(6) 2026, A REPEAT CTA SHOWED INTERVAL OCCLUSION DUE TO VBX STENT THROMBOSIS OF THE CELIAC, RIGHT AND LEFT RENAL ARTERIES. THE VBX STENT IN THE SMA REMAINED PATENT AS THE SOLE MESENTERIC INFLOW. LABORATORY RESULTS ON THIS DATE SHOWED ELEVATED BUN (59 MG/DL) AND CREATININE (3.09 MG/DL). BASED ON THE CTA FINDINGS AND THE SEVERITY OF HIS ABDOMINAL PAIN, THE PATIENT WAS TAKEN EMERGENTLY FOR ENDOVASCULAR THROMBECTOMY OF THE CELIAC AND RENAL VBX DEVICES, INCLUDING THROMBUS CLEARANCE FROM THE ASSOCIATED TAMBE RENAL AND CELIAC PORTALS. ON (B)(6) 2026, ACCORDING TO THE PHYSICIAN, THE PATIENT WAS NOTED TO HAVE LOSS OF KIDNEY FUNCTION FOLLOWING THE PROCEDURE. ADDITIONALLY, THE TREATING PHYSICIAN REPORTED THE PRESENCE OF AN ACTIVE GASTRIC ULCER WITH HEMATEMESIS AND

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 24676009 ↗
• InjuryFeb 18, 2026Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT HAD A RIGHT RENAL ARTERY REINTERVENTION DUE TO 70% STENOSIS IN THE MIDDLE OF THE PREVIOUSLY IMPLANTED DEVICE. A 7X39 VBX DEVICE WAS IMPLANTED TO COVER THE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow; Stenosis

  MAUDE report 24381570 ↗
• InjuryFeb 18, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT HAD A REINTERVENTION IN THE LEFT RENAL ARTERY AS THERE WAS LACK OF PURCHASE INTO THE TAMBE PORTAL WITH THE INITIALLY IMPLANTED DEVICE. A NEW 7X5 VBX DEVICE WAS IMPLANTED DISTALLY, AND A 7X59 VBX DEVICE WAS ALSO IMPLANTED WITH PROXIMAL LANDING JUST DISTAL TO PORTAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24381258 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, A TAMBE PROCEDURE WAS PERFORMED AND THE STUDY PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® DEVICES AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. TWO OR MORE VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), LEFT RENAL ARTERY, RIGHT RENAL ARTERY, AND ONE VBX DEVICE IN CELIAC ARTERY. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO BE IN A LOCAL HOSPITAL WITH RENAL FAILURE AND IS ON DIALYSIS. NO INTERVENTION WAS REPORTED INVOLVING THE STUDY DEVICE. AS STATED, PATIENT RECORDS WERE REQUESTED. UPDATED INFORMATION STATES A NON-CONTRAST CT SCAN THAT WAS DONE AT AN OUTSIDE HOSPITAL BUT THEY COULD NOT DETERMINE ANYTHING ABOUT THE RENAL STENTS FROM THAT SCAN. THE PHYSICIAN DID NOT WANT TO GIVE PATIENT CONTRAST FOR THE CT SCAN DUE TO THE RENAL FAILURE. ULTRASOUND WAS SUGGESTED, BUT NO FURTHER INFORMATION AT THIS TIME. FIVE VBX DEVICES WERE IMPLANTED. (B)(6) RIGHT RENAL ARTERY FIRST DISTAL EXTENSION (B)(6) RIGHT RENAL ARTERY MOST PROXIMA

  Patient problems: Obstruction/Occlusion

  MAUDE report 23292566 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, A TAMBE PROCEDURE WAS PERFORMED AND THE STUDY PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® DEVICES AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. TWO OR MORE VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), LEFT RENAL ARTERY, RIGHT RENAL ARTERY, AND ONE VBX DEVICE IN CELIAC ARTERY. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO BE IN A LOCAL HOSPITAL WITH RENAL FAILURE AND IS ON DIALYSIS. NO INTERVENTION WAS REPORTED INVOLVING THE STUDY DEVICE. AS STATED, PATIENT RECORDS WERE REQUESTED. UPDATED INFORMATION STATES A NON-CONTRAST CT SCAN THAT WAS DONE AT AN OUTSIDE HOSPITAL BUT THEY COULD NOT DETERMINE ANYTHING ABOUT THE RENAL STENTS FROM THAT SCAN. THE PHYSICIAN DID NOT WANT TO GIVE PATIENT CONTRAST FOR THE CT SCAN DUE TO THE RENAL FAILURE. ULTRASOUND WAS SUGGESTED, BUT NO FURTHER INFORMATION AT THIS TIME. FIVE VBX DEVICES WERE IMPLANTED. (B)(6) RIGHT RENAL ARTERY FIRST DISTAL EXTENSION, (B)(6) RIGHT RENAL ARTERY MOST PROXIM

  Patient problems: Obstruction/Occlusion

  MAUDE report 23292128 ↗
• InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow

  A STUDY ALERT FROM THE PIVOTAL (B)(4) (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, A TAMBE PROCEDURE WAS PERFORMED AND THE STUDY PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® DEVICES AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. TWO OR MORE VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), LEFT RENAL ARTERY, RIGHT RENAL ARTERY, AND ONE VBX DEVICE IN CELIAC ARTERY. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO BE IN A LOCAL HOSPITAL WITH RENAL FAILURE AND IS ON DIALYSIS. NO INTERVENTION WAS REPORTED INVOLVING THE STUDY DEVICE. AS STATED, PATIENT RECORDS WERE REQUESTED. UPDATED INFORMATION STATES A NON-CONTRAST CT SCAN THAT WAS DONE AT AN OUTSIDE HOSPITAL BUT THEY COULD NOT DETERMINE ANYTHING ABOUT THE RENAL STENTS FROM THAT SCAN. THE PHYSICIAN DID NOT WANT TO GIVE PATIENT CONTRAST FOR THE CT SCAN DUE TO THE RENAL FAILURE. ULTRASOUND WAS SUGGESTED, BUT NO FURTHER INFORMATION AT THIS TIME. FIVE VBX DEVICES WERE IMPLANTED. (B)(6) RIGHT RENAL ARTERY FIRST DISTAL EXTENSION (B)(6) RIGHT RENAL ARTERY MOST PROXIMAL W

  Patient problems: Obstruction/Occlusion

  MAUDE report 23291614 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE ON APRIL 9, 2025, FROM THE AAA-1701 STUDY DATABASE: ON (B)(6) 2022, THIS 71-YEAR-OLD AGE FEMALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN THORACOABDOMINAL AORTIC ANEURYSM INVOLVING THE VISCERAL VESSELS. A TAMBE DEVICE WAS PLANNED FOR THIS PATIENT. THE LEFT RENAL ARTERY WAS TREATED WITH ONE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. THE PATIENT WAS TREATED WITH MULTIPLE DEVICES; ALL TAMBE SYSTEM COMPONENTS WERE SUCCESSFULLY TRACKED FROM THE ACCESS SITE TO THE INTENDED IMPLANTATION SITE AND RELEASED FROM DELIVERY CATHETERS SUCCESSFULLY. ON (B)(6) 2025, THIS PATIENT WAS NOTED TO HAVE A LEFT RENAL STENT OCCLUSION. THIS ADVERSE EVENT WAS NOTED TO BE RELATED TO THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. TREATMENT/REINTERVENTION WAS REQUIRED FOR THIS EVENT. THE TREATMENT INCLUDED LEFT RENAL ARTERY THROMBECTOMY, STENT RELINING, AND TISSUE PLASMONIGEN ACTIVATOR (TPA) FOR TOTAL OCCLUSION OF THE DEVICE. THE PATIENT WAS NOTED TO BE RECOVERED AS OF (B)(6) 2025.

  Patient problems: Stenosis

  MAUDE report 21961396 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2021, A MALE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM WHERE SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE IMPLANTED AS SIDE BRANCH DEVICES. THE VBX DEVICES WERE IMPLANTED IN SUPERIOR MESENTERIC ARTERY (SMA), CELIAC ARTERY, LEFT AND RIGHT RENAL ARTERIES. ON (B)(6) 2024, THE VBX DEVICE IN THE LEFT RENAL ARTERY HAD DISTAL EDGE STENOSIS. ON (B)(6) 2025, BALLOON ANGIOPLASTY AND IMPLANTATION OF A REDUCED PROFILE VBX DEVICE WAS PERFORMED ON THE STENOSED VBX DEVICE IN THE LEFT RENAL ARTERY. IT WAS REPORTED THE ISSUE WAS RESOLVED.

  Patient problems: Stenosis

  MAUDE report 21404586 ↗
• InjuryNov 4, 2024Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED FROM A CLINICAL STUDY: ON (B)(6) 2022, A AAA PROCEDURE WAS PERFORMED AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. THREE VBX DEVICES WERE IMPLANTED IN THE LEFT RENAL ARTERY. ON (B)(6) 2024, CTA IMAGING SHOW A TYPE 2 ENDOLEAK WITH LUMBAR ARTERY INVOLVEMENT. WHILE TREATMENT WAS PERFORMED FOR THE TYPE 2 ENDOLEAK, IT WAS NOTED AND CONFIRMED A TYPE 3 ENDOLEAK WAS PRESENT AT THE OVERLAP SITE OF THE LEFT RENAL DEVICES. ON (B)(6) 2024, AN INTERVENTION WAS PERFORMED FOR THE TYPE 3 ENDOLEAK. AN ADDITIONAL VBX DEVICE WAS IMPLANTED WITHOUT BALLOON ANGIOPLASTY. IT WAS REPORTED THE ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20603970 ↗
• InjurySep 30, 2024Complete Blockage; Patient-Device Incompatibility; Complete Blockage; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A TAMBE PROCEDURE WAS PERFORMED. AS REPORTED, THE PROCEDURE WENT AS PLANNED AND THE DEVICES WERE IMPLANTED WITH NO ISSUES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN EACH RENAL ARTERY DURING THE PROCEDURE. THE FOLLOWING DAY, FOLLOW UP CT SCAN IDENTIFIED BOTH RENAL ARTERIES WERE 'SHUT DOWN' DUE TO LACK OF PATENCY. THE VBX DEVICES WERE BOTH OCCLUDED. AS REPORTED, THE CAUSE FOR LOSS OF PATENCY IS UNCLEAR; THE VBX DEVICES WERE NOT STRUCTURALLY COMPROMISED. NO CRIMPING, NARROWING OR KINKS WERE OBSERVED FOR THE VBX DEVICES. TREATMENT TO RE-OPEN THE VBX DEVICES WAS NOT ATTEMPTED. DIALYSIS WAS PLANNED FOR THE PATIENT. THE PHYSICIAN DID STATE THERE MAY HAVE BEEN AN OUTFLOW ISSUE INVOLVING THE KIDNEYS.

  Patient problems: Renal Impairment; Thrombosis/Thrombus

  MAUDE report 20340166 ↗
• InjurySep 30, 2024Complete Blockage; Patient-Device Incompatibility; Complete Blockage; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A THORACOABDOMINAL AORTA (TAMBE) PROCEDURE WAS PERFORMED. AS REPORTED, THE PROCEDURE WENT AS PLANNED AND THE DEVICES WERE IMPLANTED WITH NO ISSUES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN EACH RENAL ARTERY DURING THE PROCEDURE. THE FOLLOWING DAY, FOLLOW UP CT SCAN IDENTIFIED BOTH RENAL ARTERIES WERE 'SHUT DOWN' DUE TO LACK OF PATENCY. THE VBX DEVICES WERE BOTH OCCLUDED. AS REPORTED, THE CAUSE FOR LOSS OF PATENCY IS UNCLEAR; THE VBX DEVICES WERE NOT STRUCTURALLY COMPROMISED. NO CRIMPING, NARROWING OR KINKS WERE OBSERVED FOR THE VBX DEVICES. TREATMENT TO RE-OPEN THE VBX DEVICES WAS NOT ATTEMPTED. DIALYSIS WAS PLANNED FOR THE PATIENT. THE PHYSICIAN DID STATE THERE MAY HAVE BEEN AN OUTFLOW ISSUE INVOLVING THE KIDNEYS.

  Patient problems: Renal Impairment; Thrombosis/Thrombus

  MAUDE report 20339078 ↗
• InjuryJul 22, 2024Obstruction of Flow; Migration; Obstruction of Flow; Migration

  INFORMATION RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2022, THE STUDY PATIENT WAS IMPLANTED WITH SEVERAL GORE® EXCLUDER® DEVICES AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE(S)) WERE ALSO IMPLANTED AS BRANCH DEVICES IN THE VISCERAL VESSELS. TWO VBX DEVICES WERE IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA), TWO VBX DEVICES IN THE CELIAC ARTERY, AND ONE VBX DEVICE IN THE LEFT RENAL ARTERY.. ON JUNE 3, 2024, GRAFT LEAKAGE WAS REPORTED FOR AN AORTIC DEVICE. AT THIS TIME, IT WAS FOUND THE VBX DEVICES LOST SEAL IN THREE VESSELS (CELIAC, SMA, AND LEFT RENAL ARTERY). AN ENDOLEAK EXTENDING FROM INFERIOR MESENTERIC ARTERY (IMA) WAS ALSO OBSERVED. IT WAS REPORTED BRANCH DEVICE PATENCY HAD BEEN LOST. ON THE SAME DAY INTERVENTION WAS PERFORMED WITH BALLOON ANGIOPLASTY AND ADDITIONAL STENTS WERE IMPLANTED IN THE THREE VESSELS. AT THE END OF PROCEDURE, THE IMA STILL HAD REMAINING ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THIS REPORT IS FOR DEVICE IMPLANTED IN THE LEFT RENAL ARTERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19801729 ↗
• InjuryNov 30, 2023Complete Blockage; Complete Blockage

  THE FOLLOWING INFORMATION WAS RECEIVED THROUGH A CLINICAL STUDY: ON DECEMBER 1, 2020, A STUDY PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE. DURING THE PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (DEVICE(S)) WERE IMPLANTED AS BRANCH DEVICES WITH TWO DEVICES OVERLAPPED IN THE CELIAC, TWO DEVICES IN SUPERIOR MESENTERIC ARTERY (SMA), AND TWO DEVICES IN RIGHT RENAL ARTERY AND ONE DEVICE IN LEFT RENAL ARTERY. DURING PATIENT'S FOLLOW-UP ON MARCH 24, 2023, THE PATIENT WAS INITIALLY DIAGNOSED WITH AN ENDOLEAK. A RIGHT RENAL ARTERY OCCLUSION WAS OBSERVED AND REPORTED AS 'STUDY DEVICE RELATED'. INTERVENTION WAS PERFORMED AND IT WAS STATED THE DEVICE WAS RECANALIZED AND ISSUE WAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18241715 ↗
• InjuryOct 30, 2023Device Stenosis; Device Stenosis

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED IN AN OVERLAPPED FASHION AS ONE UNIT IN THE LEFT RENAL ARTERY. ON (B)(6), 2021, AN ADDITIONAL VBX DEVICE (BXA067902A) WAS IMPLANTED IN THE LEFT RENAL ARTERY AS A SECOND DISTAL EXTENSION IN A POST-TREATMENT PROCEDURE. DURING PATIENT'S FOLLOW-UP ON (B)(6) 2023, IT WAS OBSERVED A STENOSIS HAD DEVELOPED AT THE EDGE OF THE VBX DEVICE IMPLANTED ON (B)(6) 2021. ON (B)(6) 2023, A BALLOON ANGIOPLASTY WITH IMPLANT OF A PERIPHERAL STENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 18030807 ↗
• InjuryFeb 27, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT A AAA PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH COMPONENTS IN THE RENAL ARTERIES. POSTOPERATIVE CT SCAN REVEALED WIDELY PATENT STENT SYSTEM. PATIENT WAS KNOWN TO HAVE A SMALL RENAL MASS ON THE LEFT KIDNEY, WHICH WAS GOING TO REQUIRE DELAYED INTERVENTION. PATIENT UNDERWENT LAPAROSCOPIC ROBOT-ASSISTED NEPHRECTOMY ON FRIDAY,(B)(6) 2022. SINCE THAT PROCEDURE THE PATIENT HAS MADE LITTLE OR NO URINE, AND WAS EMERGENTLY INITIATED ON DIALYSIS. THE DUPLEX ULTRASOUND REVEALED SOME FLOW BUT THE VELOCITIES WERE EXTREMELY LOW (ABOUT 30 COM PER SECOND RANGE). ON (B)(6) 2022, RENAL ARTERY OCCLUSIONS WERE NOTED, BUT NO INTERVENTION WAS PERFORMED. FINDINGS: COMPLETED WAS ABDOMINAL AND PELVIC ARTERIOGRAM, WHICH REVEALED CELIAC ARTERY STENT WAS WIDELY PATENT, THE RIGHT AND LEFT RENAL ARTERY STENTS WERE ANATOMICALLY ORIENTED CORRECTLY, WITH NO SIGNS OF RADIOGRAPHIC KINKING. HOWEVER, THE ANGIOGRAPHY SHOWED THE STENTS WERE COMPLETELY OCCLUDED FROM THE BRANCH POINT ALL THE WAY INTO THE DISTAL ASPECT OF THE ORIGIN OF THE VESSELS. BECAUSE OF THE PROLONGED ISCHEMIA TIME, REVASCULARIZA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16449059 ↗
• InjuryFeb 1, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2022, A STUDY PATIENT UNDERWENT AAA PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE UTILIZED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED IN OVERLAP FASHION, IN THE RIGHT RENAL ARTERY. DURING THE SIX-MONTH FOLLOW-UP ON (B)(6) 2023, X-RAY AND CT WERE PERFORMED. THE RESULTS SHOWED THE RIGHT RENAL ARTERY SIDE BRANCH COMPONENTS HAD BECOME OCCLUDED. AS REPORTED, BOTH DEVICES WERE OCCLUDED. THERE APPEARED TO BE COLLATERAL FLOW DISTAL OF THE DEVICES IMPLANTED IN THE RIGHT RENAL ARTERY. NO WIRE FRACTURE WAS OBSERVED. NO INTERVENTION WAS PERFORMED OR PLANNED. THE PHYSICIAN SUSPECTS REDUNDANCY/TORTUOSITY AND LONG LENGTH OF RENAL BRIDGING ENDOGRAFT CAUSED OR CONTRIBUTED TO THE OCCLUDED DEVICES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16278877 ↗
• InjuryDec 21, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE USED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED, ONE IN EACH RENAL ARTERY. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH RENAL FAILURE, RELATED TO A LEFT RENAL ARTERY STENT AND RIGHT ARTERY OCCLUSION. LEFT RENAL ARTERY OCCLUSION WAS REPORTED AS SPONTANEOUS; CAUSE UNKNOWN AND IS DEVICE-RELATED. ON OR AROUND ON (B)(6), PATIENT WAS TREATED WITH MEDICATIONS, LAB WORK AND SCANS WERE COMPLETED. NEPHROLOGY WAS CONSULTED FOR DIALYSIS. PATIENT RECEIVED HEMODIALYSIS STARTING ON (B)(6) 2022 AND CONTINUES TO RECEIVE TREATMENT THREE TIMES PER WEEK. ON (B)(6) 2022, THE RIGHT RENAL ARTERY WAS TREATED BY SUCTION THROMBECTOMY / TPA. COMPLETION ANGIOGRAM DEMONSTRATED WIDELY PATENT RIGHT RENAL ARTERY STENT WITH FLOW INTO THE RIGHT KIDNEY. RENAL ULTRASOUND DONE ON (B)(6) 2022, SHOWED RIGHT RENAL ARTERY: 0-59% STENOSIS WITH NO EVIDENCE OF HEMODYNAMICALLY SIGNIFICANT STENOSIS. ALSO NOTED: KNOWN ATROPHIC KIDNEY / LEFT RENAL ARTERY: UNABLE TO VISUALIZE; KNOWN OCCLUDED RENAL ARTERY. THE DEVICES REMAIN IMPLANTED. THE PATIENT TOLERATED THE

  Patient problems: Renal Impairment; Thrombosis/Thrombus

  MAUDE report 16026339 ↗
• InjuryOct 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE PATIENT'S LEFT RENAL ARTERY. ON (B)(6) 2022, LEFT RENAL ARTERY STENOSIS WAS OBSERVED. ON (B)(6) 2022, A LEFT RENAL STENT WAS PLACED. THE STENOSIS WAS REPORTEDLY RESOLVED. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Stenosis

  MAUDE report 15613030 ↗
• InjuryJul 19, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM MEDRIO CLINICAL STUDY (B)(4): ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES, IMPLANTED IN THE RIGHT RENAL ARTERY (22300501/BXA067902A), LEFT RENAL ARTERY (22300500/BXA067902A) AND SUPERIOR MESENTERIC ARTERY (22276962/BXA075902A). ON (B)(6) 2020, THROMBOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300501/BXA067902A) LOCATED IN THE RIGHT RENAL ARTERY. ON (B)(6) 2020, A BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE STENOSIS WITHIN THE RIGHT RENAL ARTERY STENT. ADDITIONALLY, A MEDTRONIC EVERFLEX STENT 7MM X 60MM WAS IMPLANTED TO TREAT THE OCCLUSION WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300501/BXA067902A). ON (B)(6) 2021, STENOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22276962/BXA075902A) LOCATED IN THE DISTAL SUPERIOR MESENTERIC ARTERY STENT. IT WAS ALSO NOTED THERE WAS STENOSIS WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300500/BXA067902A) LOCATED IN THE DISTAL LEFT RENAL ARTERY STENT. ON THE SAME DAY, AN AN

  Patient problems: Obstruction/Occlusion

  MAUDE report 15058628 ↗
• InjuryJul 19, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM MEDRIO CLINICAL STUDY AAA 17-01: ON AUGUST 13, 2020, THE PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES, IMPLANTED IN THE RIGHT RENAL ARTERY (22300501/BXA067902A), LEFT RENAL ARTERY (22300500/BXA067902A) AND SUPERIOR MESENTERIC ARTERY (22276962/BXA075902A). ON SEPTEMBER 15, 2020, THROMBOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300501/BXA067902A) LOCATED IN THE RIGHT RENAL ARTERY. ON SEPTEMBER 17, 2020, A BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE STENOSIS WITHIN THE RIGHT RENAL ARTERY STENT. ADDITIONALLY, A MEDTRONIC EVERFLEX STENT 7MM X 60MM WAS IMPLANTED TO TREAT THE OCCLUSION WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300501/BXA067902A). ON FEBRUARY 17, 2021, STENOSIS WAS OBSERVED WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22276962/BXA075902A) LOCATED IN THE DISTAL SUPERIOR MESENTERIC ARTERY STENT. IT WAS ALSO NOTED THERE WAS STENOSIS WITHIN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (22300500/BXA067902A) LOCATED IN THE DISTAL LEFT RENAL ARTERY ST

  Patient problems: Obstruction/Occlusion

  MAUDE report 15055239 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4). AE ONSET DATE: (B)(6) 2022. AE DESCRIPTION: HEMATOMA OF THE RIGHT RENAL ARTERY . AE OUTCOME: RECOVERED/RESOLVED - COIL EMBOLIZATION (SUPER SELECTIVE).

  Patient problems: Hematoma

  MAUDE report 14789746 ↗
• InjuryMay 23, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESES (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. ON (B)(6) 2021 OCCLUSION WAS OBSERVED IN THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS USED AS A BRIDGING STENT IN THE PATIENT'S RIGHT RENAL ARTERY. IT WAS REPORTED THAT THE OCCLUSION WAS SUSPECTED TO BE RELATED TO THE SHARP ANGLE THAT THE DEVICE TAKES AS IT BRIDGES FROM THE TAMBE DEVICE. REPORTEDLY THE PATIENT HAD A DECLINE IN RENAL FUNCTION BUT DOES NOT REQUIRE HEMODIALYSIS. IT WAS REPORTED THAT THE EVENT IS ONGOING. NO TREATMENT HAS BEEN PERFORMED OR IS PLANNED FOR THE FUTURE. THERE WERE NO FURTHER REPORTED ISSUES AND THERE WERE NO REPORTED ISSUES WITH ANY OTHER IMPLANTED DEVICES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14477887 ↗
• InjuryApr 12, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): SITE CONTACT INFORMATION OBTAINED FROM THE MEDRIO CLINICAL DATABASE AND ADDITIONAL PROCEDURE AND DEVICE DETAILS OBTAINED FROM THE MEDRIO SYSTEM ADMINISTRATOR. TREATING PHYSICIAN AND FACILITY: DR (B)(6); (B)(6). THE FOLLOWING PATIENT INFORMATION WAS OBTAINED FROM MEDRIO SYSTEM ADMINISTRATOR: PATIENT DEMOGRAPHIC INFO: MALE, DOB (B)(6), COMORBIDITIES-HYPERCHOLESTEROLEMIA, WEIGHT (B)(6). RECVD: 3/17/2022 TREATED ON (B)(6)2021. ADVERSE EVENT DATE IS NOT INPUTTED IN STUDY DATABASE BUT WAS REPORTED ON 3/17/2022. STUDY PT: (B)(6). A/E: OCCLUSION OF BILATERAL RENAL ARTERY STENTS. LOT/SERIAL NUMBERS IMPLANTED IN RENTAL ARTERIES: (B)(4).

  Patient problems: Obstruction/Occlusion

  MAUDE report 14085465 ↗
• InjuryAug 24, 2021Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT AORTIC ANEURYSM TREATMENT WITHIN THE TAMBE 1701 CLINICAL STUDY. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED IN THE LEFT RENAL ARTERY. ON (B)(6) 2021 THE LEFT RENAL ARTERY WAS STENOSED. AN ANGIOPLASTY WAS PERFORMED WITH A 6MM X 20MM BALLOON. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12359657 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 A PATIENT UNDERWENT TREATMENT OF A THORACO-ABDOMINAL ANEURYSM IN THE (B)(6) STUDY. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS USED IN THE RIGHT RENAL ARTERY. ON (B)(6) 2020 A REINTERVENTION TOOK PLACE WHEREBY THE RIGHT RENAL ARTERY BRANCH WAS DILATED BY BALLOON ANGIOPLASTY FOR OCCLUSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 10702305 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2022 · Sep 7, 2021 · Open, Classified
  Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diame