GORE VIABAHN VBX Balloon Expandable Endo BXA095902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132637379), received between Dec 5, 2020 and May 13, 2026 — classified as 1 death, 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathMay 13, 2026Complete Blockage

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2021, A STUDY PATIENT UNDERWENT A GORE® EXCLUDER® 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. A VBX DEVICE WAS IMPLANTED IN THE CELIAC ARTERY. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A CELIAC STENT THROMBOSIS, AND DIAGNOSIS OF EPIGASTRIC PAIN. ON THE SAME DAY, IV HEPARIN AND IV ANTIBIOTICS WERE ADMINISTERED ALONG WITH ELIQUIS AND PO ANTIBIOTICS. LAPAROSCOPIC CHOLECYSTECTOMY WITH DRAIN WAS DONE. ON (B)(6) 2025, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH A COMMON BILE DUCT STENT WAS PERFORMED. DISCHARGE DIAGNOSIS WAS GANGRENOUS CHOLECYSTITIS. ON (B)(6) 2025, PATIENT WAS ADMITTED WITH ABDOMINAL PAIN. HEPATIC DRAIN WAS PERFORMED. ON (B)(6) 2026, THE PATIENT HAD GASTRIC ISCHEMIA THAT LED TO DEATH ON (B)(6) 2026. AS REPORTED, THE CAUSE OF THE EPIGASTRIC ISCHEMIA WAS AN OCCLUDED CELIAC ARTERY. IT WAS REPORTED INTERVENTION WAS NOT ATTEMPTED.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 25163020 ↗
• InjuryFeb 23, 2026Complete Blockage; Insufficient Device Problem Information

  ON (b)(6), 2021, THE PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE WHERE MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED IN THE VISCERAL VESSELS AS BRANCH COMPONENTS OF THE TAMBE DEVICE. INDEX PROCEDURE WAS SUCCESSFUL AND ALL DEVICES WERE PATENT POST INDEX PROCEDURE. ON (b)(6), 2025, THE PATIENT PRESENTED WITH AN OCCLUDED VBX ENDOPROSTHESIS IN THE CELIAC ARTERY. THIS EVENT IS ONGOING AND REQUIRES TREATMENT. WITH THE WHOLE VBX ENDOPROSTHESIS BEING OCCLUDED, THE PATIENT IS FAILING TO THRIVE. IT WAS REPORTED THE PHYSICIAN BELIEVES THE OCCLUSION WAS DUE TO A KINK AND EXTERNAL COMPRESSION OF CELIAC ARTERY.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 24416495 ↗
• InjuryFeb 13, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AND PARARENAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. ON (B)(6) 2024, AN INDETERMINATE ENDOLEAK WAS OBSERVED IN THE SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION OF THE ENDOLEAK WHEREBY BALLOON ANGIOPLASTY WAS PERFORMED USING A PERIPHERAL STENT GRAFT.

  Patient problems: Clinical Endoleak

  MAUDE report 21381612 ↗
• MalfunctionJan 13, 2025Fracture; Fracture

  A STUDY ALERT FROM THE (B)(4) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2019, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PIVOTAL STUDY. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VBX DEVICE) DEVICES WERE USED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. ONE GORE® VBX DEVICE WAS IMPLANTED IN THE CELIAC ARTERY. AT 60-MONTH FOLLOW-UP ON (B)(6) 2024, CTA IMAGES INDICATED CELIAC ARTERY WIRE FRACTURE OF THE GORE® VBX DEVICE. THE STENT FRACTURE WAS SEEN IN THE 4TH STENT ROW FROM THE DISTAL END OF THE COMPONENT. TWO LOCATIONS WITHIN THAT ROW HAD FRACTURES. THE WIRE FRACTURE WAS NOT IN THE SEALING ROW OF THE DEVICE. THERE IS NO PRESENCE OF DEVICE MIGRATION, NO COMPRESSION / INVAGINATION OBSERVED. AND THE GORE® VBX DEVICE IS NOT KINKED. CTA IMAGES TAKEN ON THIS DATE SHOWED ALL BRANCH DEVICES REMAIN PATENT. NO INTERVENTION WAS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137968 ↗
• MalfunctionJan 13, 2025Material Integrity Problem; Material Integrity Problem

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2022, A MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. 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 SEPTEMBER 30, 2022, DURING AN UNSCHEDULED FOLLOW-UP VISIT, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING WAS PERFORMED. DEVICE OVALIZATION OF THE VBX DEVICE CELIAC ARTERY SIDE BRANCH COMPONENT WITHIN THE CELIAC ARTERY SIDE BRANCH COMPONENT WAS OBSERVED. ALL BRANCH DEVICES WERE NOTED AS PATENT AND THERE WERE NO VBX DEVICE WIRE FRACTURES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137872 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  THE FOLLOWING INFORMATION WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT AN AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. DURING THE STUDY PATIENT'S FOLLOW-UP VISIT ON (B)(6) 2024, IMAGING SHOWED STENT FRACTURES APPEAR TO BE IN THE 5TH, 6TH, AND 7TH STENT ROWS COUNTING BACK FROM THE DISTAL END OF THE COMPONENT WITHIN THE CELIAC ARTERY. FRACTURE WAS NOT IN THE SEALING ROW OF DEVICE. DUS IMAGING SHOWED ALL BRANCH DEVICES REMAIN PATENT. ACTION TAKEN WAS PHYSICIAN WILL CONTINUE TO MONITOR STUDY PATIENT FOR SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725803 ↗
• MalfunctionNov 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2020, A STUDY PATIENT UNDERWENT A AAA PROCEDURE AND A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCHED DEVICES IN THE VISCERAL ARTERIES. AT 36 MONTHS FOLLOW-UP ON (B)(6) 2023, IMAGING SHOWED OVALIZATION OF THE CELIAC ARTERY DEVICE AT THE ORIGIN. IMAGING SHOWED ALL BRANCH DEVICES REMAIN PATENT, EXCEPT FOR THE RIGHT RENAL ARTERY THAT HAD A BARE METAL STENT (NON-GORE DEVICE) THAT REMAINS OCCLUDED. THERE WAS NO STENT FRACTURES OBSERVED. THE STUDY PATIENT IS ASYMPTOMATIC AND NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20714622 ↗
• MalfunctionNov 1, 2024Fracture; Fracture

  THE FOLLOWING INFORMATION WAS RECEIVED FROM A CLINICAL STUDY: ON (B)(6) 2021, A STUDY PATIENT UNDERWENT A AAA PROCEDURE WHERE A TAMBE DEVICE WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. AT 36 MONTH FOLLOW-UP, IMAGING DONE ON (B)(6) 2024, SHOWED A WIRE FRACTURE OF THE CELIAC ARTERY SIDE BRANCH COMPONENT. AS REPORTED IN THE OBSERVATION REPORT, THERE APPEARED TO BE TWO LOCATIONS OF FRACTURE WITHIN THE 2 MOST DISTAL STENT ROWS. THE SCAN BEGAN DISTAL TO THE LEFT SUBCLAVIAN ARTERY. AS REPORTED, ALL BRANCH DEVICES WERE PATENT, INCLUDING THE VBX DEVICE EXISTING IN THE CELIAC ARTERY. THE X-RAY DONE ON THE SAME DAY REPORTS THE STENT FRACTURE WAS VISUALIZED IN THE LPO VIEW. NO INTERVENTION WAS REPORTED. ACTION TAKEN BY PHYSICIAN WAS TO CONTINUE CLOSE MONITORING. THE PATIENT APPEARS TO BE ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592395 ↗
• 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 (B)(6) 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 TO COVER THE TWO VBX DEVICES IMPLANTED IN THE CELIAC ARTERY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19800534 ↗
• MalfunctionApr 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION FROM A CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. IMPLANTED WERE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE), TWO DEVICES IN SUPERIOR MESENTERIC ARTERY (SMA) IN OVERLAPPED FASHION, AND ONE EACH IN THE LEFT AND RIGHT RENAL ARTERIES. ONE VBX DEVICE WAS ALSO IMPLANTED IN THE MOST PROXIMAL WITHIN THE PORTAL OF THE CELIAC ARTERY. ON (B)(6) 2023, A DISSECTION OF THE DISTAL CELIAC ARTERY WAS OBSERVED. NO INTERVENTION WAS REPORTED. ON (B)(6) 2023, THE CORE LAB IMAGING (CTA) SHOWED A DISSECTION WAS PRESENT IN THE CELIAC ARTERY WHICH EXTENDED INTO THE HEPATIC AND SPLENIC ARTERY. AS REPORTED, THE DISSECTION WAS FOUND ON THE PREVIOUS VISIT. ALSO OBSERVED WAS A DEVICE OVALIZATION (COMPRESSION) OF THE CELIAC ARTERY SIDE BRANCH COMPONENT AS IT ENTERS THE CELIAC ARTERY. AS REPORTED, THE CELIAC ARTERY COMPONENT REMAINED PATENT. ON (B)(6) 2023, THE CORE LAB IMAGING (CTA) DISSECTION WAS STILL PRESENT IN THE CELIAC ARTERY WHICH EXTENDS INTO THE HEPATIC AND SPLENIC ARTERY. THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071671 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  ON (B)(6) 2021, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN THE AAA1701 TAMBE PIVOTAL STUDY. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS BRANCH DEVICES. A VBX DEVICE WAS IMPLANTED IN EACH OF THE VISCERAL VESSELS (LEFT RENAL, RIGHT RENAL, CELIAC, AND SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2023, CTA IMAGING (B)(6) REVEALED A WIRE FRACTURE OF THE CELIAC ARTERY SIDE BRANCH COMPONENT ON THE DISTAL END WITHIN THE CELIAC ARTERY. MULTIPLE ROWS APPEARED TO BE IMPACTED. ALL VISCERAL VESSELS WERE PATENT, INCLUDING THE CELIAC ARTERY AT THE TIME OF SCAN. NO ACTION WAS NEEDED FOR THE OBSERVED FRACTURE. PATIENT APPEARED TO BE ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984059 ↗
• MalfunctionMar 18, 2024Fracture; Fracture

  THE FOLLOWING INFORMATION WAS FROM A STUDY: ON MAY 2021, A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED AS A SIDE BRANCH WITHIN THE CELIAC ARTERY, MOST PROXIMAL WITHIN THE PORTAL. DURING AN INTERIM PATIENT VISIT ON (B)(6) 2022, A WIRE FRACTURE WAS OBSERVED ON THE CELIAC ARTERY SIDE BRANCH COMPONENT USING A CT IMAGING ONLY. THE FRACTURES APPEAR TO BE IN THE 3RD AND 4TH STENT ROWS FROM THE DISTAL END OF THE SIDE BRANCH COMPONENT WITHIN THE CELIAC ARTERY. IT WAS NOTED A VERY HIGH QUALITY CT SCAN WITH 0.60 SLICE THICKNESS AND 0.40 SPACING WAS USED TO MAKE THIS DEFINITIVE OBSERVATION. IT IS WAS NOT SPECIFIED IT PATIENT EXPERIENCED ANY ADVERSE CONSEQUENCES FROM THE OBSERVED FRACTURE. IT IS UNKNOWN IF THE FRACTURE REQUIRED AN INTERVENTION. ON (B)(6) 2023, THE PATIENT EXPIRED DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. AS REPORTED, THE PATIENT'S DEATH WAS UNRELATED TO THE GORE DEVICES IMPLANTED DURING THE AAA PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927072 ↗
• InjuryFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT IN THE SUBCLAVIAN VEIN FOR A STENOTIC LESION USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE RIGHT UPPER ARM ARTERIOVENOUS (AV) GRAFT WAS USED AS THE ACCESS SITE. IT WAS REPORTED THE PHYSICIAN WAS DOING AN AV ACCESS SITE THROMBECTOMY IN THE RIGHT ARM. UPON COMPLETION OF THE THROMBECTOMY, STENOSIS IN THE SUBCLAVIAN VEIN WAS IDENTIFIED, AS WELL AS A RESIDUAL CLOT IN THE PREVIOUSLY PLACED STENT IN THE OUTFLOW VEIN. USING AN 8F BRITE TIP INTERVENTIONAL SHEATH (5.5 CM) AND .035 COOK BENTSON WIRE GUIDE (180 CM) AN ATTEMPT WAS MADE TO PLACE THE 9 X 59 VBX DEVICE IN THE SUBCLAVIAN VEIN. REPORTEDLY, THE DEVICE ADVANCED INTO THE PATIENT AND PAST THE TIP OF THE SHEATH. AT THIS TIME IT WAS NOTICED THERE WAS NO WIRE COMING OUT THE BACK OF THE 135 VBX DEVICE CATHETER. IN AN ATTEMPT TO FEED THE WIRE BACK OUT OF THE PATIENT, THE VBX DELIVERY SYSTEM CATHETER WAS WITHDRAWN THROUGH THE SHEATH AND RESISTANCE WAS MET. THE VBX STENT-GRAFT CAME OFF THE BALLOON, AS THE BALLOON CAME OUT OF THE SHEATH. THE VBX STENT-GRAFT REMAINED ON THE BENTSON WIRE GUIDE AT THE TIP OF THE SHEATH. A CUT DOWN OF THE RIGHT ARM AV G

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16299965 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX), GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, GORE® MOLDING & OCCLUSION BALLOON CATHETERS, GORE® TRI-LOBE BALLOON CATHETERS, GORE® DRYSEAL FLEX INTRODUCER SHEATHS, AND GORE® TRI LUMEN CATHETERS IN THE AAA1701 TAMBE PIVOTAL STUDY. ON THE MORNING OF (B)(6) 2021 THE PATIENT REPORTED BLURRED VISION (DIPLOPIA). THE PATIENT WAS EVALUATED BY THE HOSPITAL STROKE TEAM AND AN MRI OF THE PATIENT'S BRAIN WAS PERFORMED. IT WAS REPORTED THAT THE MRI WAS WITHOUT EVIDENCE OF AN ACUTE STROKE. IT WAS REPORTED THAT THE PATIENT'S BLURRED VISION RESOLVED ITSELF LATER ON THE MORNING OF (B)(6) 2021. THERE WAS REPORTEDLY NO RESIDUAL.

  Patient problems: Transient Ischemic Attack

  MAUDE report 14796009 ↗
• InjuryJun 20, 2022Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS OBTAINED FROM MEDRIO: QUERY DETAILS NAME: (B)(6), SUBJECT: (B)(4), SITE: (B)(6), FORM: FORM 22 - ADVERSE EVENT, VISIT: ADVERSE EVENT - 04, VARIABLE: AETERM @ SAME FORM, DESCRIPTION: ADVERSE EVENT, CREATED BY: SYSTEM.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14750967 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT UNDERWENT THORACO-ABDOMINAL ANEURYSM TREATMENT AS A SUBJECT IN THE (B)(6) CLINICAL TRIAL. GORE¿ VIABAHN¿ VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN THE SMA. ON (B)(6) 2019 A TYPE IC ENDOLEAK WAS DISCOVERED IN THE SMA. ON (B)(6) 2021 THE TYPE IC ENDOLEAK WAS TREATED BY MEANS OF BALLOON ANGIOPLASTY AND PLACEMENT OF A PERIPHERAL STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12362537 ↗
• MalfunctionDec 5, 2020Inflation Problem; Inflation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT PRESENTED FOR A SNORKEL CASE. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED INTO THE CELIAC ARTERY. DURING THE INFLATION OF THE DEVICE, ONLY 4 ATMOSPHERES COULD BE OBTAINED. THE VBX BALLOON WAS REMOVED AND REPLACED WITH A DIFFERENT BALLOON, SUCCESSFULLY DEPLOYING THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10952766 ↗

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