GORE VIABAHN VBX Balloon Expandable Endo BXB073902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00733132658640), received between May 23, 2024 and Sep 29, 2026 — classified as 2 deaths, 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 1, 2024Class IIOpen, Classified

   Due to packaging defects, sterility assurance and heparin activity may be compromised.

   Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937654 ↗
• InjuryAug 11, 2026Insufficient Device Problem Information

  Patient problems: Post Operative Wound Infection; Pseudoaneurysm

  MAUDE report 50215233 ↗
• InjuryApr 27, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED FROM A STUDY: ON (B)(6) 2026, A STUDY PATIENT UNDERWENT A THORACOABDOMINAL PROCEDURE AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICES WERE IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. CT ANGIOGRAPHY SHOWED HYPOPERFUSION OF THE RIGHT KIDNEY. THERE WAS CONCERN OF RENAL ARTERY OBSTRUCTION AND ISCHEMIA/INFARCT. CREATININE WAS 1.75. THE AAA REPAIR APPEARED STABLE. HEPARIN WAS ADMINISTERED. NEPHROLOGY EVALUATED WITH RECOMMENDATIONS FOR MONITORING URINE OUTPUT, HOLDING LISINOPRIL AND PROTONIX AND REPEAT OF URANALYSIS AND RENAL ULTRASOUND. ON (B)(6) 2026, ULTRASOUND SHOWED NORMAL KIDNEY SIZE BILATERALLY, AND OCCLUSION OF THE RIGHT RENAL ARTERY STENT, WHICH WAS KNOWN FROM THE CT SCAN. NORMAL FLOW VELOCITIES IN THE LEFT RENAL ARTERY WAS OBSERVED. URINALYSIS WAS WITHIN LIMITS. THE PATIENT ALSO REPORTED THE PAIN HAD LESSENED. NEPHROLOGY EVALUATED AGAIN AND HAD NO FURTHER RECOMMENDATIONS AS CREATININE WAS NOW STABLE (1.55 AT DISCHARGE) AND DOWN TRENDING, SUSPECTING THIS WILL BE THE

  Patient problems: Renal Impairment

  MAUDE report 25010384 ↗
• InjuryApr 16, 2026Complete Blockage

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). DURING THE INDEX PROCEDURE THE RIGHT RENAL ARTERY WAS COIL EMBOLIZED. ON (B)(6) 2026, RIGHT RENAL INFARCT WAS IDENTIFIED.

  Patient problems: Stenosis

  MAUDE report 24899364 ↗
• InjuryApr 15, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED BY CLINICAL COMPLAINT SPECIALIST: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. ACUTE KIDNEY INJURY WAS IDENTIFIED. ON (B)(6) 2026, OCCLUSION WAS IDENTIFIED IN BOTH RIGHT AND LEFT RENAL ARTERIES. RENAL ARTERY INFARCT WAS NOTED IN BOTH RIGHT AND LEFT RENAL ARTERIES AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2026, THE PATIENT PRESENTED WITH NAUSEA, VOMITING AND GENERAL WEAKNESS AND A THROMBECTOMY WAS PERFORMED IN THE RIGHT AND LEFT RENAL ARTERIES. ON (B)(6) 2026, A SPLENIC INFARCT WAS NOTED. THE CAUSE OF SPLENIC INFARCT WAS NOT RELATED TO ANY GORE DEVICE. NO TREATMENT WAS REQUIRED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24885372 ↗
• InjuryApr 2, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE VIA AAA 2401 TAMBE STUDY: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE TO TREAT A DEGENERATIVE ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). A VBX DEVICE WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY, TWO IN THE RIGHT RENAL ARTERY, ONE IN THE CELIAC TRUNK, AND ONE IN THE LEFT RENAL ARTERY. A BOSTON SCIENTIFIC INNOVA¿ VASCULAR SELF-EXPANDING STENT SYSTEM WAS PLACED IN THE RIGHT RENAL ARTERY AS WELL. THERE WAS KNOWN HEAVY SCARRING/CALCIFICATION OF THE RIGHT GROIN PRIOR TO PROCEDURE WHICH WAS NEAR OCCLUSIVE (RIGHT FEMORAL ARTERY OCCLUSION) AND THE SUTURE BROKE DURING THE ACCESS CLOSURE AFTER DEVICE DEPLOYMENTS IN THE RIGHT GROIN REQUIRING THROMBECTOMY, ENDARTERECTOMY AND BOVINE PATCH WITH LARGE AMOUNT OF THROMBUS REMOVED. PHYSICIAN STATED THIS ADVERSE EVENT WAS RELATED TO DISEASE CONDITION. ON (B)(6) 2026, THE FOLLOW UP CTA SCAN SHOWED THERE WAS A SMALL LEFT SPLENIC INFARCT AND SMALL RIGHT RENAL INFARCT WHICH WERE RELATED TO TH

  Patient problems: Embolism/Embolus

  MAUDE report 24771519 ↗
• InjuryApr 2, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE VIA AAA 2401 TAMBE STUDY: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE TO TREAT A DEGENERATIVE ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). A VBX DEVICE WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY, TWO IN THE RIGHT RENAL ARTERY, ONE IN THE CELIAC TRUNK, AND ONE IN THE LEFT RENAL ARTERY. A BOSTON SCIENTIFIC INNOVA¿ VASCULAR SELF-EXPANDING STENT SYSTEM WAS PLACED IN THE RIGHT RENAL ARTERY AS WELL. THERE WAS KNOWN HEAVY SCARRING/CALCIFICATION OF THE RIGHT GROIN PRIOR TO PROCEDURE WHICH WAS NEAR OCCLUSIVE (RIGHT FEMORAL ARTERY OCCLUSION) AND THE SUTURE BROKE DURING THE ACCESS CLOSURE AFTER DEVICE DEPLOYMENTS IN THE RIGHT GROIN REQUIRING THROMBECTOMY, ENDARTERECTOMY AND BOVINE PATCH WITH LARGE AMOUNT OF THROMBUS REMOVED. PHYSICIAN STATED THIS ADVERSE EVENT WAS RELATED TO DISEASE CONDITION. ON (B)(6) 2026, PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2026, A CTA SCAN WAS DONE AND SHOWED UNREMARKABLE KIDNEYS AND AN ENLARG

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 24770082 ↗
• 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

  MAUDE report 24682691 ↗
• MalfunctionJan 15, 2026Difficult or Delayed Positioning; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING A PROCEDURE, A 7X39 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DID NOT COMPLETELY EXPAND. IT WAS REPORTED THE PROCEDURE WAS A HYBRID CASE INVOLVING THE PATIENT'S LEFT SUBCLAVIAN ARTERY AND LEFT COMMON CAROTID ARTERY. THE CAROTID ARTERY WAS A CUT DOWN PROCEDURE FOR AN ENDARTERECTOMY. THE LEFT SUBCLAVIAN ARTERY TREATMENT WAS PERCUTANEOUS, WITH ACCESS FROM THE RIGHT GROIN. PRE-DILATION WAS NOT PERFORMED. A 7FR X 65CM TERUMO DESTINATION SHEATH WAS USED TO ADVANCE THE VBX DEVICE OVER A 260CM AMPLATZ WIRE. AS REPORTED, THE PHYSICIAN EXERTED EXTRA FORCE ON THE VBX DEVICE TO GET IT ACROSS THE HIGHLY CALCIFIED LESION THAT WAS ABOUT 90 PERCENT NARROWED. ONCE ACROSS THE LESION, THE VBX DEVICE WAS PULLED SLIGHTLY BACK FOR DEPLOYMENT. UPON INFLATION THE MOST PROXIMAL VBX STENT RING DID NOT EXPAND. THERE WERE NO ATTEMPTS TO USE ANOTHER BALLOON TO OPEN THE VBX STENT RING. THE VBX STENT WAS PUSHED INTO THE EXPOSED LEFT COMMON CAROTID ARTERY. THE PHYSICIAN THEN REMOVED THE PARTIALLY EXPANDED VBX STENT OUT MANUALLY. A NEW VBX DEVICE (8 X 39) WAS ADVANCED AND DEPLOYED WITHOUT ANY SEQUALAE TO THE PATIENT. IT WAS REPORTED THE PHYSICIAN S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087889 ↗
• InjuryNov 24, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, THE PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE WHERE TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE RIGHT RENAL ARTERY. ONE IMPLANTED IN THE MOST PROXIMAL (WITHIN THE PORTAL) (LSN (B)(6)) AND ONE THE SECOND MOST PROXIMAL (LSN (B)(6)). AN ANGIOGRAPHY WAS PERFORMED AND ALL DEVICES WERE PATENT AND NO ENDOLEAKS WERE PRESENT. PATIENT DID NOT COMPLETE THEIR ONE MONTH VISIT. ON (B)(6) 2025, THE PATIENT PRESENTED WITH THROMBOSIS IN THE VBX DEVICE(S) IN THE RIGHT RENAL ARTERY. AT THIS TIME, THE THROMBOSIS HAS NOT BEEN RESOLVED AND IS ONGOING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23639687 ↗
• InjurySep 17, 2025Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN UNKNOWN DISEASE/ETIOLOGY IN THE ILIAC ARTERY WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED. IT WAS REPORTED DURING THE PROCEDURE, A 7MM X 39MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS ADVANCED OVER A 0.035¿ GUIDEWIRE (BRAND UNKNOWN) THROUGH AN INTRODUCER SHEATH (BRAND UNKNOWN) TO THE TARGET TREATMENT SITE IN THE ILIAC ARTERY. THE VESSEL HAD BEN PRE-DILATED, AND NO RESISTANCE WAS NOTED DURING DEVICE ADVANCEMENT. NO PREVIOUSLY IMPLANTED DEVICES WERE ENCOUNTERED, ALTHOUGH CALCIFICATION WAS NOTED. DURING INITIAL DEPLOYMENT, THE BALLOON RUPTURED AND IT SEPARATED FROM THE VBX DELIVERY SYSTEM, BECOMING DISLODGED WITHIN THE PATIENT. AS A RESULT, POST-DILATATION WAS PERFORMED SINCE THE VBX DEVICE HAD NOT REACHED ITS NOMINAL PRESSURE. IT REMAINS UNKNOWN WHETHER POST-DILATATION OCCURRED BEFORE OR AFTER RETRIEVAL OF THE RUPTURED BALLOON. THE TIMING OF THE PHYSICIAN'S SNARE ATTEMPT TO RETRIEVE THE RUPTURED BALLOON IS ALSO UNKNOWN. AFTER THIS ATTEMPT FAILED, A CUTDOWN PROCEDURE WAS PERFORMED TO RETRIEVE THE RUPTURED BALLOON WITHIN THE PATIENT. THE VBX DEVICE HAD ALREADY BEEN DEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074001 ↗
• InjuryJun 16, 2025Partial Blockage; Partial Blockage

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) TO TREAT AND AORTIC ANEURYSM. IT WAS REPORTED BY A NON-IMPLANTING PHYSICIAN THAT THERE WAS A LEFT RENAL ARTERY STENT OCCLUSION POST TAMBE PROCEDURE. THE LEFT RENAL WAS MEASURING 4.99-4.58MM AT THE TIME OF THE PROCEDURE. IT WAS REPORTED THAT NO REINTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214535 ↗
• InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A CALCIFIED SUPERIOR MESENTERIC ARTERY (SMA) USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHILE ATTEMPTING TO ADVANCE THE VBX DEVICE OVER AN AMPLATZ GUIDEWIRE (SIZE UNKNOWN) AND THROUGH A 7FR TERUMO SHEATH TO REACH THE TARGET TREATMENT SITE. DUE TO SEVERE STENOSIS OF THE SMA, THE TARGET AREA COULD NOT BE REACHED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE VBX DEVICE THROUGH THE SHEATH AND IT WAS OBSERVED THAT THE BACK END OF THE DEVICE GOT CAUGHT ON THE SHEATH AND THE STENT DISLODGED FROM THE BALLOON IN THE AORTA, RESULTING IN THE PROCEDURE BEING ABORTED. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A GROIN CUTDOWN TO RETRIEVE THE DISLODGED STENT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH A REPLACEMENT VBX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947085 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RENAL ARTERY. IT WAS REPORTED THAT THE RIGHT RENAL ARTERY WAS CANNULATED AND STENTED WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE LEFT RENAL ARTERY WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A 6MM X 59MM AND 9MM X 39MM VBX DEVICES AND LAST THE CELIAC ARTERY WITH A 6MM X 59MM VBX DEVICE. THE PROCEDURE FOR THE TAMBE TOOK APPROXIMATELY THREE HOURS. UPON THE FINAL COMPLETION ANGIOGRAM, IT WAS NOTED THAT THE RENAL ARTERIES DID NOT HAVE FLOW. THE PHYSICIAN CANNULATED THE RENAL ARTERIES AND DISCOVERED BOTH RENAL ARTERIES HAD THROMBUS PRESENT. THE PHYSICIAN PREFORMED A THROMBECTOMY WITH PENUMBRA WHERE SHE REESTABLISHED FLOW. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO VISUALIZE THE RENAL ARTERIES TO MAKE SURE THE STENTS WERE NOT CRUSHED. EVERYTHING LOOKED APPROPRIATE VIA IVUS. DURING THIS TIME, THE PHYSICIAN DISCOVERED THAT ANESTHESIA HAD BEEN STRUGGLING KEEPING THE ACTIVATED CLOTTING TIME (ACT) THERAP

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21727237 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RENAL ARTERY. IT WAS REPORTED THAT THE RIGHT RENAL ARTERY WAS CANNULATED AND STENTED WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE LEFT RENAL ARTERY WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A 6MM X 59MM AND 9MM X 39MM VBX DEVICES AND LAST THE CELIAC ARTERY WITH A 6MM X 59MM VBX DEVICE. THE PROCEDURE FOR THE TAMBE TOOK APPROXIMATELY THREE HOURS. UPON THE FINAL COMPLETION ANGIOGRAM, IT WAS NOTED THAT THE RENAL ARTERIES DID NOT HAVE FLOW. THE PHYSICIAN CANNULATED THE RENAL ARTERIES AND DISCOVERED BOTH RENAL ARTERIES HAD THROMBUS PRESENT. THE PHYSICIAN PREFORMED A THROMBECTOMY WITH PENUMBRA WHERE SHE REESTABLISHED FLOW. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO VISUALIZE THE RENAL ARTERIES TO MAKE SURE THE STENTS WERE NOT CRUSHED. EVERYTHING LOOKED APPROPRIATE VIA IVUS. DURING THIS TIME, THE PHYSICIAN DISCOVERED THAT ANESTHESIA HAD BEEN STRUGGLING KEEPING THE ACTIVATED CLOTTING TIME (ACT) THERAP

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21727227 ↗
• InjuryMar 15, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS) WAS IMPLANTED TO TREAT AN ANEURYSM. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED IN THE RIGHT RENAL ARTERY. ON (B)(6) 2025 POST-PROCEDURE, CT IMAGING SHOWED THROMBOSED VBX STENTS IN THE RIGHT RENAL ARTERY (RRA). DISTAL DISSECTION WAS ALSO NOTED. IMPLANTED MOST DISTALLY IN THE RRA WAS THE 6 X79 VBX STENT. AN INTERVENTION WAS PERFORMED. AFTER THE THROMBECTOMY, A BARE METAL STENT WAS IMPLANTED FOR A 2CM DISTAL EXTENSION. FOR RADIAL STRENGTH, THE EXISTING VBX STENTS WERE RELINED WITH IMPLANTATION OF A NEW 7X79 VBX DEVICE. AS REPORTED, THE CAUSE OF THROMBOSIS IS UNKNOWN; HOWEVER, PHYSICIAN STATED THE OCCLUSION COULD BE RELATED TO THE RRA DISSECTION. THERE WERE NO ISSUES NOTED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21613118 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, A PATIENT PRESENT FOR TREATMENT OF A STENOTIC OCCLUSION IN THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN ACCESSED FROM THE LEFT GROIN AND ENDARTERECTOMY WAS PERFORMED. AS REPORTED, THE PATIENT'S ILIAC ARTERY WAS TORTUOUS AND CALCIFIED. AS THE PHYSICIAN ADVANCED THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) PROXIMALLY INTO THE LEFT COMMON FEMORAL ARTERY TOWARDS THE EXTERNAL ILIAC ARTERY, THE VBX STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN STATED THAT BECAUSE THE VBX STENT DISLODGED JUST PROXIMAL TO THE ENDARTERECTOMY SITE, HE WAS ABLE TO REMOVE THE STENT EASILY. A NEW 7 X 39 VBX DEVICE WAS ADVANCED TO THE LESION WITH NO ISSUES. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726751 ↗
• MalfunctionJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A COMMON ILIAC ARTERY STENOSIS, A 6FR CORDIS BRITE TIP SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT) OVER AN AMPLATZ WIRE. AS REPORTED, THE PATIENT'S ANATOMY WAS ALSO HEAVILY CALCIFIED. THE VBX STENT CROSSED THE LESION, AND IT WAS BEING PULLED BACK CLOSE TO THE SHEATH WHEN THE STENT DISLODGED. THE PHYSICIAN TRIED TO SNARE THE CONSTRAINED STENT, BUT THIS WAS NOT SUCCESSFUL. A NEW VBX STENT WAS DEPLOYED TO PIN THE CONSTRAINED VBX STENT AGAINST THE PATIENT'S VESSEL WALL. A NEW VBX STENT WAS IMPLANTED WITH GOOD RESULTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE PHYSICIAN STATED THE CONDITION OF THE PATIENT'S ANATOMY MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19648177 ↗
• MalfunctionMay 23, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A AAA FENESTRATED CASE WAS PERFORMED. DURING THIS PROCEDURE, BILATERAL ACCESS WAS FROM THE FEMORAL ARTERIES AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE USED FOR IMPLANT OF COOK AORTIC DEVICES AND GORE AORTIC DEVICES. THE PATIENT¿S ANATOMY WAS DESCRIBED AS ¿VERY TIGHT¿ AND TORTUROUS. DURING THIS PROCEDURE, A LARGE ANEURYSMAL LEFT HYPOGASTRIC ARTERY ALSO REQUIRED TREATMENT WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT). THE 6 X 29 VBX DEVICE WAS ADVANCED OVER AN .035 STIFF GLIDEWIRE. DUE TO THE SHARP ANGLE INTO THE HYPOGASTRIC ARTERY, THE VBX DEVICE WAS UNABLE TO TRACK INTO THE OSTIUM OF THE ARTERY. AS THE VBX DEVICE WAS BEING WITHDRAWN, IT BECAME STUCK ON A STENT OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AT THE GATE OF THE MAIN BODY GRAFT. WHILE PULLED THE VBX DELIVERY CATHETER, THE VBX STENT STENT WAS DISLODGED FROM THE CATHETER. A GORE® EXCLUDER® AAA ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT) WAS DEPLOYED IN THE GATE OF THE IBE TO TRAP THE DISLODGED VBX STENT. THE DISLODGED STENT REMAINS IN THE PATIENT. A NEW VBX DEVICE (7X39) WAS ABLE TO BE ADVANCED INTO THE HYPOGASTRIC ARTERY ANE

  Patient problems: Foreign Body In Patient

  MAUDE report 19388328 ↗

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