GORE TAG Conformable Thoracic Endoprosthesis TGU454520Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132617753), received between Jun 30, 2018 and Jun 18, 2025 — classified as 3 deaths, 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (P040043); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WITH A MAXIMUM DIAMETER THAT MEASURED 78.0MM; AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS (TGU454520/(B)(6), TGU454515/(B)(6). THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED THIS DATE DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 77MM. ON (B)(6) 2018, THE PATIENT WAS REPORTED TO HAVE A TYPE I OR II ENDOLEAK, CTA PERFORMED THIS DATE DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 78.0MM ON (B)(6) 2018, THE PATIENT WAS REPORTED TO HAVE UNDERGONE A CONVERSION TO OPEN REPAIR TO TREAT AN INDETERMINATE ENDOLEAK AND ANEURYSMAL DEGENERATION BETWEEN THE THORACIC AND AORTIC STENT GRAFTS. ON (B)(6) 2020, THE CSD REPORTS THE PATIENT DIED, A CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Clinical Endoleak

  MAUDE report 22285719 ↗
• InjuryMar 31, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2017, CORE LAB PRE-TREATMENT IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 46MM. FROM ON (B)(6) 2018 TO ON (B)(6) 2022, THE ANEURYSM ENLARGED FROM 37MM TO 47.6MM/45MM BASED ON THE CORE LAB FINDINGS. ON (B)(6) 2023, A DISTAL TYPE I ENDOLEAK WAS DETERMINED BY THE SITE. NO TREATMENT WAS REPORTED. THE ENDOLEAK IS ONGOING. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16660574 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, A PATIENT UNDERWENT TREATMENT OF A THORACIC ANEURYSM, ZONE 2, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE) AND EXTENSION BELOW THIS WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2017, THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AREA WAS 43MM. ON (B)(6) 2017, THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AREA WAS 31MM. ON (B)(6) 2018, THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AREA WAS 54MM. ON (B)(6) 2022, THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED AREA WAS 53MM AND A RIGHT FEMORAL ANEURYSM WAS IDENTIFIED.

  Patient problems: Aneurysm expansion

  MAUDE report 15528843 ↗
• InjurySep 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2019, PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 0, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE MAXIMUM ANEURYSM DIAMETER MEASURED 63.2MM. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2019, FOLLOW UP COMPUTED TOMOGRAPHY (CT) IMAGES, REVEALED A TYPE II ENDOLEAK. NO ANEURYSM ENLARGEMENT WAS NOTED AT THIS TIME AND NO REINTERVENTION WAS REQUIRED. IT WAS REPORTED THAT FOLLOW UP COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2022, REVEALED A DISTAL TYPE 1B ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 67MM. A REINTERVENTION IS SCHEDULED IN ORDER TO TREAT THE PATIENT BUT NO DATE FOR THE PROCEDURE HAS BEEN SET. THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 15348847 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATHOLOGY OF THE TREATMENT IS NOT KNOWN. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A THORACIC AORTIC DISSECTION. THE LOCATION OF THE DISSECTION AND THE CAUSE OF THE DISSECTION WAS NOT REPORTED TO GORE. ON THE SAME DAY, TWO ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED TO TREAT THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 11229276 ↗
• InjuryNov 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. ON (B)(6) 2020, COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ACCORDING TO THE REPORT, THE ANEURYSM HAD ENLARGED TO A MEASUREMENT OF 9CM IN DIAMETER (ORIGINAL MEASUREMENT IS UNKNOWN). ON (B)(6) 2020, A RE-INTERVENTION PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL GORE® TAG® DEVICE WAS IMPLANTED TO EXTEND THE STENT GRAFT SYSTEM PROXIMALLY AND TREAT THE TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10885751 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL ANEURYSM AND WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES IN THE DESCENDING THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH COOK ZENITH FENESTRATED ENDOVASCULAR (ZFEN) DEVICE AND ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFTS WITHIN THE ABDOMINAL AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THIS PATIENT UNDERWENT EMERGENT TREATMENT FOR A RUPTURED THORACOABDOMINAL ANEURYSM DISTAL TO THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES IN THE AREA OF THE GAP FROM THE ABDOMINAL DEVICES. AN UNKNOWN ENDOLEAK IN THE DISTAL AORTA WAS SUSPECTED BUT WAS UNABLE TO BE CONFIRMED. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WAS ADVANCED VIA A GORE® DRYSEAL FLEX INTRODUCER SHEATH HOWEVER THE SHEATH WAS UNABLE TO BE ADVANCED TO THE INTENDED LOCATION DUE TO THE SMALL DIAMETER OF THE PATIENT¿S FEMORAL ARTERIES. THE SHEATH AND UNDEPLOYED DEVICE WERE WITHDRAWN AND TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS WERE IMPLANTED INSTEAD TO TREAT THE RUPTURE. THE PATIEN

  Patient problems: Aneurysm; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10029765 ↗
• InjuryMar 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2020 CT SCAN IDENTIFICATION OF A DISTAL TYPE I ENDOLEAK WAS REPORTED. NO ANEURYSM ENLARGEMENT WAS REPORTED. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS PLACED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE PROCEDURE WAS REPORTEDLY SUCCESSFUL. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788001 ↗
• InjuryOct 8, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS NOTED THAT, DUE TO THE C-ARM ANGLE AT THE TIME OF DEVICE IMPLANT, VISUALIZATION FOR PLACEMENT USING THE C-ARM ANGLE WAS NOT OPTIMAL. REPORTEDLY THE DEVICES WERE PLACED SLIGHTLY SHORT OF THE INTENDED LANDING ZONE BOTH PROXIMALLY AND DISTALLY. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED. REPORTEDLY A PROXIMAL TYPE I ENDOLEAK WAS NOTED ON THE PROXIMAL TGU454520 CONFORMABLE GORE® TAG® THORACIC DEVICE, AND A DISTAL TYPE I ENDOLEAK WAS NOTED ON THE DISTAL TGU454520 CONFORMABLE GORE® TAG® THORACIC DEVICE. NO ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2019 A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAKS. IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED CONFORMABLE GORE® TAG® THORACIC DEVICES WERE EXTENDED PROXIMALLY AND DISTALLY USING TWO TGM454510 GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9169950 ↗
• InjuryOct 8, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS NOTED THAT, DUE TO THE C-ARM ANGLE AT THE TIME OF DEVICE IMPLANT, VISUALIZATION FOR PLACEMENT USING THE C-ARM ANGLE WAS NOT OPTIMAL. REPORTEDLY THE DEVICES WERE PLACED SLIGHTLY SHORT OF THE INTENDED LANDING ZONE BOTH PROXIMALLY AND DISTALLY. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED. REPORTEDLY A PROXIMAL TYPE I ENDOLEAK WAS NOTED ON THE PROXIMAL TGU454520 CONFORMABLE GORE® TAG® THORACIC DEVICE, AND A DISTAL TYPE I ENDOLEAK WAS NOTED ON THE DISTAL TGU454520 CONFORMABLE GORE® TAG® THORACIC DEVICE. NO ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2019 A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAKS. IT WAS REPORTED THAT THE PREVIOUSLY IMPLANTED CONFORMABLE GORE® TAG® THORACIC DEVICES WERE EXTENDED PROXIMALLY AND DISTALLY USING TWO TGM454510 GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9169945 ↗
• InjuryJul 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2016 A PATIENT WAS UNDERGOING TREATMENT OF A DESCENDING THORACIC ANEURYSM, ZONE 4, MASURING 60.6MM WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. A PROXIMAL TYPE I ENDOLEAK WAS REPORTED. ON (B)(6), 2016 THE ANEURYSM MEASURED 47MM BY CT. ON (B)(6), 2017 THE ANEUSRYSM MEASURED 59MM BY CT. ON (B)(6), 2017 THE ANEURYSM MEASURED 64MM BY CT. ON (B)(6), 2017 THE ANEURYSM MEASURED 60MM BY CT. ON (B)(6), 2018 A REINTERVENTION, WHEREBY A TOTAL AORTIC ARCH REPAIR WITH DEBRANCHING TO LEFT COMMON CAROTID AND RIGHT COMMON CAROTID, TOOK PLACE. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 8809933 ↗
• InjuryJul 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2017, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, A PROCEDURE TO TREAT THE PROXIMAL TYPE I ENDOLEAK WAS PERFORMED (THIS WAS REPORTED ON MFR REPORT 2017233-2019-00369). DETAILS OF THE TREATMENT WAS NOT REPORTED TO GORE. DURING THE PROCEDURE, A DISTAL TYPE I ENDOLEAK WAS ALSO DISCOVERED. ON (B)(6) 2018, AN INTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK, WHEREBY ENDOANCHORS WERE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781166 ↗
• DeathJun 14, 2019Collapse; Patient-Device Incompatibility; Collapse; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT HAD A THORACIC ENDOVASCULAR REPAIR USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT HAD VERY TORTUROUS ANATOMY AND THE SECOND DEVICE DEPLOYED WAS COMPRESSED IMMEDIATELY AFTER DEPLOYMENT. THEY PHYSICIAN BALLOONED THE DEVICE AND WHILE THE DEVICE WAS SLIGHTLY COMPRESSED DUE TO THE PATIENT'S ANATOMY, BLOOD FLOW WAS NORMAL. ON (B)(6) 2019 THE PATIENT PRESENTED WITH RENAL FAILURE AND AN AORTOBIFEMORAL BYPASS WAS PERFORMED. IT WAS REPORTED THAT DEVICE PREVIOUSLY COMPRESSED AND BALLOONED HAD COLLAPSED CAUSING THE RENAL FAILURE. IT WAS REPORTED THAT THE THORACIC AORTA WAS S SHAPED AND THE LUMEN SIZE WAS VARIABLE BASED ON HOW THE TORTUOSITY WAS KINKING THE AORTA. ON (B)(6) 2019 THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 8700695 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT UNDERWENT TREATMENT OF A RESIDUAL THORACIC AORTIC DISSECTION, ZONE 2, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED ALL DEVICES WERE IMPLANTED IN THE DESIRED LOCATIONS AND ALL COMPONENTS WERE PATENT, AS DEMONSTRATED BY ANGIOGRAPHY AT THE END OF THE PROCEDURE. ON (B)(6) 2019 THE PATIENT UNDERWENT A REINTERVENTION WHEREBY THE TREATMENT ZONE WAS EXTENDED DISTALLY FOR CHRONIC TYPE B DISSECTION AND ANEURYSMAL DEGENERATION. ON (B)(6) 2019 THE PATIENT WAS DISCHARGED AND THE DISSECTION WAS CONSIDERED RESOLVED.

  Patient problems: Vascular Dissection

  MAUDE report 8533765 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2014 A PATIENT WAS UNDERGOING TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM MEASURING 78.0MM WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2015 THE ANEURYSM MEASURED 60.5MM. ON (B)(6) 2016 THE ANEURYSM MEASURED 62.7MM. ON (B)(6) 2018 THE ANEURYSM MEASURED 77.5MM. ON (B)(6) 2018 THE PATIENT EXHIBITED A TYPE A DISSECTION. AN AORTIC VALVE REPLACEMENT, ASCENDING AORTA REPLACEMENT, TOTAL ARCH REPLACEMENT AND DESCENDING AORTA REPLACEMENT WITH REMOVAL OF IMPLANTS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE, BUT THE POST-OPERATIVE COURSE WAS DESCRIBED AS COMPLICATED. ON (B)(6) 2018 THE PATIENT EXPIRED.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 8426937 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2016 A PATIENT UNDERWENT TREATMENT OF A 60MM THORACIC AORTIC ANEURYSM, ZONE 3, WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE IN OCTOBER, 2018 THE PATIENT WAS HOSPITALIZED FOR ANEURYSM ENLARGEMENT NOTED ON CT TO MEASURE 6.5CM. THE ANEURYSMAL REGION STARTED AT THE LEVEL OF A PREVIOUSLY IMPLANTED THORACIC AORTIC STENT AND EXTENDED DISTALLY TO THE AORTIC BIFURCATION. THE ANEURYSM INVOLVED THE CELIAC AXIS, SUPERIOR MESENTERIC ARTERY AND HER SINGLE RIGHT SIDE RENAL ARTERY AND UNDERWENT AN ADDITIONAL ENDOVASCULAR PROCEDURE WITH ADDITIONAL STENT PLACEMENT. SHE WAS REFERRED TO MAYO CLINIC FOR ENDOVASCULAR REPAIR USING A FENESTRATED BRANCHED STENT GRAFT. ON (B)(6), 2018, THE PATIENT UNDERWENT ENDOVASCULAR PLACEMENT OF A BRANCHED FENESTRATED DEVICE, FOR AN EXTENT TYPE 2 THORACOABDOMINAL AORTIC ANEURYSM USING A PATIENT SPECIFIC DIRECTIONAL BRANCHED STENT GRAFT. A PROXIMAL CUSTOM LOW-PROFILE THORACIC STENT GRAFT, 46MM X 32MM X 210MM COMPONENT WAS PLACED WITH 3 DIRECTIONAL BRANCHES. THE CELIAC AXIS AND SUPERIOR MESENTERIC ARTERY WERE BOTH BRANCHED WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE RENAL ARTERY WAS BRANCHED WITH A BOTH A GORE®

  Patient problems: Aneurysm

  MAUDE report 8366611 ↗
• InjuryJan 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, MEASURING 64MM, IN ZONE 0, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO THE AORTIC COMPONENT. A GORE® DRYSEAL FLEX SHEATH WAS UTILIZED FOR ACCESS. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 A TYPE III ENDOLEAK WAS DISCOVERED. ON (B)(6) 2018 A TYPE II ENDOLEAK WAS DISCOVERED. THE MAXIMUM AORTIC DIAMETER WAS 69MM. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8243027 ↗
• InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE (B)(6) STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2017, PRE-IMPLANTATION IMAGING IDENTIFIED AN ASCENDING THORACIC AORTIC DISSECTION (ZONE 0) WITH A REPORTED TOTAL TREATMENT LENGTH OF 32.6 CM. ADDITIONALLY, SIGNIFICANT THROMBUS WAS IDENTIFIED AT THE DISTAL IMPLANTATION SITE. ON (B)(6) 2017, THE PATIENT UNDERWENT SUCCESSFUL REVASCULARIZATION OF THE HEAD VESSELS, CONSISTING OF RIGHT CAROTID TO LEFT CAROTID AND LEFT CAROTID TO LEFT SUBCLAVIAN ARTERY BYPASS PROCEDURES. ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE THORACIC DISSECTION, PROXIMAL TO THE BRACHIOCEPHALIC TRUNK AND DISTAL TO THE SINOTUBULAR JUNCTION, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC123720C/16282141 AND TSB121506C/14424573) AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU454520/16449009). FOLLOW UP IMAGES DATED (B)(6) 2017, REVEALED AN INFECTED FEM-FEM BYPASS GRAFT. THE GRAFT WAS EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT PRESENTED WITH BACTEREMIA. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A CHRONICALLY INFECTED AORTIC GRAFT.

  Patient problems: Vascular Dissection

  MAUDE report 8061520 ↗
• DeathNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2017, PRE-IMPLANTATION IMAGING IDENTIFIED AN ASCENDING THORACIC AORTIC DISSECTION (ZONE 0) WITH A REPORTED TOTAL TREATMENT LENGTH OF 32.6 CM. ADDITIONALLY, SIGNIFICANT THROMBUS WAS IDENTIFIED AT THE DISTAL IMPLANTATION SITE. ON (B)(6) 2017, THE PATIENT UNDERWENT SUCCESSFUL REVASCULARIZATION OF THE HEAD VESSELS, CONSISTING OF RIGHT CAROTID TO LEFT CAROTID AND LEFT CAROTID TO LEFT SUBCLAVIAN ARTERY BYPASS PROCEDURES. ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE THORACIC DISSECTION, PROXIMAL TO THE BRACHIOCEPHALIC TRUNK AND DISTAL TO THE SINOTUBULAR JUNCTION, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC123720C/16282141 AND TSB121506C/14424573) AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU454520/16449009). IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH A POSSIBLE AORTOPULMONARY FISTULA. THEN HAD AN ACUTE PULMONARY HEMORRHAGE AND EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 8060267 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC TYPE B DISSECTION (ZONE 2) USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2018, THERE WAS AN ASCENDING AORTA ANEURYSM RUPTURE THAT COMPROMISED THE BLOOD PRESSURE. THE PHYSICIAN CHOSE TO DO A HEMIARCH AND ASCENDING ARCH REPLACEMENT. 2100 ML OF BLOOD WAS GIVEN DURING THE PROCEDURE DUE TO BLOOD LOSS. THE DAY AFTER THE PROCEDURE THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY AND NEEDED ACUTE DIALYSIS TREATMENT, IT IS ONGOING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 7760415 ↗
• DeathJun 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN AORTIC DISSECTION. THE PATIENT HAD A PRIOR IMPLANTATION OF A COOK ALPHA DEVICE. THE TREATMENT WAS A COMBINED ENDOVASCULAR AND OPEN PROCEDURE. A GORE® TAG® THORACIC ENDOPROSTHESIS WAS ADVANCED AND DEPLOYED. A VASCUTEK THORAFLEX DEVICE WAS ALSO ADVANCED AND DEPLOYED. THE BRANCHES OF THE THORAFLEX DEVICE WERE EXTENDED WITH GORE® PROPATEN® VASCULAR GRAFTS TO THE VISCERAL ARTERIES: SMA, AND BOTH RENALS. IMMEDIATELY FOLLOWING BALLOONING OF THE AORTIC DEVICES, THE PATIENT HAD A CARDIAC ARREST. DEFIBRILLATION AND CHEST COMPRESSIONS WERE PERFORMED. THE PATIENT WAS STABILIZED AND TAKEN TO RECOVERY. ALL DEVICES WERE PATENT AND FUNCTIONING AT THE CLOSE OF THE PROCEDURE, HOWEVER THE PATIENT'S CONDITION WAS CONSIDERED DIRE. ON (B)(6) 2018 THE PATIENT EXPIRED DUE TO DISSEMINATED INTRAVASCULAR COAGULATION.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7653760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm