GORE TAG Conformable Thoracic Endoprosthesis TGU373715Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00733132618187), received between Sep 19, 2018 and Mar 6, 2025 — classified as 1 death, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE ANEURYSM CONTINUED TO GROW (SIZE UNKNOWN). THE PHYSICIAN SUSPECTED THAT THERE WAS A TYPE 1A OR A TYPE 3 ENDOLEAK; HOWEVER, IT WAS DIFFICULT TO GET VISUALIZATION OF IT ON THE ANGIOGRAM. THERE WAS A BLUSH OF CONTRAST ON THE CT SCAN. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE UTILIZING THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS IN ZONE 3. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE REPORTED EVENT TO OCCUR.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21538186 ↗
• InjuryMay 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON A (B)(6) 2018, A PATIENT UNDERWENT TREATMENT OF A ZONE 2 THORACIC AORTIC DISSECTION WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. CORE LAB PRE-TREATMENT IMAGING ON (B)(6) 2018, SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 52.5MM. ON (B)(6)2018 A FALSE LUMEN PERFUSION DISTAL TO THE DEVICE WAS NOTED. THE MAXIMUM AORTIC DIAMETER WAS 62MM. ON (B)(6) 2018 A REINTERVENTION OCCURRED WHEREBY A SECOND CTAG DEVICE (TGU373710/UNKNOWN) WAS IMPLANTED AND AN EMBOLIZATION PROCEDURE OF THE INTERCOSTAL VESSELS WITH A PLUG WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2018 TO (B)(6) 2020, CORE LAB FOLLOW UP IMAGING REVEALED THAT THE MAXIMUM AORTIC DIAMETER WITHIN TREATED SEGMENT WAS INCREASED IN SIZE FROM 62MM TO 69MM. FROM (B)(6) 2018 TO (B)(6) 2020, CORE LAB FOLLOW UP IMAGING REVEALED THAT THE MAXIMUM FALSE LUMEN DIAMETER DECREASED FROM 59.1MM TO 23.4MM. ON (B)(6) 2020, A DISTAL PERSISTENT FALSE LUMEN PERFUSION WAS REPORTED. ON (B)(6) 2020, THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE. PLEASE NO

  Patient problems: Vascular Dissection

  MAUDE report 16969633 ↗
• InjuryNov 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK AND WISHES TO UNDERGO REINTERVENTION. THE PHYSICIAN STATED THAT HIS TREATMENT PLAN IS TO BRING THE PATIENT BACK IN FOR A DEBRANCHING AT A FUTURE DATE. NO DATE HAS BEEN SCHEDULED AS THE PATIENT HAS SOME OTHER UNKNOWN ISSUES THAT REQUIRE ATTENTION PRIOR TO REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 15799423 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MID-DESCENDING THORACIC AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG A/C). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK FROM THE PREVIOUSLY PLACED DEVICE AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE TAG DEVICE WAS EXTENDED TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A CONTINUED TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE DEVICE WAS PLACED TO PARTIALLY COVER THE LEFT SUBCLAVIAN ARTERY DUE TO THE CONTINUED TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT A CAROTID-CAROTID AND CAROTID-SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596238 ↗
• InjuryAug 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 60 MM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016 COIL EMBOLIZATION WAS PERFORMED TO TREAT A PERSISTENT ENDOLEAK OF UNKNOWN TYPE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319522 ↗
• InjuryJul 30, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B UNCOMPLICATED AORTIC DISSECTION USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS NOTED THAT THE PROXIMAL PORTION OF THE PROXIMAL DEVICE WAS DEPLOYED IN ZONE 1 DISTAL TO THE PATIENT'S BRACHIOCEPHALIC ARTERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON AN UNKNOWN DATE A TYPE II ENDOLEAK WAS IDENTIFIED ORIGINATING FROM THE PATIENT'S LEFT SUBCLAVIAN ARTERY (LSA). ON (B)(6) 2016 THE PATIENT WAS ADMITTED FOR PRE-OPERATIVE HYDRATION FOR AN LSA COIL EMBOLIZATION PROCEDURE TO TREAT THE TYPE II ENDOLEAK. A LEFT BRACHIAL APPROACH WAS USED AND MULTIPLE TERUMO AZUR COILS WERE PLACED IN THE LSA. IT WAS REPORTED THAT FINAL ANGIOGRAPHY CONFIRMED VERY MINIMAL FLOW INTO THE LSA. NO COMPLICATIONS WERE REPORTED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256462 ↗
• InjuryJul 8, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED THAT PROXIMALIZATION OF THE GRAFT, AS SUGGESTED BY THE PHYSICIAN, HAS NOT BEEN PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 12139979 ↗
• InjuryJul 6, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015 THE PATIENT UNDERWENT TREATMENT OF A 60 MM DESCENDING THORACIC AORTIC ANEURYSM OF CHRONIC TYPE B DISSECTION ETIOLOGY WHEREBY TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED IN ZONE 3 OF THE PROXIMAL DESCENDING THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017 THE PATIENT UNDERWENT CEREBRAL DEBRANCHING OF THE ASCENDING AORTA DUE TO A TYPE B DISSECTION. ON (B)(6) 2017 A TYPE A AORTIC DISSECTION WAS REPORTED. IT IS UNKNOWN WHETHER THIS DISSECTION WAS NEW, OR A CONTINUATION OF THE TYPE B DISSECTION. THE DISSECTION WAS TREATED BY MEANS OF OPEN REPAIR AND REPLACEMENT OF THE ASCENDING AORTA THROUGH A RE-DO STERNOTOMY. ON (B)(6) 2020 ANEURYSMAL DEGENERATION OF THE TYPE A AORTIC DISSECTION WITH ENLARGED PARAVISCERAL AORTA WAS REPORTED. IT WAS REPORTED THAT THE AORTIC DISSECTION HAD DILATED OVER TIME AND THE PATIENT HAD A TYPE IV THORACOABDOMINAL ANEURYSM WITH DISSECTION OF THE BILATERAL RENAL ARTERIES AND MULTIPLE FENESTRATION CAUSING FALSE LUMEN EXPANSION. IT WAS NOTED THAT THE PATIENT POSSESSED MULTIPLE COMORBIDITIES

  Patient problems: Vascular Dissection

  MAUDE report 12125392 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED, AND THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN HAD NO OPINION REGARDING THE CAUSE OF THE ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 10667019 ↗
• InjuryMay 23, 2020Adverse 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 PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, UNKNOWN MAXIMUM AORTIC DIAMETER, ZONE 2, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 A CT REVEALED A TYPE II ENDOLEAK. THE MAXIMUM AORTIC DIAMETER WAS 59.1MM. ON (B)(6) 2018 A REINTERVENTION OCCURRED WHEREBY A SECOND CTAG DEVICE WAS IMPLANTED AND SEVERAL EMBOLIZATION PLUGS WERE PLACED IN THE FALSE LUMEN. ON (B)(6) 2018 A CT REVEALED THE MAXIMUM FALSE LUMEN DIAMETER WAS 48.2MM. ON (B)(6) 2019 THE MAXIMUM FALSE LUMEN DIAMETER WAS 53.2MM. ON (B)(6) 2020 PERSISTENT FALSE LUMEN PERFUSION WAS REPORTED. THIS FALSE LUMEN PERFUSION WAS REPORTEDLY COMING FROM THE SAME AREA AS THE PREVIOUS INCIDENCE. A REINTERVENTION IS PLANNED TO TAKE PLACE WHEN STATUS HAS CALMED DOWN. THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 10084640 ↗
• MalfunctionNov 22, 2019Entrapment of Device; Patient-Device Incompatibility; Device Damaged by Another Device; Entrapment of Device; Patient-Device Incompatibility; Device Damaged by Another Device

  THE DEVICE WAS RETURNED FOR EVALUATION. THE ENGINEERING EVALUATION STATED: THERE IS NO LEADING OLIVE ATTACHED TO THE LEADING END OF THE CATHETER. THE STIFFENING WIRE REMAINED WITHIN THE DELIVERY CATHETER. THE DELIVERY CATHETER NEAR THE EXPECTED LOCATION OF THE OLIVE DEMONSTRATES CHARACTERISTICS OF A TENSILE FAILURE, WHICH IS CONSISTENT WITH THE EVENT DESCRIPTION THAT THE LEADING OLIVE DETACHED. THE DEPLOYMENT LINES REMAINED WITHIN THE DELIVERY CATHETER AND MEASURED APPROXIMATELY 127.6 CM; CONSISTENT WITH LENGTHS EXPECTED FOR THIS DEVICE SIZE. NO DAMAGE WAS OBSERVED. THE TRAILING OLIVE LEASH LINE HOLE INDICATES DAMAGE CONSISTENT WITH A TRAILING LEASH LINE BEING FORCEFULLY REMOVED. THE ROOT CAUSE FOR THE LEADING OLIVE BREAK IS A TENSILE BREAK DUE TO RESISTIVE FORCE. THE SOURCE OF RESISTIVE FORCE IS UNKNOWN BUT POTENTIALLY CAUSED BY TORTUOUS ANATOMY OR PREVIOUSLY IMPLANTED DEVICES.

  Patient problems: Aortic Dissection; Device Embedded In Tissue or Plaque

  MAUDE report 9362182 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015, A PATIENT UNDERWENT TREATMENT FOR A 75.5MM SACCULAR ANEURYSM OF THE PROXIMAL DESCENDING THORACIC AORTA USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. REPORTEDLY, FROM (B)(6) 2015 TILL (B)(6) 2019, THE FOLLOW UP COMPUTED TOMOGRAPHY (CT) OBSERVED AN INDETERMINATE ENDOLEAK. ADDITIONALLY, A CT SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 75MM TO 80MM. ON (B)(6) 2019, THE ENDOLEAK WAS SUSPECTED TO BE A TYPE II ENDOLEAK. THE CAUSE/ORIGIN OF ENDOLEAK WILL BE DETERMINED AT THE NEXT VISIT. NO TREATMENT WAS REQUIRED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 9360028 ↗
• InjuryNov 18, 2019Microbial Contamination of Device; Microbial Contamination of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A RESIDUAL DESCENDING THORACIC AORTIC DISSECTION, ZONE 2 WITH ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND THREE INVESTIGATIONAL GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED WITH A POLY-MICROBIAL BACTEREMIA + S.MITIS, SAPROPHYTIC NEISSERIA INFECTION. THE INFECTION WAS TREATED WITH DRUG THERAPY VIA A PICC LINE. THE INFECTION WAS NOT THOUGHT TO BE DEVICE RELATED. THERE WAS NO OBVIOUS SOURCE AND THE PATIENT WAS TO FOLLOW-UP WITH AN INFECTIOUS DISEASE PROVIDER. AT THE THIRTY DAY FOLLOW-UP APPOINTMENT THE PATIENT WAS DOING WELL. HE STILL HAD HIS PICC LINE IN PLACE TO COMPLETE HIS SIX WEEK DRUG THERAPY.

  Patient problems: Bacterial Infection

  MAUDE report 9338791 ↗
• InjuryJul 4, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC DISSECTION, DISTAL TO THE LEFT COMMON CAROTID ARTERY OSTIUM AND PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC123720C/17586918 AND TSB121506C/16287330) AND TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU343410/17951220-MOST ADJACENT TO AORTIC COMPONENT AND TGU373715/17977144-DISTAL EXTENSION). ACCORDING TO THE REPORT, THE TOTAL TREATMENT LENGTH WAS 14 CM WITH THE LEFT SUBCLAVIAN ARTERY THE INTENDED BRANCH VESSEL TO BE TREATED. THE PATIENT TOLERATED THE PROCEDURE. DURING THIS PROCEDURE, EMBOLIZATION COILS WERE IMPLANTED AT THE DISTAL ENDS OF THE CTAG DEVICES TO OCCLUDE THE FALSE LUMEN. THE COILS EXTEND DISTAL TO THE RIGHT RENAL ARTERY. THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED SEGMENT WAS 61.6MM. IT WAS REPORTED THAT POST IMPLANT IMAGES REVEALED A TYPE II ENDOLEAK, WITH NO ANEURYSM GROWTH AND NO REINTERVENTION. THE DATABASE HAS BEEN UPDATED. THE DATE THE TYPE II ENDOLEAK WAS DISCOVERED BY IMAGES WAS (B)(6) 2018. ON (B)(6) 2018 A CT SCAN SHOWED THE MAXIMUM AORTIC DIAMETER WITHIN THE T

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8762749 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT TREATMENT OF A 60 MM DESCENDING THORACIC AORTIC ANEURYSM OF CHRONIC TYPE B DISSECTION ETIOLOGY WHEREBY TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED IN ZONE 3 OF THE PROXIMAL DESCENDING THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, FOLLOW UP IMAGING SHOWED THE AORTA MEASURED 57 MM. ON (B)(6) 2016, FOLLOW UP IMAGING IDENTIFIED A ¿PERSISTENT ENDOLEAK,¿ LATER REPORTED TO BE A DISTAL TYPE I ENDOLEAK. HOWEVER, IT WAS REPORTED THE ¿ENDOLEAK¿ WAS INDICATED TO BE A RESULT OF THE PRE-EXISTING DISSECTION AND WAS REPORTEDLY CAUSED BY PERSISTENT FLOW INTO THE FALSE LUMEN. IT WAS FURTHER REPORTED THE PERSISTENT FALSE LUMEN PERFUSION ORIGINATED BELOW THE TREATED SEGMENT OF THE AORTA IN AN UNTREATED AREA. THE ¿ENDOLEAK¿ WAS REPORTEDLY NOT RELATED TO THE GORE DEVICES, AND THERE WERE NO ISSUES OR ALLEGATIONS OF DEFICIENCY RELATED TO THE GORE DEVICES. IT WAS REPORTED NO ANEURYSM OR FALSE LUMEN ENLARGEMENT WAS IDENTIFIED. ON (B)(6) 2016, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE ENDOLEAK. IT WAS REPORTED THE COIL EMBOLIZATION DID NOT ENTIRELY RESOLVE THE PERSISTENT FALSE LUMEN PERFUSION. THE PATIENT WILL REPORTEDLY CO

  Patient problems: Vascular Dissection

  MAUDE report 8761493 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT THE TREATMENT RANGE EXTENDED TO THE PATIENT'S BRACHIOCEPHALIC ARTERY. THE PATIENT'S LEFT SUBCLAVIAN ARTERY WAS PLUGGED. CALCIFICATION WAS NOTED IN THE PATIENT'S AORTIC ARCH. REPORTEDLY THE PROCEDURE WAS SUCCESSFUL. NO ENDOLEAKS WERE NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019 THE PATIENT PRESENTED WITH LEFT LEG WEAKNESS. THE PATIENT WAS COHERENT WITH NO REPORTED COGNITIVE ISSUES. A POTENTIAL STROKE WAS SUSPECTED. AN MRI CONFIRMED THAT THE PATIENT SUFFERED MINOR STROKES REPORTEDLY RELATED TO MANIPULATION IN THE AORTIC ARCH DURING THE PROCEDURE. THE PATIENT HAD CONTINUING MODERATE LEFT LEG WEAKNESS FOLLOWING THE MRI. ON (B)(6) 2019 IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED WITH FULL NEUROLOGICAL RECOVERY.

  Patient problems: Claudication; Stroke/CVA

  MAUDE report 8733164 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CTA) IMAGES DATED (B)(6) 2019, REVEALED AN UNKNOWN ENDOLEAK. POSSIBLY A TYPE II ENDOLEAK OR A DISTAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. NO REINTERVENTION HAS BEEN PLANNED, THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8654304 ↗
• DeathMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE ESOPHAGUS WAS DIVERTED DURING THE REINTERVENTION ON (B)(6) 2019. WHILE WAITING TO GET THE GRAFTS EXPLANTED, THE PATIENT EXPIRED (EXACT DATE IS NOT KNOWN). CAUSE OF DEATH IS DUE TO THE ESOPHAGUS COMPLICATIONS AND INFECTION. (B)(6) 2019 WILL BE USED AS DATE OF DEATH, SINCE ACTUAL DATE IS UNKNOWN, BUT THE PATIENT EXPIRED AFTER THE REINTERVENTION.

  Patient problems: Vascular Dissection

  MAUDE report 8599928 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT TREATMENT OF A 60 MM DESCENDING THORACIC AORTIC ANEURYSM OF CHRONIC TYPE B DISSECTION ETIOLOGY WHEREBY TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED IN ZONE 3 OF THE PROXIMAL DESCENDING THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, FOLLOW UP IMAGING SHOWED THE AORTA MEASURED 57 MM. ON (B)(6) 2016, FOLLOW UP IMAGING IDENTIFIED A ¿PERSISTENT ENDOLEAK,¿ LATER REPORTED TO BE A DISTAL TYPE I ENDOLEAK. HOWEVER, IT WAS REPORTED THE ¿ENDOLEAK¿ WAS INDICATED TO BE A RESULT OF THE PRE-EXISTING DISSECTION AND WAS REPORTEDLY CAUSED BY PERSISTENT FLOW INTO THE FALSE LUMEN. IT WAS FURTHER REPORTED THE PERSISTENT FALSE LUMEN PERFUSION ORIGINATED BELOW THE TREATED SEGMENT OF THE AORTA IN AN UNTREATED AREA. THE ¿ENDOLEAK¿ WAS REPORTEDLY NOT RELATED TO THE GORE DEVICES, AND THERE WERE NO ISSUES OR ALLEGATIONS OF DEFICIENCY RELATED TO THE GORE DEVICES. IT WAS REPORTED NO ANEURYSM OR FALSE LUMEN ENLARGEMENT WAS IDENTIFIED. ON (B)(6) 2016, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE ENDOLEAK. IT WAS REPORTED THE COIL EMBOLIZATION DID NOT ENTIRELY RESOLVE THE PERSISTENT FALSE LUMEN PERFUSION. THE PATIENT WILL REPORTEDLY CO

  Patient problems: Vascular Dissection

  MAUDE report 8589229 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, MAXIMUM AORTIC DIAMETER 52.5MM, ZONE 2, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 A CT REVEALED A TYPE II ENDOLEAK. THE MAXIMUM AORTIC DIAMETER WAS 59.1MM. ON (B)(6) 2018 A REINTERVENTION OCCURRED WHEREBY A SECOND CTAG DEVICE WAS IMPLANTED AND SEVERAL EMBOLIZATION PLUGS WERE PLACED IN THE FALSE LUMEN. ON (B)(6) 2018 A CT REVEALED A TYPE II ENDOLEAK TO BE ASSOCIATED WITH THE CTAG DEVICE. THE MAXIMUM AORTIC DIAMETER WAS 60.5MM THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8366451 ↗
• InjuryDec 9, 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 UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, WITH MAXIMUM AORTIC DIAMETER OF 48.6MM USING TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 THE PATIENT¿S CT REVEALED THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED SEGMENT WAS 54.9MM. A TYPE II ENDOLEAK INVOLVING THE CTAG DEVICE, WAS SEEN ORIGINATING FROM AN INTERCOSTAL ARTERY. AN INDETERMINATE ENDOLEAK WAS ALSO SEEN.

  Patient problems: Aneurysm; Aortic Dissection

  MAUDE report 8145130 ↗
• InjuryOct 22, 2018Compatibility Problem; Compatibility Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM AND TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK CAUSED BY DEGENERATION OF THE DISTAL DESCENDING THORACIC AORTA. TWO ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED, TO EXTEND COVERAGE BOTH PROXIMALLY AND DISTALLY. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. NO ANEURYSM ENLARGEMENT WAS REPORTED.

  Patient problems: Discharge

  MAUDE report 7992671 ↗
• InjurySep 19, 2018Malposition of Device; Malposition of Device

  ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THE PHYSICIAN INTENDED TO IMPLANT THE DEVICE JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA). REPORTEDLY, DURING DEPLOYMENT, THE DEVICE ¿JUMPED¿ FORWARD 3CM AND COMPLETELY COVERED THE LEFT SUBCLAVIAN ARTERY AND THE LEFT COMMON CAROTID ARTERY (LCC). IT WAS REPORTED THE CAUSE OF THE DEVICE JUMPING IS UNKNOWN. IT WAS REPORTED THE PHYSICIAN INFLATED A BALLOON INSIDE OF THE DEVICE AND PULLED THE DEVICE DISTALLY INTO THE INTENDED LOCATION, NO LONGER COVERING ANY VESSELS. THE PROCEDURE CONCLUDED WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED. FINAL ANGIOGRAPHY SHOWED COMPLETE EXCLUSION OF THE ANEURYSM AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890853 ↗

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-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · 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-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm