GORE TAG Conformable Thoracic EndoprosthesisRecalls & reported problems across all models

We found 20 models of GORE TAG Conformable Thoracic Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between May 10, 2018 and Nov 17, 2025 — classified as 17 deaths, 135 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE TAG Conformable Thoracic Endoprosthesis problems

GORE TAG Conformable Thoracic Endoprosthesis models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE TAG Conformable Thoracic Endoprosthesis TGU373715

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death23 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU454520

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths21 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU343415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths17 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU404020

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU343420

  System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU454515

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths10 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU313115

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU373710

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death7 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU404010

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU404015

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU343410

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU373720

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths6 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU212110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU262610

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death4 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU262110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU282810

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU454510

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU313110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE TAG Conformable Thoracic Endoprosthesis TGU312610

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Conformable Thoracic Endoprosthesis TGU282815

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE TAG Conformable Thoracic Endoprosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Adverse 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, PATIENT UNDERWENT AN THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS. ON (B)(6) 2025, PATIENT CALLED STATING THE DEVICE WAS DEFECTIVE ACCORDING TO HIS CURRENT PHYSICIANS AND THAT IT NEEDS TO BE EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568411 ↗
• InjurySep 15, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING ANEURYSM, UTILIZING CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS OBSERVED DURING A FOLLOW-UP IMAGING. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS ENDOLEAK IN WHICH ADDITIONAL DEVICES (GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS) WERE IMPLANTED PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION OR IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23059740 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PENETRATING AORTIC ULCER WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 23.1MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6)2013 TO (B)(6) 2018 THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 25MM TO 41MM. REPORTEDLY, NO TREATMENT WAS PERFORMED.

  Patient problems: Aneurysm expansion

  MAUDE report 22391672 ↗
• 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 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 ↗
• MalfunctionAug 9, 2024Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH 31MM X 15CM GORE® TAG THORACIC ENDOPROSTHESIS (CTAG DEVICE) TO TREAT THORACIC AORTIC ANEURYSM. THE DISTANCE BETWEEN THE PATIENT'S ANEURYSM AND LEFT SUBCLAVIAN ARTERY IS 0.8MM. THEREFORE, THE PHYSICIAN PERFORMED A BYPASS FROM THE LEFT COMMON CAROTID ARTERY TO THE LEFT SUBCLAVIAN ARTERY TO EXTENT LANDING ZONE. A LIFETECH STENT WAS IMPLANTED PRIOR TO CTAG DEVICE IN THE SAME PROCEDURE. THE CTAG DEVICE WAS ADVANCED TO DISTAL LEFT COMMON CAROTID ARTERY. AFTER CONFIRMING THE POSITION WAS PRECISE VIA IMAGING, THE PHYSICIAN DEPLOYED CTAG DEVICE. THE DEPLOYMENT LINE WAS TOTALLY PULLED OUT AND THE STENT WAS SUCCESSFULLY EXPANDED. DURING WITHDRAWING DELIVERY SYSTEM, A STRONG RESISTANCE WAS FELT, AND THE DELIVERY SYSTEM COULDN'T BE REMOVED. THE PHYSICIAN TRIED TO EXCHANGE GUIDEWIRES AND PULL WITH THE SNARE, BUT THE DELIVERY SYSTEM STILL COULDN'T BE REMOVED. FINALLY, THE PHYSICIAN PULLED DELIVERY SYSTEM WITH STRONG FORCE, IT WAS REMOVED OUT. HOWEVER, THE SLEEVE WHICH SHOULD HAVE REMAINED IMPLANTED BETWEEN THE STENT AND THE VESSEL WALL WAS REMOVED OUT WITH DELIVERY SYSTEM. THE STENT WAS MIGRATED TO DESCENDING AORTA. ANOTHER DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946900 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG/AC) TO TREAT ASCENDING AORTIC ANEURYSM. THE PATIENT HAD ASCENDING AORTIC ANEURYSM AND PERFORMED A HEART TRANSPLANT PREVIOUSLY. DURING THE PROCEDURE, A TGMR373710 CTAG/AC WAS IMPLANTED AND DEPLOYED AS PLANNED. DUE TO THE LARGE SIZE OF THE ANEURYSM, THE STENT MOVED BACKWARDS AFTER IMPLANTATION. THE PHYSICIAN CONTINUED TO IMPLANT CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (TGU4545110) TO RELINE THE TGMR373710. THE PATIENT TOLERATED THE PROCEDURE AND TRANSFERRED TO ICU FOR MONITOR. ON JULY 12, CLINICIAN FEED BACKED THAT THE PATIENT HAD CEREBRAL INFARCTION. THE PHYSICIAN SUSPECTED IT MAY RELATE TO PATIENT'S CONDITION, NOT TO THE PRODUCT.

  Patient problems: Neurogenic Shock

  MAUDE report 19835618 ↗
• InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM USING A NON-GORE DEVICE. ON (B)(6), 2015, A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE WAS DONE TO TREAT A ZONE 4 DESCENDING THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU404020/ 14185643). THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6), 2015. REPORTEDLY, PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 65MM. THE FOLLOW UP CTA ON (B)(6) 2017, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 61MM. ON (B)(6), 2017, THE PATIENT UNDERWENT AN ADDITIONAL ZONE 2 DESCENDING THORACIC AORTIC ANEURYSM TREATMENT WITH A PROXIMAL TYPE I ENDOLEAK FROM THE PREVIOUS REPAIR USING A GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ADDITIONALLY, THE PATIENT UNDERWENT REVASCULARIZATION PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6), 2017. ON (B)(6), 2017, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 33MM.

  Patient problems: Clinical Endoleak

  MAUDE report 19347765 ↗
• InjuryMay 17, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2016, A PATIENT UNDERWENT TREATMENT OF A TYPE B UNCOMPLICATED AORTIC DISSECTION WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2016, A CTA REVEALED THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 51MM. ON (B)(6) 2016, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. IT WAS UNKNOWN WHAT DEVICE WAS INVOLVED IN A TYPE I ENDOLEAK. THE CAUSE OF ENDOLEAK WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER WAS NOT AVAILABLE. REPORTEDLY, ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE AND AN ADDITIONAL ENDOGRAFT (UNKNOWN) WAS IMPLANTED. PER MEDICAL DEVICE TRACKING, NO ADDITIONAL GORE DEVICES WERE RECORDED. REPORTEDLY, OVER TIME THE ANEURYSMAL SIZE GREW TO 59 MM. FROM (B)(6) 2017 TO (B)(6) 2018 CTA REVEALED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 54MM TO 74MM. ON (B)(6) 2017, THE COIL EMBOLIZATION OF OUTFLOW VESSEL TO THORACIC AORTA FALSE LUMEN WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT BE CONTINUED TO HAVE AORTIC ENLARGEMENT. REPORTEDLY, ON (B)(6) 2018, THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR DUE TO THE ANEURYSM ENLARGEMENT. THE INITIAL ENDOG

  Patient problems: Aneurysm expansion; Pseudoaneurysm; Unspecified Infection

  MAUDE report 19347707 ↗
• InjuryNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343415/10456518). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE ENDOLEAK AND A SNORKEL PROCEDURE WAS PERFORMED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) WAS DEPLOYED WITHIN THE LEFT COMMON CAROTID AND THE ORIGINAL DEVICES WERE RELINED WITH THREE ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. NO ANEURYSM ENLARGEMENT WAS REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 18243192 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 TYPE B DISSECTION WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. CORE LAB PRE-TREATMENT IMAGING ON (B)(6) 2019, SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 67.2 MM. FROM (B)(6) 2019 TO (B)(6) 2022, THE CORE LAB IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION DECREASED IN SIZE FROM 63MM TO 56MM. REPORTEDLY, ON (B)(6) 2023, A WORSENING OF THE THORACOABDOMINAL DILATION WAS NOTICED. ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE AND AN ABDOMINAL FENESTRATED VISCERAL AORTIC ENDOGRAFT WAS PLACED TO EXTEND THE REPAIR INTO THE ABDOMINAL AORTA DUE TO THE DISTAL DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vascular Dissection

  MAUDE report 17831697 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 9, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM PROXIMAL TO THE BRACHIOCEPHALIC TRUNK, DISTAL TO THE SINOTUBULAR JUNCTION (ZONE 0) WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ON (B)(6) 2018, PRE-TREATMENT IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 66MM. FROM ON (B)(6) 2018 TILL ON (B)(6) 2019 THE ANEURYSM WAS STABLE 59MM. FROM ON (B)(6) 2020 TILL ON (B)(6) 2021, THE MAXIMUM ANEURYSM/ LESION INCREASED IN SIZE FROM 53MM TO 62 MM. ACCORDING TO THE PHYSICIAN, THERE WAS NO ENDOLEAK FOUND ON CT IMAGES. THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN. THE EVENT IS ONGOING. NO TREATMENT WAS REPORTED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 16343338 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS. ON (B)(6) 2022, DURING A FOLLOW UP, THE PHYSICIAN DISCOVERED A PSEUDOANEURYSM AT THE PROXIMAL END OF THE BARE STENT ON THE LATERAL SIDE OF THE CTAG DEVICE. THE PHYSICIAN BELIEVES THE PSEUDOANEURYSM MAY BE RELATED TO THE BARE STENT. REPORTEDLY, THE PHYSICIAN PLANS TO DO A REINTERVENTION. IMAGING EVALUATION: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING THERE APPEARS TO BE A PSEUDOANEURYSM AT THE LEVEL OF THE BARE METAL STENT PORTION OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PSEUDOANEURYSM IS ~11MM IN LENGTH. THE PSEUDOANEURYSM IS AT THE LOCATION WHERE THE BARE METAL STENT ROWS ONE AND A PORTION OF ROW TWO COME TOGETHER.

  Patient problems: Pseudoaneurysm

  MAUDE report 16018181 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports