GORE TAG Thoracic EndoprosthesisRecalls & reported problems across all models

We found 9 models of GORE TAG Thoracic Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Nov 28, 2025 — classified as 42 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 Thoracic Endoprosthesis problems

GORE TAG Thoracic Endoprosthesis models

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

• GORE TAG Thoracic Endoprosthesis TGT3115

  System, Endovascular Graft, Aortic Aneurysm Treatment
  10 reports
• GORE TAG Thoracic Endoprosthesis TGT3420

  System, Endovascular Graft, Aortic Aneurysm Treatment
  10 reports
• GORE TAG Thoracic Endoprosthesis TGT3715

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE TAG Thoracic Endoprosthesis TGT3720

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE TAG Thoracic Endoprosthesis TGT4020

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE TAG Thoracic Endoprosthesis TGT3415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE TAG Thoracic Endoprosthesis TGT2810

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Endoprosthesis TGT3110

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE TAG Thoracic Endoprosthesis TGT4520

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE TAG 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 28, 2025Adverse 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) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, A REINTERVENTION WAS PERFORMED FOR UNKNOWN INDICATION AT ANOTHER HOSPITAL. AN ADDITIONAL GORE STENT GRAFT WAS PLACED DISTAL TO THE PREVIOUS DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 23669777 ↗
• InjuryJun 15, 2025Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESIS DEVICES. BOTH TAG DEVICES WERE IMPLANTED IN THE DESCENDING AORTA AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2020, THE PATIENT UNDERWENT AORTIC ARCH REPLACEMENT AND OPEN STENT GRAFT PLACEMENT TO TREAT A PREEXISTING AORTIC ARCH ANEURYSM. ON (B)(6) 2025, CT EXAMINATION CONFIRMED THAT THE DISTAL TAG DEVICE HAD MIGRATED TO THE PROXIMAL SIDE, RESULTING IN A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). THE CTAGAC WAS DEPLOYED IN THE DISTAL SIDE TO TREAT THE DISTAL TYPE I ENDOLEAK. DURING THE DEPLOYMENT AND BALLOON MOLDING, THE DEVICE MOVED TO PROXIMAL SIDE, BUT NO ENDOLEAK WAS OBSERVED. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22208667 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTA ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, IT WAS REVEALED ANEURYSMALIZATION ON THE DISTAL SIDE OF THE DEVICE ON A CT IMAGE. THE PATIENT REPORTEDLY HAD POOR RENAL FUNCTION AND COULD NOT PERFORM ANGIOGRAPHY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, AN ADDITIONAL STENT GRAFT WAS PLACED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 22155468 ↗
• InjuryMar 24, 2025Material Puncture/Hole; Material Puncture/Hole

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN THORACOABDOMINAL AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESIS(CTAG). REPORTEDLY, TWO CTAG DEVICES WERE PLACED. ON (B)(6) 2025, A TYPE IIIB ENDOLEAK WAS OBSERVED ON THE COMPUTED TOMOGRAPHY(CT) IMAGING. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, TWO ADDITIONAL STENT GRAFT WAS PLACED, THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IT SEEMS LIKE THE EDGE SIDE OF THE CTAG THAT WAS IMPLANTED DISTALLY WAS STICKING INTO THE ANOTHER CTAG THAT WAS IMPLANTED PROXIMALLY, THAT MIGHT HAVE CAUSED ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 21684671 ↗
• InjuryMar 18, 2025Adverse 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) 2013, THE PATIENT UNDERWENT TREATMENT FOR A DESCENDING AORTIC ANEURYSM USING THE OPEN STENT TECHNIQUE WITH THE GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, DURING FOLLOW-UP, CONTRAST ENHANCEMENT REVEALED A SUSPECTED TYPE IIIB ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT INTERVENTION. INTRAOPERATIVE IMAGING DID NOT IDENTIFY A CLEAR ENDOLEAK. AN ADDITIONAL STENT GRAFT WAS PLACED TO RELINE THE EXISTING ONE. THE PHYSICIAN STATED AS FOLLOWS: THE INTRAOPERATIVE IMAGING DID NOT REVEAL A CLEAR ENDOLEAK. IF A LEAK IS DETECTED IN FUTURE FOLLOW-UP CT SCANS, THE POSSIBILITY OF A TYPE II ENDOLEAK WILL BE CONSIDERED.

  Patient problems: Insufficient Information

  MAUDE report 21628368 ↗
• InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURE OF TYPE B ACUTE AORTIC DISSECTION USING GORE® TAG® THORACIC ENDOPROSTHESIS. IN (B)(6) 2016, A REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK, ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY. ON AN UNKNOWN DATE, AN AORTA EXPANSION AT THE DISTAL SIDE OF THE DEVICE AND A DISTAL TYPE I ENDOLEAK WERE OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED, ADDITIONAL STENT GRAFTS WERE PLACED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21108795 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR TYPE B AORTIC DISSECTION AND IMPENDING RUPTURE OF THORACIC DESCENDING AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES (TAG). TWO TAGS WERE IMPLANTED SUCCESSFULLY (DISTAL TGT3115, PROXIMAL TGT3720). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION SHOWED ANEURYSM ENLARGEMENT (ANEURYSMALIZATION) ON THE PROXIMAL AND DISTAL ENDS OF THE TREATMENT AREA OF THE TAGS, RESPECTIVELY. THE ANEURYSM OF THE DISTAL SIDE WAS ESPECIALLY LARGE AND AN ADDITIONAL TREATMENT WAS INDICATED. ON (B)(6) 2024, AN ADDITIONAL STENT GRAFT WAS PLACED TO THE DISTAL OF THE PREVIOUS TAGS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE CONTRAST-ENHANCED CT SHOWED HETEROGENEOUS CONTRAST EFFECT OF THE ANEURYSM, WHICH MAY HAVE INDICATE INFECTION, INFLAMMATION, OR TUMOR. MOST LIKELY, IT WAS TUMOR INVASION BECAUSE THE BLOOD TEST WAS NEGATIVE FOR INFLAMMATION, THE PATIENT WAS TREATED FOR LUNG CANCER AT ANOTHER HOSPITAL, AND THE PET-CT PERFORMED AT ANOTHER HOSPITAL SHOWED FDG ACCUMULATION. THE PATIENT WAS RECEIVING TREATMENT WITH KEYTRUDA AND EXPECTED TO HAVE A CERTA

  Patient problems: Aneurysm expansion

  MAUDE report 20015383 ↗
• InjuryJan 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC ENDOPROSTHESIS FOR DESCENDING AORTIC ANEURYSM USING ELEPHANT TRUNK TECHNIQUE. ON (B)(6) 2023, TYPE IIIB ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY. IT WAS REPORTED THAT THE DATE OF ENDOLEAK ONSET IS UNKNOWN. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION. TWO ADDITIONAL STENT GRAFTS WERE DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYCISIAN STATED THE FOLLOWING. IT APPEARS THAT TEAR APPEARED IN THE GRAFT DUE TO FRICTION CAUSED BY THE PULSATION, RESULTING IN TYPE IIIB.

  Patient problems: Clinical Endoleak

  MAUDE report 18475710 ↗
• InjurySep 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AORTIC DISSECTION USING A GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AS A DISTAL STENT GRAFT-INDUCED NEW ENTRY TEAR (D-SINE) WAS FOUND BY A FOLLOW-UP CT SCAN. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADDITIONALLY IMPLANTED TO EXTEND THE TREATMENT AREA DISTALLY FOR APPROXIMATELY 3 CM. NO ENDOLEAK WAS FOUND. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE DISTAL FLARE OF THE DEVICE PROBABLY CAUSED THE D-SINE.

  Patient problems: Vascular Dissection

  MAUDE report 17760778 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2011, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A RETROGRADE TYPE A DISSECTION AND ULP USING THREE GORE® TAG® THORACIC ENDOPROSTHESES. AFTER ALL DEVICES WERE IMPLANTED, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO MONITOR THIS ENDOLEAK. ON AN UNKNOWN DATE, A FOLLOW-UP EXAM REVEALED THE PROXIMAL TYPE I ENDOLEAK AND THE FALSE LUMEN ENLARGEMENT. NO NEW ENTRY TEAR WAS FOUND IN FALSE LUMEN. IT WAS UNKNOWN IF THERE WAS PERSISTENT FALSE LUMEN PERFUSION. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED PROXIMALLY. THE ENDOLEAK WAS RESOLVED. IN ADDITION, IT WAS ALSO REPORTED THAT PHYSICIAN DID NOT REPORT ADDITIONAL INFORMATION ON CAUSE OF THE TYPE 1 ENDOLEAK AND THE FALSE LUMEN ENLARGEMENT OCCURRED DUE TO THE TYPE 1 ENDOLEAK.

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

  MAUDE report 17171259 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE. ON UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115/9042283, DISTAL-TGT3420/9077511). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS CONFIRMED THAT THE TGT3115 MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK. THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6) 2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR TREATMENT OF UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU343420J) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE

  Patient problems: Aneurysm expansion

  MAUDE report 17105076 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE. ON UNKNOWN DATE, TOTAL ARCH REPLACEMENT WAS PERFORMED USING A SURGICAL GRAFT. ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (PROXIMAL-TGT3115/9042283, DISTAL-TGT3420/9077511). THE PROXIMAL END OF THE TGT3115 WAS PLACED IN THE DISTAL ANASTOMOSIS OF THE SURGICAL GRAFT. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, IT WAS CONFIRMED THAT THE TGT3115 MIGRATED DISTALLY. THERE WAS AN UNKNOWN LEAK BETWEEN THE DISTAL ANASTOMOSIS AND THE TGT3115. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN ORDER TO DETERMINE THE ORIGIN OF THE LEAK, BUT IT WAS UNABLE TO DETERMINE THE EXACT ORIGIN OF THE LEAK. THE PHYSICIAN REPORTEDLY STATED THAT THE EXACT CAUSE OF THE LEAK WAS UNKNOWN. THE FLARE (THE PROXIMAL END) OF THE TGT3115 MIGHT HAVE CAUSED A DAMAGE TO THE SURGICAL GRAFT AND IT RESULTED IN A LEAK FROM THE SURGICAL GRAFT. ON (B)(6) 2018, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR TREATMENT OF UNKNOWN LEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU343420J) WAS IMPLANTED COVERING THE DISTAL ANASTOMOSIS OF THE

  Patient problems: Aneurysm expansion

  MAUDE report 17105041 ↗
• InjuryMay 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AFTER A TOTAL ARCH REPLACEMENT FOR STANFORD TYPE A AORTIC DISSECTION. 2 GORE® TAG® THORACIC ENDOPROSTHESES (TAG) WERE IMPLANTED FROM THE AORTIC ARCH TO THE DESCENDING AORTA. REPORTEDLY THE THORACIC ANEURYSM SIZE AT THE TIME OF INITIAL TREATMENT WAS 58.9 MM. ON AN UNKNOWN DATE IN (B)(6) 2021, FOLLOW-UP CT SCAN SHOWED THAT THE ANEURYSM SIZE HAD INCREASED TO 75.2 MM. FOLLOW-UP OBSERVATION WAS CONTINUED. ON (B)(6) 2023, FOLLOW-UP CT SCAN SHOWED THAT THE ANEURYSM SIZE HAD INCREASED TO 78.2 MM. IT WAS DETERMINED THAT THE ENLARGEMENT WAS DUE TO A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AND TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED PROXIMALLY. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16980107 ↗
• InjuryNov 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES WITH AN ELEPHANT TRUNK TECHNIQUE AFTER A TOTAL ARCH REPLACEMENT AND AN ELEPHANT TRUNK THAT WERE PERFORMED ON AUGUST 16, 2013. DURING THE TREATMENT, AFTER ALL STENT GRAFTS WERE IMPLANTED, A POSSIBLE DISTAL TYPE I ENDOLEAK OR A POSSIBLE TYPE II ENDOLEAK WAS OBSERVED. ADDITIONALLY TOUCH UP WAS PERFORMED AT THE DISTAL SIDE OF THE DISTAL STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, AN ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. DURING THE REINTERVENTION, AN ANGIOGRAPHY REVEALED NO LEAK. ADDITIONALLY, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED TO EXTEND PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE THOUGHT THAT INTRAOPERATIVE ANGIOGRAPHY WOULD REVEAL A LEAK THAT WAS CAUSING THE ANEURYSMAL ENLARGEMENT. AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO COVER THE ANASTOMOSIS SITE. REPORTEDLY, THERE WERE TWO TAG DEVICES THAT WERE IMPLANTED, BUT IT WAS UNKNOWN WHICH DEVICE WAS IM

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 15801360 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY REVEALED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). NO ENDOLEAK WAS OBSERVED DURING THE EXAMINATION. IT WAS REPORTED THE PATIENT ALSO DEVELOPED OCCASIONAL HEMOPTYSIS. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. AN INTRA-OPERATIVE ANGIOGRAPH SHOWED NO ENDOLEAK. TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG-AC) WERE IMPLANTED AS PROXIMAL AND DISTAL EXTENSION OF THE EXISTING GORE® TAG® THORACIC ENDOPROSTHESIS. AFTER TOUCH-UP BALLOONING WAS PERFORMED, AN ANGIOGRAPH REPORTEDLY REVEALED THE PROXIMAL CTAG-AC MOVED DISTALLY ABOUT 2CM UPON DEPLOYMENT. THE CAUSE OF THE ALLEGED DEVICE MOVEMENT IS UNKNOWN, AND NO ISSUES WERE REPORTED WITH HANDLING AND OPERATING THE DEVICE PER THE INSTRUCTIONS FOR USE. ACCORDING TO THE REPORT, THE PROXIMAL CTAG-AC WAS POSITIONED AT NEARLY SAME LEVEL AS THE PROXIMAL END OF THE EXISTING GORE® TAG® THORACIC ENDOPROSTHESIS. NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE

  Patient problems: Aneurysm expansion

  MAUDE report 15265719 ↗

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