GORE TAG Conformable Thoracic Endoprosthesis TGU343420Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132618170), received between Jun 23, 2018 and Nov 19, 2021 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2021Adverse 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) 2017 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 0 IN THE SSB 11-02 STUDY. A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS WAS UTILIZED IN THE PROCEDURE. ON (B)(6) 2021 AN ENDOLEAK, PROXIMAL (REPORTEDLY PROBABLE TYPE II) SEGMENTAL THORACIC VESSEL, WITH INTERVAL INCREASE IN THE SIZE OF THE AORTIC SAC OCCURRED. THIS INCREASE WAS AT THE LEVEL OF THE CARINA THE AORTIC SAC HAS INCREASED FROM 6.6 X 6.7 CM TO 7.3 X 7.3 CM AT THE LEVEL OF THE INFERIOR LEFT PULMONARY VEIN THE AORTIC SAC PREVIOUSLY 6.5 X 7 CM NOW MEASURES 7 X 7.6 CM. ON (B)(6) 2021 A REINTERVENTION TOOK PLACE TO TREAT THE ENDOLEAK AND THE PATIENT DID WELL FOLLOWING THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12849282 ↗
• InjurySep 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) 2016 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN DESCENDING THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2016 SHOWED THE ANEURYSM MEASURED 55.0 MM. FOLLOW UP CTA EXAMINATION ON (B)(6) 2016 SHOWED THE ANEURYSM MEASURED 49.0 MM. FOLLOW UP CTA EXAMINATION ON (B)(6) 2016 SHOWED THE ANEURYSM MEASURED 49.9 MM. FOLLOW UP CTA EXAMINATION ON (B)(6) 2019 SHOWED THE ANEURYSM MEASURED 66.0 MM. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR TRANSIENT LOSS OF CONSCIOUSNESS.

  Patient problems: Aneurysm; Loss of consciousness

  MAUDE report 12460210 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK WITH NO ENLARGEMENT OF THE ANEURYSM. THE PATIENT UNDERWENT A RE-INTERVENTION ON THE SAME DAY AND AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS PLACED PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE ENDOLEAK WAS CAUSED BY DISEASE PROGRESSION.

  Patient problems: Aneurysm

  MAUDE report 10171853 ↗
• MalfunctionJun 3, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS(CTAG) WAS IMPLANTED FOR TREATMENT OF INTRAMURAL HEMORRHAGE AND HEMATOMA. DUE TO THE LONG LESION, IT WAS PLANNED TO PLACE A STENT (XIANJIAN) AT THE DISTAL END, THEN CTAG DEVICE WAS PLACED AT THE PROXIMAL END, AND THE OVERLAP BETWEEN THE TWO DEVICES WAS ABOUT 4 CM. PREPARING FOR THE OPERATION, A COOK 16F SHEATH WAS INSERTED TO PRE-DILATE, AND A PIGTAIL CATHETER WAS INSERTED FROM THE LEFT FEMORAL ARTERY FOR PRECISE POSITIONING OF THE CTAG DEVICE. AFTER THE PHYSICIAN WITHDREW THE DELIVERY SYSTEM OF FIRST STENT(XIANJIAN), CTAG DEVICE WAS ADVANCED THROUGH 22F SHEATH FROM RIGHT FEMMRAL ARTERY TO TARGET LESION AND THE WHOLE DEPLOYMENT LINE WAS PULLED OUT. THE PHYSICIAN FOUND THE MIDDLE(5-6CM) OF CTAG DEVICE WAS IN A SEMI-RELEASED STATE AND THE DEVICE DIDN'T EXPAND TO ITS FULL DIAMETER. THE REST OF THE CTAG DEVICE WAS SUCCESSFULLY EXPANDED. THEN A GORE TRI-LOBE BALLOON CATHETER WAS USED TO DILATE THE PROXIMAL AND MIDDLE OF THE DEVICE. IT IMPROVED AND THE PROCEDURE WAS COMPLETED. ON THE NEXT DAY, CT EXAMINATION REVEALED OBVIOUSLY FOLDING IN THE MIDDLE OF CTAG. THE PATIENT IS DOING WELL AND MO

  Patient problems: Not Applicable

  MAUDE report 10117333 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A DESCENDING THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2020, REVEALED EITHER A RETROGRADE FLOW/ENDOLEAK OR CONTINUATION OF THE DISSECTION. THE CAUSE IS UNKNOWN, THERE IS NO PLANNED REINTERVENTION, REPORTEDLY THE PATIENT HAS REFUSED ANY FUTURE REINTERVENTION. THE EVENT IS ONGOING.

  Patient problems: Aortic Dissection

  MAUDE report 10026710 ↗
• InjuryDec 6, 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) 2019 A PATIENT UNDERWENT TREATMENT OF A DEBAKEY TYPE II AORTIC DISSECTION WITH 2 GORE® ASCENDING STENT GRAFTS 1 AORTIC COMPONENT FROM THE GORE TAG® THORACIC BRANCH ENODPROSTHESIS SYSTEM, 1 SIDE BRANCH COMPONENT FROM THE GORE TAG® THORACIC BRANCH ENODPROSTHESIS SYSTEM AND 1 CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE LARGEST RECORDED AORTIC MEASUREMENT RECORDED WAS 55MM, AT THE PRIMARY ENTRY TEAR. ON (B)(6) 2019 A TYPE II ENDOLEAK WAS DISCOVERED BY CT. THE MAXIMUM AORTIC MEASUREMENT IS NOT INDICATED IN THE REPORT. ON (B)(6) 2019 AN ATTEMPT TO REINTERVENE ON THE TYPE II ENDOLEAK WAS MADE. HOWEVER THE PROCEDURE WAS DISCONTINUED AFTER A SNARE WIRE, INTRODUCED THROUGH A NON-GORE SNARE CATHETER SHEATH CAUSED A PUNCTURE IN THE RIGHT COMMON ILIAC ARTERY. THIS WAS REPAIRED AND A DECISION WAS MADE TO RESCHEDULE THE TREATMENT FOR THE TYPE II ENDOLEAK. INCIDENTALLY, A RIGHT BRACHIAL HEMATOMA WAS FOUND ON THE SAME DAY AND TREATED BY MEANS OF THROMBECTOMY, BUT NO GORE DEVICES WERE ASSOCIATED WITH THIS HEMATOMA. NO TRANSFUSION WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9434359 ↗
• InjuryJul 3, 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 WAS UNDERGOING TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION, ZONE 2 WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE WAS 44.6MM. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6), 2018 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 47MM. ON (B)(6), 2019 THE MAXIMUM AORTIC DIAMETER IN THE TREATED SEGMENT WAS 50.9MM ON (B)(6), 2019 DISTAL AORTIC FALSE LUMEN PERFUSION WAS NOTED. ON (B)(6), 2019 A REINTERVENTION TOOK PLACE WHEREBY THE DISTAL TREATMENT ZONE WAS EXTENDED WITH A ZENITH THORACIC ENDOVASCULAR GRAFT 38 X 1117MM (MODEL/CAT # G35357 / LOT # E3813611) MANUFACTURER: COOK-AORTIC. THE REINTERVENTION HAD A SUCCESSFUL OUTCOME.

  Patient problems: Aneurysm

  MAUDE report 8761500 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A TYPE B COMPLICATED AORTIC DISSECTION USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2019, THE PATIENT PRESENTED WITH WORSENING BASELINE HYPERTENSION, LEADING TO CONCERN FOR DEVELOPMENT OF MALPERFUSION OF THE VISCERAL SEGMENT (INCLUDING RENALS). THE PATIENT ALSO HAD ISSUES WITH LUMBAR DRAIN PLACEMENT, SO A DIAGNOSTIC ANGIOGRAM WAS COMPLETED (B)(6) 2019. ON (B)(6) 2019, THE PATIENT UNDERWENT A TEVAR GRAFT EXTENSION TO IMPROVE HEMODYNAMICS IN PERIVISCERAL AORTA. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8745201 ↗
• MalfunctionMar 4, 2019Improper or Incorrect Procedure or Method; Premature Separation; Improper or Incorrect Procedure or Method; Premature Separation

  IT WAS REPORTED TO GORE THAT ON (B)(4) 2019, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS TO BE IMPLANTED DURING TREATMENT OF A THORACIC AORTA DISSECTION. IT WAS REPORTED THE TAG DEVICE WAS INSERTED AND ADVANCED TO THE TARGET LESION, THE DEPLOYMENT LINE WAS BROKEN WHEN INITIATING THE DEPLOYMENT LINE. THE DEVICE WAS NOT DEPLOYED INSIDE THE PATIENT'S BODY, SO THE ENTIRE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT, AND ANOTHER CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS USED TO CONTINUE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Not Applicable

  MAUDE report 8388771 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2017, A REINTERVENTION WAS PERFORMED INVOLVING COVERAGE OF THE LEFT SUBCLAVIAN ARTERY ORIGIN, THE ORIGINAL ENDOPROSTHESES PLUS A DESCENDING THORACIC AORTIC EXTENSION TO THE LEVEL OF THE CELIAC ARTERY ORIGIN USING ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES DUE TO ENLARGING MULTIPLE DESCENDING THORACIC PENETRATING ATHEROSCLEROTIC ULCERS/SACCULAR ANEURYSMS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8156751 ↗
• 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 THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2017, THE PATIENT UNDERWENT TREATMENT OF A 32 CM (TOTAL TREATMENT LENGTH) DESCENDING THORACIC AORTIC (ZONE 2) DISSECTION, DISTAL TO THE LEFT COMMON CAROTID ARTERY OSTIUM AND PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343420/(B)(4)) AND TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC123420C/(B)(4) AND TSB121506C/(B)(4)). ACCORDING TO THE REPORT, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS THE INTENDED BRANCH VESSEL TO BE TREATED. REPORTEDLY, PRE-IMPLANTATION IMAGES TAKEN ON (B)(6) 2017, SHOWED A MAXIMUM AORTIC DIAMETER OF 66.2 MM WITHIN THE TREATMENT SEGMENT. AN ATHEROMA WAS NOTED PROTRUDING > 5MM INTO THE LUMEN. NO SIGNIFICANT CALCIUM AND/OR THROMBUS AT THE PROXIMAL OR DISTAL IMPLANTATION SITES WAS SEEN ON THE PRE-TREATMENT IMAGES. SUCCESSFUL ACCESS AND DELIVERY TO THE INTENDED IMPLANTATION SITES AND RETRIEVAL OF THE DEVICE DELIVERY SYSTEMS WAS REPORTED. FINAL ANGIOGRAPHY CONFIRMED REPAIR OF THE DISSECTION, FULL PATENCY OF ALL DEVICES AND NO EVIDENCE OF PERSISTENT FALSE LUMEN PERFUS

  Patient problems: Aneurysm; Aortic Dissection

  MAUDE report 8145122 ↗
• InjuryOct 28, 2018Adverse 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) 2016 A PATIENT UNDERWENT TREATMENT OF A TYPE B COMPLICATED AORTIC DISSECTION WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE MAXIMUM AORTIC DIAMETER MEASURED 46.4MM. ON (B)(6) 2018 THE PATIENT EXHIBITED LEFT LOWER LIMB CLAUDICATION AND UNDERWENT AN ADDITIONAL ENDOVASCULAR REPAIR OF THE THORACIC DISSECTION. ADDITIONALLY A LEFT COMMON ILIAC ARTERY EXTERNAL ILIAC ARTERY STENT ANGIOPLASTY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Claudication; Not Applicable; Vascular Dissection

  MAUDE report 8011730 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016, THIS PATIENT UNDERWENT A REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM WHEREBY TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED IN ZONE 4 OF THE THORACIC AORTA. TWO STENTS WERE ALSO REPORTEDLY IMPLANTED IN THE CELIAC AND SUPERIOR MESENTERIC ARTERIES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 66MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. FROM (B)(6) 2016 TILL (B)(6) 2016, THE FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 70MM. ON (B)(6) 2018, THE FOLLOW UP CTA DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 76MM. ADDITIONALLY, ON (B)(6) 2018, A PROXIMAL TYPE I ENDOLEAK ASSOCIATED WITH A TGU343420/14653201 WAS IDENTIFIED. ON (B)(6) 2018, THE REINTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED.

  Patient problems: Aneurysm

  MAUDE report 7981539 ↗
• InjuryJun 23, 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) 2017, THE PATIENT UNDERWENT TREATMENT OF A 32 CM (TOTAL TREATMENT LENGTH) DESCENDING THORACIC AORTIC (ZONE 2) DISSECTION, DISTAL TO THE LEFT COMMON CAROTID ARTERY OSTIUM AND PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343420/(B)(4)) AND TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC123420C/(B)(4) AND TSB121506C/(B)(4)). ACCORDING TO THE REPORT, THE LEFT SUBCLAVIAN ARTERY (LSA) WAS THE INTENDED BRANCH VESSEL TO BE TREATED. ON (B)(6) 2018 THE THORACOABDOMINAL ANEURYSM WAS REPORTEDLY ENLARGING, FROM CHRONIC ANEURYSMAL DEGENERATION OF A DEBAKEY TYPE I DISSECTION. ON (B)(6) 2018 AN ABDOMINAL AORTIC STENT GRAFT PLACEMENT WAS PERFORMED TO TREAT THE ENLARGING THORACOABDOMINAL ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 7632593 ↗

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-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