GORE TAG Conformable Thoracic Stent Graft TGMR313110Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00733132646777), received between Mar 17, 2020 and Sep 29, 2026 — classified as 3 deaths, 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940838 ↗
• DeathSep 4, 2026Malposition of Device; Migration

  It was reported that the patient underwent a Frozen Elephant Trunk (FET) procedure on (b)(6) 2026, for treatment of a Type A aortic dissection utilizing a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG).On August 10, 2026, the Field Sales Associate (FSA) was notified that the patient expired on (b)(6) 2026.Following the procedure, the physician reported concern that the device may have been implanted in the false lumen or, alternatively, may have migrated through a fenestration from the true lumen into the false lumen. The physician stated that the device appeared to be in the false lumen and that mesenteric malperfusion was present. An angiogram reportedly demonstrated no perfusion to the mesenteric vessels. The patient also experienced elevated potassium levels.The physician indicated that it was unclear whether the event represented initial device malposition or distal migration from the true lumen into the false lumen. Any migration distance was unknown. No deployment difficulties were reported. No completion angiogram was performed, and no imaging was available for review. The physician did not specifically attribute the patient's death to the CTA

  Patient problems: Insufficient Information

  MAUDE report 50621371 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported from the iMedidata study database:On (b)(6) 2026, a patient was treated for a thoracoabdominal aneurysm following open repair of a dissection using a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System.On the same day, after the procedure, a stroke was noted. Imaging demonstrated a clinical infarct. No Treatment was given, and the patient recovered (b)(6) 2026.

  Patient problems: Stroke/CVA

  MAUDE report 50501088 ↗
• MalfunctionMay 15, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION, UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GRAFT DID NOT DEPLOY WHEN THE FIRST STAGE HANDLE WAS RELEASED. AFTER THE SECONDARY STAGE WAS RELEASED, THE GRAFT FINALLY DEPLOYED. WHEN THE GRAFT WAS DEPLOYED THE STRINGS ATTACHED TO THE MECHANISM POPPED, CAUSING THE DEPLOYMENT TO HAPPEN TOP-DOWN, INSTEAD OF THREE SEQUENTIAL STEPS. THE PHYSICIAN WAS ABLE TO REPOSITION THE GRAFT, AND THE PHYSICIAN WAS SATISFIED WITH FINAL POSITION. NO HARM TO THE PATIENT WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028012 ↗
• DeathMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WITH A GORE® TRI-LOBE BALLOON CATHETER TO TREAT A THORACIC DISSECTION WITH AN INTRAMURAL HEMATOMA PRESENT. IT WAS REPORTED THAT AFTER DEPLOYING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313110/(B)(6)), IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN CHOSE TO USE A GORE® TRI-LOBE BALLOON CATHETER TO BALLOON THE ENDOLEAK. REPORTEDLY THE PHYSICIAN WAS ¿AGGRESSIVELY¿ BALLOONING THE PROXIMAL ENDOLEAK AND PERFORATED THE AORTA. WHILE RETRACTING THE BALLOON THE PATIENT CODED. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313110/(B)(6)) TO TREAT THE PERFORATED AORTA. A BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT NEVER RECOVERED FROM THE CODE AND EXPIRED IN THE OPERATING ROOM. REPORTEDLY THE PATIENT HAD A FRIABLE AORTA WITH HISTORY OF CARDIAC ISSUES AND PERIPHERAL VASCULAR DISEASE. DURING THE CODE THE PATIENT DEVELOPED A PLEURAL EFFUSION FROM THE BLEEDING.

  Patient problems: Vascular Dissection

  MAUDE report 21703394 ↗
• DeathNov 18, 2024Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT PRESENTED WITH A TRAUMATIC TEAR AND SEVERE AORTIC INTRAMURAL HEMATOMA (IMH) IN PROXIMAL THORACIC AORTA WITH POSSIBLE DISSECTION AS WELL. PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE FOR THE TRAUMA ACCIDENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). THE PLAN FOR THE PROCEDURE WAS TO PUT A STENT GRAFT FROM THE LEFT SUBCLAVIAN ARTERY (LSA), ABOUT 10CM DISTALLY ACROSS FROM THE TRAUMATIC TEAR WITH THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). CASE PROCEEDED AS PER NORMAL WITH DEVICE IN PLACE BUT THE PIGTAIL WOULDN'T ADVANCE AROUND THE ARCH. THE CTAGAC MAY NOT HAVE BEEN SUPPORTED FULLY ON THE STIFF PART OF THE LUNDERQUIST WIRE AS THE WIRE HAD COME BACK IN THE GRAFT. PHYSICIAN WAS TRYING TO ADVANCE THE PIGTAIL TO GET THE FLURO IMAGING WHEN THE PATIENT CODED. PHYSICIAN DID A HAND INJECTION THROUGH THE PIGTAIL AND IT APPEARS THE CTAGAC HAD PERFORATED THROUGH THE AORTIC WALL, DISTAL TO THE LSA. DEVICE WAS REMOVED AND CODA BALLOON WAS ADVANCED INTO PLACE TO CONTROL THE BLEEDING. PHYSICIAN THEN TRIED TO GET ACCESS

  Patient problems: Perforation

  MAUDE report 20705093 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 3 OF LEFT SUBCLAVIAN ARTERY TO TREAT A DISSECTION AND AORTIC INTRAMURAL HEMATOMA (IMH) UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS IN STABLE CONDITION, HOWEVER, THE BLOOD PRESSURE WAS EXTREMELY HIGH, OVER 200 (MMHG). AT THE TIME, MEDICAL TEAM WAS UNSURE IF IT WAS A RUPTURE OR FLUID IN THE LEFT CHEST. PHYSICIAN DID NOT THINK ITS RUPTURE AND PHYSICIAN DID NOT HAVE THE OFFICIAL READINGS FROM THE RADIOLOGISTS AS THE CT SCAN WAS DONE AT A SMALLER HOSPITAL BEFORE PATIENT WAS SHIFTED. ON (B)(6) 2024, THE PATIENT BECAME UNSTABLE AS THERE WAS FLUID IN THE LEFT CHEST. PHYSICIAN DID A REINTERVENTION WITH DISTAL EXTENSION FROM THE ORIGINAL GRAFT WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (34MM X 20CM) AND LANDED JUST ABOVE THE CELIAC ARTERY. THE PROCEDURE WENT WELL AND PATIENT IS STABLE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 20598830 ↗
• MalfunctionSep 8, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AS PART OF AN ELEPHANT TRUNK PROCEDURE. WHEN THE DEVICE WAS DEPLOYED, THE PHYSICIAN SAID THAT IT LOOKED "CRINKLED" ON ONE SIDE. THE LENGTH OF THE DEVICE WAS PULLED TOGETHER ON ONE SIDE. THEY DECIDED TO REMOVE THE DEVICE AND IMPLANT A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN ITS PLACE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT, AND THE PATIENT TOLERATED THE PROCEDURE. THE FSA BELIEVES THE ISSUE WAS CAUSED BY NOT MAKING SURE THE DELIVERY SYSTEM WAS STRAIGHT BEFORE DEPLOYING THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711845 ↗
• InjuryJun 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, THIS PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT EXPLANT OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE REASON FOR EXPLANT OF THE DEVICE IS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17243462 ↗
• MalfunctionMay 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES REPRESENTATIVE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. PRIOR TO IMPLANT PROCEDURE, THE PATIENT¿S CHEST WAS OPENED, AND BEING TREATED FOR AN OFF-LABEL PROCEDURE (TYPE A DISSECTION IN DESCENDING AORTA). REPORTEDLY THE DAY OF THE PROCEDURE THE PATIENT TESTED POSITIVE FOR PCP, COCAINE, AND MARIJUANA. IT WAS REPORTED THAT THE PHYSICIAN WAS DEPLOYING THE DEVICE ANTEGRADE AND HOLDING THE DELIVERY CATHETER WHILE THE SURGICAL TECH WAS DEPLOYING THE DEVICE. WHEN PULLING THE RED KNOB, THE SURGICAL TECH WAS TURNING AND PULLING TOO AGGRESSIVELY AND BROKE THE RED KNOB OFF THE DELIVERY CATHETER. THE PHYSICIAN ATTEMPTED TO USE BACK UP HATCH ACCESS FOR DEPLOYMENT, BUT ¿THE WIRES WOULD NOT RELEASE AND WERE UNABLE TO BE PULLED¿. THE DELIVERY CATHETER WITH UNDEPLOYED DEVICE WAS REMOVED FROM PATIENT. A NEW DEVICE WAS USED AND DEPLOYED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 16946932 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR TREATMENT OF A TYPE B SUBACUTE COMPLICATED DISSECTION AND WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. AS REPORTED, THERE WAS NO CONCERN WITH APPOSITION OF THE INITIALLY IMPLANTED DEVICE. AS REPORTED, ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT FOLLOW UP EXAMINATION AND THERE WERE NO IDENTIFIED CONCERNS. AS REPORTED, ON (B)(6) 2022, APPROXIMATELY THREE WEEKS AFTER THE FOLLOW UP VISIT, THE PATIENT PRESENTED WITH CHEST PAIN. AS REPORTED, A TYPE A RETROGRADE DISSECTION WAS IDENTIFIED. AS REPORTED, THE DISSECTION EXTENDED FROM THE TOP OF THE ENDOGRAFT ALL THE WAY DOWN TO ABOVE THE AORTIC VALVE. AS REPORTED, A REINTERVENTION WAS PERFORMED IN WHICH OPEN SURGICAL ASCENDING REPAIR WAS USED TO TREAT THE DISSECTION. AS REPORTED, ONGOING MONITORING OF THE PATIENT WILL OCCUR. AS REPORTED, IT IS NOT CLEAR WHAT THE CAUSE OF THE DISSECTION WAS. AS REPORTED BY THE PHYSICIAN, THE TEAR WAS AT THE LESSER CURVE OF THE AORTA RIGHT WHERE THE BARE APICES OF THE STENT ARE LOCATED.

  Patient problems: Vascular Dissection

  MAUDE report 15198499 ↗
• MalfunctionApr 22, 2022Failure to Disconnect; Failure to Disconnect

  AS REPORTED, ON (B)(6) 2022 THE PATIENT WAS ADMITTED FOR TREATMENT OF AN EMERGENCY TYPE A DISSECTION. IT WAS NOTED THAT THE THERE WAS ALSO A TYPE B DISSECTION PRESENT AND THE PHYSICIAN DECIDED TO TREAT THIS AS WELL ONCE THE PATIENT BECAME SYMPTOMATIC. A FROZEN ELEPHANT TRUNK PROCEDURE WAS CONDUCTED USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR313110) WAS CHOSEN. DEPLOYMENT WAS SUCCESSFUL FOR THE FIRST TWO STAGES OF DEPLOYMENT WITH THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. WHEN THE PHYSICIAN WAS PROCEEDING WITH RELEASE OF THE DEVICE FROM THE CATHETER A LARGE POP WAS HEARD AND IT WAS OBSERVED THAT THERE WAS NO LOCKWIRE CONNECTED TO THE HANDLE. AS REPORTED, THE BACKUP DEPLOYMENT ACCESS HATCH WAS OPENED AND THE LOCKWIRE WAS NOT OBSERVED. GIVEN THE WAY THE DEVICE WAS DEPLOYED, THE PHYSICIAN WAS ABLE TO PULL THE GRAFT AND DELIVERY SYSTEM OUT AND PLACED ANOTHER IN ITS PLACE. THE SECOND ENDOPROSTHESIS AND DEPLOYED NORMALLY. AS REPORTED, THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189926 ↗
• MalfunctionFeb 14, 2022Separation Problem; Separation Problem

  ON (B)(6) 2022 THE PATIENT WAS UNDERGOING A FROZEN ELEPHANT TRUNK PROCEDURE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AS REPORTED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE BUT THE NOSE CONE WOULD NOT BECOME DETACHED FROM THE GRAFT. THE PHYSICIAN WAS THEREFORE UNABLE TO USE THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE EVENT BUT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13528302 ↗
• MalfunctionFeb 8, 2022Device Handling Problem; Device Handling Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT TREATMENT FOR A TYPE A DISSECTION AND HEMIARCH USING A FROZEN ELEPHANT TRUNK PROCEDURE AND A GORE® TAG®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

  Patient problems: Vascular Dissection

  MAUDE report 13481161 ↗
• InjuryNov 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT SURGERY FOR AN ANEURYSM REPAIR USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2021 DURING A FOLLOW UP APPOINTMENT A CT SCAN WAS PERFORMED AND AN INFECTION WAS FOUND WITHIN THE DEVICE. AT THIS TIME IT IS UNDETERMINED IF THE PATIENT HAD A PRIOR INFECTION OR IF IT IS DUE TO THE GRAFT. THE GRAFT WILL BE EXPLANTED, BUT AT THIS TIME THE DATE AND LOCATION IS UNKNOWN. INVESTIGATION IS ONGOING.

  Patient problems: Unspecified Infection

  MAUDE report 12845032 ↗
• MalfunctionMar 2, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FSA REPORTED: ON (B)(6) 2021, THIS PATIENT UNDERWENT OPEN AORTIC ARCH REPAIR AND TREATMENT FOR A DESCENDING THORACIC AORTIC DISSECTION. A FROZEN ELEPHANT PROCEDURE WAS PERFORMED FIRST FOR THE DESCENDING THORACIC AORTA REPLACEMENT. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED DISTALLY FOR ANTEGRADE DEPLOYMENT AND FULLY DEPLOYED TO ITS FULL DIAMETER. ALL FOUR HANDLES WERE PULLED OUT AND DEPLOYED WITHOUT ISSUE HOWEVER THE DEVICE STAYED CONNECTED TO THE DELIVERY CATHETER INSIDE THE SLEEVE. THE PHYSICIAN CUT THE DELIVERY SYSTEM OUT AND THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402082 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT TREATMENT FOR AORTIC DISSECTION BY IMPLANTING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG WITH ACTIVE CONTROL). THE PATIENT TOLERATED THE PROCEDURE. ON FOLLOW UP IMAGES (COMPUTED TOMOGRAPHY DATED (B)(6) 2021, REVEALED THE DISSECTION HAD PROGRESSED DISTAL TO IMPLANTED DEVICE. ON (B)(6) 2021, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DISTAL TO PREVIOUSLY IMPLANTED DEVICE. THE DISSECTION WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 11386221 ↗
• MalfunctionAug 10, 2020Activation Failure; Material Split, Cut or Torn; Activation Failure; Material Split, Cut or Torn

  ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN STENT GRAFTING USING ENDOVASCULAR TREATMENT OF THE THORACIC AORTA VIA A MEDIAN STERNOTOMY WITH ANTEGRADE RELEASE OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (FROZEN ELEPHANT TRUNK TECHNIQUE). NO INTRODUCER SHEATH WAS USED DUE TO THE NATURE OF THE OPEN PROCEDURE AND ANTEGRADE DEPLOYMENT. THE DEVICE REPORTEDLY DEPLOYED TO 50% DURING PRIMARY DEPLOYMENT. RESISTANCE WAS NOTED DURING DEPLOYMENT, AND ULTIMATELY THE DEPLOYMENT LINE BROKE WHILE THE DEVICE WAS AT 50% DEPLOYMENT. THE CAUSE OF DEPLOYMENT LINE BREAK WAS UNKNOWN, BUT IT WAS REPORTED THAT IT WAS SUSPECTED TO BE RELATED TO THERE BEING A LOOP IN THE LENGTH OF THE CATHETER. REPORTEDLY THE CATHETER WAS LOOPED AND UNABLE TO BE HELD STRAIGHT DUE TO THE NATURE OF THE ANTEGRADE DEPLOYMENT. IT WAS REPORTED THAT THE DEVICE WAS NOT TORQUED OR ROTATED SIGNIFICANTLY IN EITHER DIRECTION DURING INTRODUCTION OR ADVANCEMENT. NO SIGNIFICANT TORTUOSITY, THROMBUS, OR CALCIFICATION WAS NOTED THAT WAS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT. THE DEVICE WAS SUCCESSFULLY REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388913 ↗
• MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE ONE THORACIC AORTIC ARCH DISSECTION WITH A FROZEN ELEPHANT TRUNK AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. A TGMR313110/(B)(4) WAS ADVANCED WITHIN THE DESCENDING THORACIC AORTA PRIMARY DEPLOYMENT OF THE DEVICE TO IT¿S INTERMEDIATE DIAMETER (50%) WAS PERFORMED. THE PHYSICIAN THEN PROCEEDED TO EXECUTE THE SECONDARY DEPLOYMENT HOWEVER WHEN HE PULLED BACK THE SECONDARY DEPLOYMENT HANDLE THERE WAS NO SECONDARY DEPLOYMENT LINE ATTACHED AND THE GRAFT ONLY DEPLOYED ABOUT 1CM, NOT FULLY DEPLOYING. THE PHYSICIAN TRIED MANIPULATING THE DEVICE TO GET IT TO FULLY DEPLOY BUT IT WOULD NOT. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10371069 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM ON (B)(6) 2020 USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2020, FOLLOW UP REVEALED A TYPE IA ENDOLEAK. A REINTERVENTION IS PLANNED BUT CURRENTLY NOT SCHEDULED. IT WAS REPORTED THAT THE DEVICE NEEDS TO BE EXTENDED PROXIMALLY. IMAGES WERE RETURNED FOR EVALUATION. THE IMAGING EVALUATION STATED:THERE ARE 2-TIME POINTS AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2019 AND POST-IMPLANTATION CTA DATED (B)(6) 2020. PRE-IMPLANTATION IMAGING APPEARS TO SHOW A PAU IN THE PROXIMAL DTA. POST-IMPLANTATION CTA APPEARS TO SHOW: THERE APPEARS TO BE CONTRAST OUTSIDE THE PROXIMAL IMPLANTED DEVICE. THERE APPEARS TO BE CONTRAST OUTSIDE THE DEVICE POSTERIORLY, ALSO. CONTRAST OUTSIDE THE POSTERIOR DEVICE APPEARS TO COMMUNICATE WITH AN INTERCOSTAL ARTERY. CANNOT CONFIRM ANTE GRADE OR RETROGRADE FLOW IN THE INTERCOSTAL ARTERY. PROBABLE TYPE IA ENDOLEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9842543 ↗

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