GORE TAG Conformable Thoracic Stent Graft TGM343410Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00733132646951), received between Aug 19, 2020 and Feb 4, 2026 — classified as 2 deaths, 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC SACCULAR AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL DEVICE. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PRE- TREATMENT IMAGING SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTA WAS 34.6MM. ON (B)(6) 2025, A SITE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE TREATED THORACIC AORTA WAS 51MM. NO ENDOLEAK WAS NOTICED. ON (B)(6) 2025, A GORE CORE LAB FOLLOW UP IMAGING NOTICED AN INDETERMINATE ENDOLEAK. THE GORE IMAGING COMMENTED THERE WAS AN APPEARANCE OF AN ENDOLEAK APPROXIMATELY MID TREATED LESION. UNABLE TO DETERMINE SOURCE. WHEN WAS LOOKING BACK AT PRE-PROCEDURE THERE APPEARS TO BE ABOUT 9MM OF SEAL ZONE BETWEEN THE DISTAL LSA AND THE PROXIMAL ASPECT OF THE LESION. THE EVENT IS ONGOING. NO TREATMENT WAS DONE TO FIX AN ENDOLEAK. THE PHYSICIAN IS MONITORING THE PATIENT. ACCORDING TO THE PHYSICIANS, THE GRAFT IS WELL SEATED WITH NO EVIDENCE OF ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24264387 ↗
• MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT A FROZEN ELEPHANT TRUNK PROCEDURE TO TREAT A DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, PHYSICIAN WENT TO DEPLOY THE GRAFT WITH THE FIRST DEPLOYMENT STEP AND THE HANDLE CAME BACK WITH NO DEPLOYMENT LINE ATTACHED. 1ST STAGE OF DEPLOYMENT FAILED TO DEPLOY. PHYSICIAN WAS UNSURE WHY THE DEVICE FAILED TO DEPLOY WITH GUIDEWIRE DOWN AND CATHETER STRAIGHT. THEY REPLACED THAT DEVICE WITH ANOTHER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO PATIENT AS RESULT OF THE FAILED DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015496 ↗
• InjuryMay 9, 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) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, ALL THREE DEVICES WERE IMPLANTED SUCCESSFULLY WITH NO DEPLOYMENT ISSUES AND FULLY COVERED THE DISSECTION AREA. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT HAD SUFFERED A RIGHT SIDED STROKE. THE INITIAL PROCEDURE HAD GONE AS PLANNED AND PHYSICIAN IS NOT SURE WHAT CAUSED THE STROKE AS THEY WERE NOT OPERATING IN THAT AREA WHICH LED TO THE STROKE. THE PATIENT IS CURRENTLY EXPERIENCING LEFT ARM WEAKNESS AND SLURRED SPEECH. ON (B)(6) 2025, IT WAS REPORTED THAT PATIENT IS GETTING BETTER AND CAUSE OF STROKE REMAINS UNKNOWN.

  Patient problems: Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 21997733 ↗
• InjuryFeb 10, 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) 2023, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THERE WAS A REINTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). AN ADDITIONAL DEVICE WAS IMPLANTED DISTALLY, THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE ROOT CAUSE OF THE ENDOLEAK IS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 21351397 ↗
• InjuryDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXPRESSIVE APHASIA. THE PATIENT RECEIVED AN MRI AND IT WAS CONFIRMED THAT THE PATIENT EXPERIENCED A STROKE. THERE ARE NO PLANS TO RE-INTERVENE ON THE PATIENT. THE PATIENT IS BEING MONITORED AS OF NOW. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE EVENT TO OCCUR.

  Patient problems: Ischemia Stroke

  MAUDE report 21037103 ↗
• InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT PRESENTED WITH AN ACUTE TYPE B AORTIC DISSECTION WITH MALPERFUSION OF THE LOWER EXTREMITIES AND SELECT VISCERAL VESSELS. THE PHYSICIAN PLANNED TO TREAT THE DISSECTION AND MALPERFUSION VIA A ZONE 2 TEVAR PROCEDURE USING A COOK DISSECTION STENT EXTENSION TO THE INFRARENAL AORTA. SIZING WAS ASSESSED ON PRE-OPERATIVE CTA AND, FOLLOWING ADDITIONAL IVUS ASSESSMENT, A TGM343415 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) WAS SELECTED FOR ZONE 2 TREATMENT. A 22FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY OVER A LUNDERQUIST DOUBLE CURE WIRE, WITH CONTRALATERAL ACCESS FOR A 5FR. MARKER PIGTAIL. ANGIOGRAPHY WAS PERFORMED AND ARCH VESSELS WERE REFERENCED. FOLLOWING THE FIRST STAGE OF DEPLOYMENT FOR THE CTAG A/C, THE DEVICE APEX OF THE PROXIMAL STENT MARGIN CAME BACK TO THE LEFT SUBCLAVIAN ARTERY (LSA) OSTIUM. FOLLOWING ANGULATION INPUT AT FIRST STAGE/50% IT WAS DETERMINED THAT A ZONE 2 POSITION COULD NOT BE REESTABLISHED AND SECOND STAGE/100% DEPLOYMENT WAS COMPLETED IN THE STANDARD FASHION. ANGIOGRAPHY WAS PERFORMED AND MINOR FILLING OF THE LSA AND PRIMARY ENTRY TEAR WAS OBSERVED. PROXIMA

  Patient problems: Vascular Dissection

  MAUDE report 19493569 ↗
• MalfunctionApr 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED AND DID NOT DEPLOY.

  Patient problems: Vascular Dissection

  MAUDE report 19198556 ↗
• MalfunctionJun 19, 2023Break; Break

  ON (B)(6) 2023, THIS PATIENT UNDERWENT EMERGENT TREATMENT OF A DESCENDING THORACIC AORTIC DISSECTION AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. POST DEPLOYMENT, FLUOROSCOPY SHOWED THAT THE LEADING OLIVE TIP HAD BECOME DETACHED FROM THE DELIVERY SYSTEM CATHETER AND REMAINED IN THE DESCENDING THORACIC AORTA. AN ADDITIONAL DEVICE WAS IMPLANTED WITH THE EXPANDED DEVICE TRAPPING THE OLIVE AGAINST THE AORTIC WALL. THE REASON FOR THE DETACHMENT OF THE OLIVE WAS UNKNOWN, THE PHYSICIAN REPORTED NO DIFFICULTIES WITH DELIVERY, ADVANCEMENT, OR ANATOMICAL ISSUES FOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE DELIVERY CATHETER WAS RETAINED BY THE SITE FOR ANALYSIS BY GORE. THE RESULTS UPON COMPLETION WILL BE PROVIDED VIA SUBMISSION OF A SUPPLEMENTAL MEDWATCH.

  Patient problems: Vascular Dissection

  MAUDE report 17154486 ↗
• MalfunctionApr 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: IT WAS REPORTED THAT THE PHYSICIAN HAD TROUBLE WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS DURING DEPLOYMENT WHILE DOING AN ELEPHANT TRUNK PROCEDURE IN ZONE 0 ASCENDING AORTA. THE FIRST DEVICE, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 25480131, WAS DEPLOYED WITHOUT A WIRE AND THE PHYSICIAN ¿WAS UNABLE TO REMOVE THE RED LOCKWIRE FROM THE CATHETER. AFTER ACCESSING THE DEPLOYMENT LINE ACCESS HATCH AND CUTTING THE LOCKWIRE IN CHANNEL 3. HE WAS STILL UNABLE TO PULL THE WIRE AND REMOVE IT FROM THE CATHETER¿. AT THAT TIME, THE FSA SUGGESTED THE PHYSICIAN TO REMOVE THE ENTIRE DEVICE AND TRY ANOTHER GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 26157550, DURING DEPLOYING IT OVER AN AMPLATZ WIRE. THERE WAS NO ISSUE WITH THE FIRST TWO STEPS OF DEPLOYMENT, WHEN THE PHYSICIAN WENT TO RELEASE THE RED LOCKWIRE FROM THE CATHETER, IT ONCE AGAIN WOULD NOT RELEASE. HE ACCESSED THE HATCH AND CUT THE WIRE IN CHANNEL 3. HOWEVER, COULD STILL NOT REMOVE THE WIRE. AT THIS POINT, THE FSA SUGGESTED CUTTING THE CATHETER DISTAL TO THE OLIVE TIP TO RELEASE THE GRAFT. THE PHYSICIAN D

  Patient problems: Vascular Dissection

  MAUDE report 16727976 ↗
• MalfunctionApr 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: IT WAS REPORTED THAT THE PHYSICIAN HAD TROUBLE WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS DURING DEPLOYMENT WHILE DOING AN ELEPHANT TRUNK PROCEDURE IN ZONE 0 ASCENDING AORTA. THE FIRST DEVICE, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 25480131, WAS DEPLOYED WITHOUT A WIRE AND THE PHYSICIAN ¿WAS UNABLE TO REMOVE THE RED LOCKWIRE FROM THE CATHETER. AFTER ACCESSING THE DEPLOYMENT LINE ACCESS HATCH AND CUTTING THE LOCKWIRE IN CHANNEL 3, HE WAS STILL UNABLE TO PULL THE WIRE AND REMOVE IT FROM THE CATHETER¿. AT THAT TIME, THE FSA SUGGESTED THE PHYSICIAN TO REMOVE THE ENTIRE DEVICE AND TRY ANOTHER GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. THE SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT LOT 26157550, DURING DEPLOYING IT OVER AN AMPLATZ WIRE. THERE WAS NO ISSUE WITH THE FIRST TWO STEPS OF DEPLOYMENT, WHEN THE PHYSICIAN WENT TO RELEASE THE RED LOCKWIRE FROM THE CATHETER, IT ONCE AGAIN WOULD NOT RELEASE. HE ACCESSED THE HATCH AND CUT THE WIRE IN CHANNEL 3, HOWEVER COULD STILL NOT REMOVE THE WIRE. AT THIS POINT, THE FSA SUGGESTED CUTTING THE CATHETER DISTAL TO THE OLIVE TIP TO RELEASE THE GRAFT. THE PHYSICIAN DI

  Patient problems: Vascular Dissection

  MAUDE report 16727871 ↗
• DeathFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, AS A TREATMENT FOR A DESCENDING AORTIC RUPTURE, LEFT THORACIC CAVITY DRAINAGE WAS PERFORMED. FLUID/BLOOD/OXYGEN THERAPY AND SUCTION OF BLOODY SPUTUM WERE ALSO PERFORMED FOR THE TREATMENT OF THE DESCENDING AORTIC RUPTURE.

  Patient problems: Perforation of Vessels

  MAUDE report 16452110 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT PRESENTED EMERGENTLY AND UNDERWENT AN OFFLABEL ¿SNORKEL, SANDWICH¿ PROCEDURE FOR TREATMENT OF A CONTAINED RUPTURE OF A ZONE 3 LEFT SUBCLAVIAN ARTERY THORACOABDOMINAL ANEURYSM. MULTIPLE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED ALONG WITH MULTIPLE GORE® VIABAHN EXPANDABLE ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON FEBRUARY 2, 2023, THE PHYSICIAN REPORTED TO GORE THAT ON (B)(6) 2023, THE PATIENT HAD A DELAYED REACTION FOR SPINAL CHORD ISCHEMIA AND BECAME PARALYZED. THE GORE FIELD SALES ASSOCIATE (FSA) SUPPORTING THE CASE CONVEYED THAT THE PATIENT PRESENTED IN THE MIDDLE OF THE NIGHT AND IT WAS NOTED HE WAS ON PLAVIX AND THAT WAS WHY NO SPINAL DRAIN HAD BEEN PLACED PRIOR TO THE PROCEDURE. AS OF THE DATE OF REPORTING THE PATIENT REMAINS PARALYZED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16383361 ↗
• InjuryJan 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 0 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST PROCEDURE. THE PHYSICIAN ALSO NOTED THAT IT MAY HAVE OCCURRED INTRA PROCEDURE. REPORTEDLY THE CAUSE OF THE STROKE IS UNKNOWN, BUT IT WAS SUSPECTED TO BE RELATED TO WIRE AND DEVICE MANIPULATION. DUE TO THE ANATOMICAL TORTUOSITY, THERE WAS ALSO DIFFICULTY REPORTED WHILE ATTEMPTING TO ALIGN THE PORTAL OF THE THORACIC BRANCH AORTIC COMPONENT TO THE OUTER CURVE IN AORTIC ZONE 0. IT WAS REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL POST PROCEDURE FOR STROKE COMPLICATIONS INCLUDING APHASIA. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT THE PATIENT'S APHASIA WAS SIGNIFICANTLY IMPROVED, AND THE PATIENT WAS WALKING WITH THE PHYSICAL THERAPIST. THE PATIENT WAS REPORTEDLY DISCHARGED TO HOME ON OR ABOUT (B)(6) 2022.

  Patient problems: Stroke/CVA

  MAUDE report 16221809 ↗
• MalfunctionMay 7, 2022Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  AS REPORTED, ON AN UNSPECIFIED DATE A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC, (B)(4)) FAILED TO DEPLOY DURING A FROZEN ELEPHANT TRUNK PROCEDURE. AS REPORTED THE STRINGS WERE CUT AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. THE DEVICE IS BEING RETURNED FOR INVESTIGATION. ADDITIONAL DETAILS WERE REQUESTED AT THE TIME OF THE REPORT BUT REMAIN UNKNOWN. PATIENT INFORMATION WAS REQUESTED BUT WAS NOT MADE AVAILABLE BY THE TREATING FACILITY. A GORE REPRESENTATIVE WAS NOT ONSITE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316049 ↗
• InjuryOct 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE SSB11-02 PIVOTAL CLINICAL STUDY. ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2021, IT WAS REPORTED TYPE B AORTIC DISSECTION. REPORTEDLY RELATED TO DEVICE AND ENDOVASCULAR PROCEDURE. ON (B)(6) 2021, IT WAS RESOLVED WITHOUT SEQUELAE. TREATMENT DETAILS WERE NOT REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 12725627 ↗
• DeathOct 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION REPORTED: ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT IS UNKNOWN WHAT THE PATIENT WAS BEING TREATED FOR. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT EXPIRED. IT IS UNKNOWN WHAT THE CAUSE OF DEATH IS.

  Patient problems: Insufficient Information

  MAUDE report 12722303 ↗
• InjuryMar 12, 2021Malposition of Device; Malposition of Device

  ON (B)(6), 2011, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT TO TREAT A PENETRATING AORTIC ULCER. DURING THE PROCEDURE, THE PHYSICIAN HAD REPORTEDLY PLANNED TO LAND THE PROXIMAL END OF THE DEVICE AT THE MID-OSTIUM OF THE LEFT SUBCLAVIAN ARTERY (LSA) DUE TO A SHORT LANDING ZONE. UPON DEPLOYMENT, IT WAS NOTED THE DEVICE HAD UNINTENTIONALLY COVERED THE LSA. THE CAUSE OF THE UNINTENDED PLACEMENT IS UNKNOWN. A STENT WAS IMPLANTED IN THE LSA TO PRESERVE BLOOD FLOW, AND THE CASE WENT FORWARD TO COMPLETION WITHOUT ANY FURTHER REPORTED COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11473133 ↗
• InjuryAug 19, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER (PAU) USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL (CTAG/AC). THE PAU WAS DIFFICULT TO SEE UNDER ANGIOGRAPHY, BUT IT WAS IDENTIFIED AS BEING APPROXIMATELY 4CM DISTAL TO THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY (LSA). THE DEVICE WAS ADVANCED AND PLACED JUST DISTAL TO THE LSA AND DEPLOYED. THE PROCEDURE WAS CONCLUDED. AS THE PATIENT WAS BEING WHEELED INTO RECOVERY, HE NOTED HIS LEFT ARM WAS GETTING NUMB. HE WAS IMMEDIATELY BROUGHT BACK TO THE OPERATING ROOM WHERE IMAGING SHOWED THAT THE GRAFT MATERIAL OF THE CTAG/ AC WAS COVERING THE LSA. THEREFORE, A GORE® VIABAHN® VBX ENDOPROSTHESIS WAS USED AS A CHIMNEY TO RESTORE PERFUSION TO THE LSA. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME ON (B)(6) 2020.

  Patient problems: Paresis

  MAUDE report 10426850 ↗

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-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · 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