GORE TAG Conformable Thoracic Stent Graft TGM343420Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00733132646975), received between Jul 31, 2020 and Jun 10, 2026 — classified as 3 deaths, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT A THORACOABDOMINAL ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM FROM TYPE B DISSECTION (FALSE LUMEN DILATATION) UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6), 2025, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6), 2025, UNSCHEDULED FOLLOW-UP VISIT, IT WAS NOTED THAT THERE WAS A TYPE 1B ENDOLEAK WITH PARTIAL THROMBOSIS AND TYPE R OR RETROGRADE FLOW PERFUSED IN THE FALSE LUMEN ADJACENT TO THE THORACIC STENT GRAFT BUT IT WAS PATENT. PATIENT WAS CONTINUED TO BE MONITORED. ON (B)(6), 2026, UNSCHEDULED FOLLOW-UP VISIT, THORACIC STENT GRAFT REMAINED PATENT WITH NO SIGN OF TYPE 1B ENDOLEAK, HOWEVER, IT WAS REPORTED THAT THERE WAS A TYPE III ENDOLEAK BETWEEN THE TWO THORACIC STENT GRAFTS WITH NO DEVICE MIGRATION WITH MILD INCREASED ANEURYSM SAC (SIZE UNKNOWN) REQUIRING REINTERVENTION. ON (B)(6), 2026, PATIENT UNDERWENT REINTERVENTION PROCEDURE WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO REALIGN BOTH STENT GRAFTS AND RESOLVE THE TYPE III ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25462296 ↗
• DeathJun 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE SUBJECT WAS BEING TREATED FOR AN UNKNOWN ETIOLOGY, UTILIZING THE INVESTIGATIONAL GORE® ASCENDING STENT GRAFT (ASG CLINICAL STUDY 2402). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL WAS ALSO IMPLANTED DURING THE PROCEDURE. AS PER CLINICAL STUDY DATABASE, IT WAS REPORTED ON THE SAME DAY OF THE PROCEDURE (B)(6) 2026, THE SUBJECT EXPERIENCED AN ACUTE KIDNEY INJURY, TREATMENT INCLUDING RELIEVING MALPERFUSION SURGICALLY. IN ADDITION, SUBJECT ALSO EXPERIENCED A HEMORRHAGE EPISODE ON (B)(6) 2026, WHICH LED TO DEATH. IT IS CURRENTLY UNKNOWN IF THIS DEATH IS RELATED TO ANY POST-MARKET DEVICES. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Renal Impairment

  MAUDE report 25462009 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE NEXT DAY, THE PATIENT LOST BILATERAL LOWER EXTREMITY MOTOR FUNCTION. A SPINAL DRAIN WAS PLACED PRE-OPERATIVELY AS A PRECAUTION, AND WAS FUNCTIONING CORRECTLY. IT WAS ALSO REPORTED THERE WERE NO ISSUES OBSERVED DURING THE PROCEDURE WITH ANY OF THE GORE DEVICES. THE PHYSICIAN ATTRIBUTES THIS PARALYSIS DUE TO TOTAL COVERAGE OF THE THORACIC AND ABDOMINAL AORTA AT SAME STAGE, AND DOES NOT BELIEVE THE GORE DEVICES CAUSED THE PARALYSIS. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 24293155 ↗
• InjuryOct 15, 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, PATIENT PRESENTED TO EMERGENCY ROOM WITH CHEST DISCOMFORT AND PAIN. CTA SCAN SHOWED A TYPE B AORTIC DISSECTION WITH EXTENSION TO SUPERIOR MESENTERIC ARTERY, LEFT RENAL ARTERY WITH MARKED HYPOPERFUSION OF LEFT KIDNEY AND DISTAL AORTIC ANEURYSM (3.4CM SIZE). ON (B)(6) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR TO TREAT THE TYPE B AORTIC DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. PROCEDURE WENT WELL AND PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, PATIENT UNDERWENT AN MRI SCAN WHICH SHOWED EMBOLIC IN BRAIN AS PATIENT HAD A STROKE. ON (B)(6) 2025, FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED OF THE STROKE BY THE PHYSICIAN. IT COULD BE A PLAQUE FROM THE HEART OR ASCENDING AORTA BUT OVERALL CAUSE IS UNKNOWN ON THE STROKE. THERE ARE NO FURTHER UPDATES PROVIDED AFTER THIS DATE ON PATIENT STATUS BY THE PHYSICIAN, THUS, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 23295469 ↗
• InjuryJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024 THE FSA GOT CALLED IN FOR AN EMERGENT TYPE B AORTIC DISSECTION WITH MALPERFUSION OF AT LEAST ONE RENAL. THEY DEPLOYED THE DEVICES AS INTENDED WITHOUT ANY ISSUES. ON (B)(6) 2024 THE PHYSICIAN CALLED THE FSA AND REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN LAST NIGHT. HE GOT AN ADDITIONAL CTA SCAN, WHICH DID NOT SHOW ANYTHING THAT WAS GORE DEVICE RELATED. LATER IN THE NIGHT, THE PATIENT EXPERIENCED PARAPLEGIA, WHICH INCREASED HIS BLOOD PRESSURE. HE GOT A SPINAL DRAIN PLACED. THE PARAPLEGIA SYMPTOM IMPROVED HOWEVER, HE HAD MALPERFUSION SYMPTOMS AND HIS LACTATE WAS RAISING. THEY BROUGHT HIM BACK IN THIS MORNING AND PUT IN A NON-GORE CLIP DISSECTION STENT ACROSS THE VISCERAL AND A NON-GORE BARE METAL SELF-EXPANDING STENT (POSSIBLY A ZILVER) IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE ISSUE; HOWEVER, HE STATED THERE WAS NOT ANYTHING THAT SHOWED THAT THE GORE DEVICE WAS RELATED TO THE PATIENT SYMPTOMS. THE DEVICE REMAIN IMPLANTED.

  Patient problems: Pain; Paraplegia

  MAUDE report 21161561 ↗
• InjuryOct 27, 2023Adverse 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 ZONE 2 TYPE B THORACIC DISSECTION. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED WITH A DISTAL TYPE B DISSECTION. REPORTEDLY THE ¿STENT GRAFT INDUCED A NEW TEAR ENTRY JUST DISTAL TO THE IMPLANTED DEVICE¿. THERE IS A SCHEDULED REINTERVENTION PLANNED ON (B)(6) 2023. THE ADVERSE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 18025692 ↗
• InjuryAug 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION WITH AN ANEURYSMAL COMPONENT USING ZONE 2 PLACEMENT OF A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT AND DISTAL EXTENSION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). IT WAS NOTED THAT THE AORTIC ARCH HAD A DOUBLE BEND. IT WAS REPORTED THAT THE TBE DEVICE WAS WELL PLACED WITH THE PORTAL AT THE DISTAL EDGE OF THE PATIENT'S LEFT SUBCLAVIAN ARTERY (LSA). THE PROXIMAL END OF THE DEVICE WAS STILL 2-3 CM FROM THE PATIENT'S LEFT COMMON CAROTID ARTERY (LCCA). NO BALLOONING WAS PERFORMED SINCE THIS WAS FOR TREATMENT OF A TYPE B DISSECTION, AND IT WAS REPORTED THAT NO PROXIMAL EXTENSION WAS PERFORMED AS IT DID NOT APPEAR NECESSARY. IT WAS REPORTED THAT THE CTAG A/C DEVICE WAS PLACED DISTALLY AND ENDED IN THE MID-DESCENDING THORACIC AORTA SO AS TO LIMIT AORTIC COVERAGE. THE DISSECTION EXTENDED TO THE CELIAC ARTERY. FINAL ANGIOGRAMS SHOWED CONTINUED FILLING OF THE FALSE LUMEN CREATING A TYPE IB DISSECTION. THE PHYSICIAN CHOSE TO WATCH AND WAIT. ON OR AROUND (B)(6) 2023, FOLLOW-UP CTA IMAGING SHOWED CONTINUED FILLING OF THE FALSE

  Patient problems: Aneurysm expansion

  MAUDE report 17635714 ↗
• DeathAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2023, THIS PATIENT UNDERWENT PART ONE OF A PLANNED STAGED ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL AORTIC ARCH ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TSB081506A/(B)(6)AND TAC083415A/(B)(6)) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGM343420/(B)(6)) USING A GORE® DRYSEAL SHEATH. POST DEPLOYMENT OF THE DEVICES THE PATIENT EXPERIENCED A SHOWER OF EMBOLI DUE TO PLAQUE DISLODGEMENT. EMBOLI AND PLAQUE WERE REPORTED TO TRAVEL DISTALLY AND DEPOSIT WITHIN THE PATIENT¿S ARMS, VISCERAL VESSELS, AND THE DISTAL AORTA. THE PHYSICIAN PERFORMED CUTDOWNS ON THE PATIENT¿S ARMS AND CLEARED AND SUCTIONED OUT CLOTS AND EMBOLI FROM THE VISCERAL VESSELS AND DISTAL AORTA. A RENAL ARTERY WAS STENTED. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE EMBOLI SHOWER WAS REPORTED TO BE DUE TO TORTUOSITY AND A SUBSTANTIAL AMOUNT OF PLAQUE BUILD UP IN THE PATIENT¿S MID DESCENDING THORACIC AORTA. IT WAS REPORTED THAT A GREAT AMOUNT OF MANIPULATION OF THE SHEATH AND DELIVERY CATHETER HAD BEEN REQUIRED TO ADVANCE THE (TAC083415A/(B)(6)) PAST THIS AREA TO GET IT TO PROPERLY LINE UP FOR DEPLOYMENT. IT WAS ESTIMATED T

  Patient problems: Aneurysm

  MAUDE report 17482630 ↗
• InjuryJun 23, 2022Adverse 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® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN A STAGED PROCEDURE PRIOR TO BEING IMPLANTED WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2021, IMAGES REVEALED A RIGHT INNOMINATE DISSECTION. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 14795349 ↗
• DeathMay 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT WAS SEEN FOR ROUTINE FOLLOWUP FOR STAPLE REMOVAL. AT THAT TIME, THE PATIENT COMPLAINED OF BACK PAIN. THE PATIENT WAS SENT TO THE ER, WHERE THEY CODED, AND WERE UNABLE TO BE REVIVED. IMAGING WAS PERFORMED, AND IT WAS SEEN THAT THERE WAS AN AORTIC RUPTURE, MOST LIKELY CAUSED BY A TYPE I ENDOLEAK, ALTHOUGH IT WAS IMPOSSIBLE TO DETERMINE WHICH GRAFT HAD THE ENDOLEAK, AND WHETHER IT WAS PROXIMAL OR DISTAL. NO POST-OP IMAGES ARE AVAILABLE. ACCORDING TO THE PHYSICIAN, THE VIABHANS USED AS CHIMNEYS MAY HAVE CAUSED A GUTTER TYPE 1A ENDOLEAK. THERE WERE VIABHANS USED TO CHIMNEY CELIAC, SMA AND BILATERAL RENALS.

  Patient problems: Pain; Ruptured Aneurysm

  MAUDE report 14462586 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT REPORTED EMERGENTLY WITH A PENETRATING ULCER OF THE AORTA WITH AN INTRAMURAL HEMATOMA THAT EXTENDED TO THE BOWEL. THERE WAS A DISCUSSION OF THE RISKS OF IMPLANTING ENDOGRAFTS IN THE DETERIORATING AORTIC ARCH, BUT THE PHYSICIAN DECIDED TO PROCEED WITH SURGERY. THE PHYSICIAN IMPLANTED TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL. IT WAS FOUND THAT THE AORTIC ARCH HAD CONTINUED TO DETERIORATE. A RETROGRADE TYPE A DISSECTION WAS OBSERVED DISTAL TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PHYSICIAN DECIDED TO DO AN OPEN SURGERY, AND A DACRON GRAFT WAS SEWN TO THE DISTAL END OF THE ENDOGRAFT TO REPAIR THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE EVENT WAS CAUSED BY THE POOR CONDITION OF THE PATIENT'S AORTA, AND WAS UNRELATED TO THE GORE DEVICES. IMAGES WERE RETURNED FOR EVALUATION. THE IMAGES WERE OBTAINED OF THE PATIENT ANATOMY PRIOR TO THE INDEX PROCEDURE, PRIOR TO DEVICE IMPLANTATION, AND THEREFORE, NOT RELEVANT TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13585193 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ACUTE TYPE B DISSECTION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). IT WAS REPORTED THAT POST PROCEDURE THE PATIENT DEVELOPED PARALYSIS. A CSF DRAIN WAS NOT DONE FOR THIS PROCEDURE. THE FSA REPORTED ¿ANESTHESIA HAD ASSURED THE SURGEONS THEY COULD DO ONE, A CSF DRAIN. THE PATIENT WAS TOO UNSTABLE TO TRANSFER TO A HOSPITAL THAT COULD DO A DRAIN AND HAD TO BE TREATED IMMEDIATELY REGARDLESS¿. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Paralysis

  MAUDE report 12523103 ↗
• MalfunctionDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (CTAG-AC) TO TREAT A THORACIC DISSECTION IN ZONE 0 DEPLOYMENT. IT WAS REPORTED THAT WHEN THE PRIMARY DEPLOYMENT LINE WAS PULLED, THE DEVICE DEPLOYED AT 50% AND THE LINE CAME OUT OF THE BACK OF THE DELIVERY HANDLE. THE DISTAL END OF THE DEVICE WAS NOT DEPLOYED, SO THE SECONDARY LINE WAS DEPLOYED, STILL ONLY PARTIAL DEPLOYMENT OF DEVICE BUT THE DEVICE WAS RELEASED FROM THE DELIVERY CATHETER. THE PHYSICIAN USED A PIGTAIL CATHETER AND MANIPULATION WITH A GUIDE WIRE AND WAS ABLE TO DEPLOY THE DEVICE TO FULL DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aortic Dissection

  MAUDE report 11091233 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. PRIOR TO IMPLANT TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) BYPASS OF INNOMINATE ARTERY, THEN BYPASS TO LEFT COMMON CAROTID ARTERY, THEN BYPASS TO LEFT SUBCLAVIAN ARTERY WERE PERFORMED. AFTER THIS WAS COMPLETED THE SURGEON PLANNED TO POSITION A CTAG AC (TGM343420) FOR A ZONE 1 PROXIMAL LANDING. THEN EXTRA CORPORAL PERFUSION OF HEAD VESSELS, REPAIR OF ASCENDING AORTA UTILIZING A 32MM WOVEN GRAFT WITH DISTAL ANASTOMOSIS TO PROXIMAL ASPECT OF (TGM343420). DUE TO CONCERNS OF DISTAL ANASTOMOSIS HEMOSTASIS, THE SURGEON PLANNED TO BRIDGE THE ANASTOMOSIS UTILIZING A SECOND CTAG AC (TGMR373715). THE BYPASSES WERE SUCCESSFULLY COMPLETED VIA MEDIAN STERNOTOMY. THE SURGEON GAINED ARTERIAL ACCESS VIA RIGHT COMMON FEMORAL ARTERY AND PERFORMED WIRE EXCHANGE FOR LUNDERQUIST DOUBLE CURVE EXTRA STIFF WIRE AND THEN A DSF2233 (LOT S/N (B)(4)) WAS SUCCESSFULLY AND UNEVENTFULLY INSERTED. NEXT ANGIOGRAPHIC IMAGING WAS ACQUIRED, AND TGM343420 WAS SUCCESSFULLY DEPLOYED FOR A ZONE 1 PROXIMAL LANDING. SURGEON OPTED TO PRE-POSITION TGMR373715 WITHIN EXISTING CTAG GRAFT. THIS WA

  Patient problems: Aneurysm

  MAUDE report 10706697 ↗
• InjuryOct 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION FROM THE SUBCLAVIAN ARTERY TO THE LEFT VERTEBRAL ARTERY USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL (CTAG/AC). THE DEVICE WAS IMPLANTED THE LEVEL OF THE CAROTID ARTERY, ALTHOUGH THE GORE FIELD SALES ASSOCIATE (FSA) ADVISED AGAINST THIS DUE TO LACK OF APPROPRIATE HEALTHY SEAL ZONE. THE FSA BECAME AWARE ON SEPTEMBER 17, 2020 THAT ON OR ABOUT (B)(6) 2020 A CAROTID ARTERY TO LEFT COMMON CAROTID ARTERY BYPASS WAS PERFORMED IN ORDER TO MAINTAIN PROXIMAL SEAL OF THE CTAG/AC DEVICE. ON (B)(6) 2020, IMAGES WERE READ THAT SHOWED THE PROXIMAL END OF THE MOST PROXIMAL CTAG/AC DEVICE HAD MOVED THROUGH THE SEPTUM OF THE DISSECTION INTO THE FALSE LUMEN. THE PHYSICIAN FEELS THIS MAY HAVE OCCURRED DUE TO THE ORIGINAL POSITIONING OF THE CTAG/AC DEVICE, AND THAT DUE TO THE LACK OF APPROPRIATE SEAL ZONE THE DEVICE "MOVED UP" AND THROUGH THE DISSECTED TISSUE INTO THE FALSE LUMEN. NO REINTERVENTION IS SCHEDULED AT THIS TIME AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aortic Dissection

  MAUDE report 10678590 ↗
• MalfunctionJul 31, 2020Physical Resistance/Sticking; Difficult or Delayed Separation; Difficult or Delayed Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020 THIS PATIENT UNDERWENT OPEN SURGERY TO TREAT A TYPE B DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PROCEDURE WAS AN ARCH REPLACEMENT WITH ELEPHANT TRUNK WITH THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM BEING PLACED DIRECTLY INTO THE ELEPHANT TRUNK. AFTER THE PHYSICIAN PLACED THE DEVICE, WHILE ATTEMPTING TO REMOVE THE ANGULATION MECHANISM, THE RED LOCKWIRE HANDLE CAME HALF WAY OFF AND BECAME STUCK ON THE DELIVERY HANDLE. THE PHYSICIAN PULLED WITH GREATER FORCE, BUT THE LOCKWIRE HANDLE WAS UNABLE TO BE REMOVED. THE PHYSICIAN DECIDED TO CUT THE WIRE AT THE TRAILING END OF THE DEVICE, BUT WAS STILL UNABLE TO REMOVE THE LOCK PIN MECHANISM. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS GENTLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER GORE® TAG® CONFORMABLE THORACIC STENT GRAFT. SECOND DEVICE PLACEMENT WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient; Vascular Dissection

  MAUDE report 10351701 ↗

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-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