GORE TAG Conformable Thoracic Endoprosthesis TGU343415Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132618156), received between Sep 1, 2018 and May 17, 2024 — classified as 4 deaths, 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2016, A PATIENT UNDERWENT TREATMENT OF A TYPE B UNCOMPLICATED AORTIC DISSECTION WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2016, A CTA REVEALED THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 51MM. ON (B)(6) 2016, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. IT WAS UNKNOWN WHAT DEVICE WAS INVOLVED IN A TYPE I ENDOLEAK. THE CAUSE OF ENDOLEAK WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER WAS NOT AVAILABLE. REPORTEDLY, ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE AND AN ADDITIONAL ENDOGRAFT (UNKNOWN) WAS IMPLANTED. PER MEDICAL DEVICE TRACKING, NO ADDITIONAL GORE DEVICES WERE RECORDED. REPORTEDLY, OVER TIME THE ANEURYSMAL SIZE GREW TO 59 MM. FROM (B)(6) 2017 TO (B)(6) 2018 CTA REVEALED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 54MM TO 74MM. ON (B)(6) 2017, THE COIL EMBOLIZATION OF OUTFLOW VESSEL TO THORACIC AORTA FALSE LUMEN WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT BE CONTINUED TO HAVE AORTIC ENLARGEMENT. REPORTEDLY, ON (B)(6) 2018, THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR DUE TO THE ANEURYSM ENLARGEMENT. THE INITIAL ENDOG

  Patient problems: Aneurysm expansion; Pseudoaneurysm; Unspecified Infection

  MAUDE report 19347707 ↗
• InjuryNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343415/10456518). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE ENDOLEAK AND A SNORKEL PROCEDURE WAS PERFORMED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX) WAS DEPLOYED WITHIN THE LEFT COMMON CAROTID AND THE ORIGINAL DEVICES WERE RELINED WITH THREE ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. NO ANEURYSM ENLARGEMENT WAS REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 18243192 ↗
• InjuryDec 2, 2022Leak/Splash; Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. AS REPORTED, ON (B)(6) 2022, THE PATIENT PRESENTED WITH A POSSIBLE TYPE II OR TYPE III ENDOLEAK. AS REPORTED, THERE IS SOME CONCERN OVER ACCESS SITES ON THE PATIENT SO AN ANGIOGRAM IS BEING PLANNED IN ORDER TO DETERMINE THE TYPE OF LEAK AND BEST ACCESS AND DEVICE FOR USE IN TREATMENT. AS REPORTED, A REINTERVENTION WILL BE SCHEDULED BASED ON THE RESULTS.

  Patient problems: Clinical Endoleak; Insufficient Information

  MAUDE report 15911482 ↗
• InjurySep 16, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2013, THIS PATIENT UNDERWENT TREATMENT OF A PENETRATING AORTIC ULCER, A TYPE B UNCOMPLICATED AORTIC DISSECTION AND AN INTRAMURAL HEMATOMA. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED WITHIN THE DESCENDING THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, A NEW ONSET DESCENDING AORTIC DISSECTION WAS IDENTIFIED DISTAL TO THE DEVICE. THE PHYSICIAN IS MONITORING THE PATIENT WITH SERIAL CTA. ON (B)(6) 2022, A NEW AORTIC DISSECTION WAS REPORTED FOR THE PATIENT. THE PATIENT UNDERWENT REINTERVENTION THIS DATE, AND AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED. THE INFORMATION INDICATES THE PATIENT EXPIRED THIS DATE AND THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 15440065 ↗
• DeathJun 11, 2020Adverse 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) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION IN (ZONE 0/1), AND WAS IMPLANTED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020 RAPID EXPANSION OF THE AORTIC ARCH, PROXIMAL AND DISTAL DESCENDING AORTA AND VISCERAL SEGMENT WERE REPORTED. THIS RAPID EXPANSION WAS NOT WITHIN THE TREATMENT ZONE. IT WAS ADJACENT TO THE CTAG DEVICE. RETROGRADE FLOW INTO THE FALSE LUMEN AT THE LEVEL OF THE SUPRACELIAC AORTA WAS ALSO REPORTED. OPEN THORACOABDOMINAL REPAIR WITH LEFT HEART BYPASS WAS PERFORMED BUT THE PATIENT DEVELOPED PROFOUND HYPOTENSION AND VENTRICULAR FIBRILLATION. DESPITE DEFIBRILLATION AND CARDIAC COMPRESSIONS, THE PATIENT EXPIRED INTRAOPERATIVELY DUE TO EXSANGUINATION.

  Patient problems: Aneurysm; Death; Vascular Dissection

  MAUDE report 10146005 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A TYPE B AORTIC DISSECTION. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES (DATE UNKNOWN), REVEALED A DISTAL TYPE I ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND IMPLANTED TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND EXTENDED PROXIMALLY AND DISTALLY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Vascular Dissection

  MAUDE report 9462372 ↗
• InjuryDec 9, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THIS PATIENT UNDERWENT A FROZEN ELEPHANT TRUNK PROCEDURE TO TREAT AN ASCENDING THORACIC AORTIC ANEURYSM THAT EXTENDED INTO THE DESCENDING THORACIC AORTA. AFTER THE FROZEN ELEPHANT TRUNK PORTION OF THE PROCEDURE, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED IN THE DESCENDING THORACIC AORTA. ON (B)(6) 2019, THE CARDIOVASCULAR SURGEON NOTICED A SLIGHT "BIRD BEAK" AT THE DISTAL END OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS DURING FOLLOW UP IMAGING. THE SURGEON DID NOT KNOW WHY THE "BIRD BEAK" WAS PRESENT. AS THE SURGEON WAS CONCERNED ABOUT FUTURE ISSUES THAT COULD BE CAUSED BY THE "BIRD BEAK", HE DECIDED TO EXTEND THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ANOTHER CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343410). THE "BIRD BEAK" WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437518 ↗
• InjuryDec 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING THREE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2019, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED ON FOLLOW UP. THERE WAS NO ANEURYSM ENLARGEMENT. THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION ALONG WITH ¿BIRD BEAKING¿ AT THE DISTAL END OF THE DEVICE. THE DEVICE DID NOT TAKE THE CURVE OF THE AORTA, THEREFORE CONTRIBUTING TO THE ENDOLEAK. ON (B)(6) 2019, A REINTERVENTION OCCURRED WHEREBY TWO GORE® TAG® THORACIC ENDOPROSTHESES WITH ACTIVE CONTROL WERE IMPLANTED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403037 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN UNKNOWN CONDITION. THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A RETROGRADE TYPE A DISSECTION. THE REASON FOR THE ORIGINAL PROCEDURE IS UNKNOWN. DISSECTION WAS RESOLVED WITH A TOTAL ARCH REPLACEMENT INTO THE EXISTING CTAG DEVICE. THE PHYSICIAN HAS NO OPINION REGARDING THE CAUSE OF THE DISSECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 9225462 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU454515/20336442). A CAROTID SUBCLAVIAN BYPASS WAS ALSO DONE AND A 14 MM & 12 MM AMPLATZER PLUG WAS PLACED IN THE LEFT SUBCLAVIAN OSTIUM ABOVE THE GRAFT AND THE GRAFT WAS DEPLOYED AT THE BOVINE ARCH. IT WAS REPORTED NO SPINAL DRAIN WAS PLACED BUT NEURO MONITORING WAS DONE. THE PATIENT WAS MOVING LEGS FOLLOWING THE PROCEDURE. THE PHYSICIAN WAS CALLED THE NEXT DAY AND THE PATIENT WAS PRESENTING WITH PARALYSIS. A SPINAL DRAIN WAS PUT IN TO RELIEVE SYMPTOMS AND THE HOSPITAL IS WORKING THE PATIENT THROUGH REHAB. THE EVENT IS ONGOING.

  Patient problems: Not Applicable

  MAUDE report 9082985 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2016, A PATIENT UNDERWENT TREATMENT OF A TYPE B UNCOMPLICATED AORTIC DISSECTION WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE MAXIMUM AORTIC DIAMETER SIZE OF THE TREATED AREA IS NOT AVAILABLE. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6), 2016, A CTA REVEALED THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 51MM. FROM (B)(6), 2017 TO (B)(6), 2018 CTA REVEALED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 54MM TO 74MM. ON (B)(6), 2018, A CTA REVEALED THE ANEURYSM MEASURED 36MM. ON (B)(6), 2018, A CTA REVEALED THE ANEURYSM MEASURED 37MM. REPORTEDLY, ON (B)(6), 2017, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE AND AN ADDITIONAL ENDOGRAFT (UNKNOWN) WAS IMPLANTED. ON (B)(6), 2017, A COIL EMBOLIZATION OF OUTFLOW VESSELS TO THE THORACIC AORTA FALSE LUMEN WAS PERFORMED. ON (B)(6), 2017, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE INFORMATION PROVIDED THE EVENT WAS RELATED TO AORTIC DEVICE OR PROCEDURE, HOWEVER THE DEVICE INVOLVED WAS NOT AVAILABLE. REPORTEDLY, ON (B)(6), 2018, THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. IT IS NOT KNOWN WHETHER GORE DEVICES WERE EXPLANTED. ADDITIONALLY, A HEMATOMA WAS NOT

  Patient problems: Aneurysm; Aortic Dissection; Hematoma

  MAUDE report 8839601 ↗
• DeathMay 29, 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) 2015 A PATIENT UNDERWENT TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2017 THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO TREAT AN ACUTE TYPE A AORTIC DISSECTION, POSSIBLY ADJACENT TO THE GORE DEVICE. ON (B)(6) 2017 THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PROCEDURE. THE PHYSICIAN ATTRIBUTES THE TYPE A DISSECTION TO PATIENT LIFESTYLE AND NON-COMPLIANCE.

  Patient problems: Death; Vascular Dissection

  MAUDE report 8652333 ↗
• MalfunctionMay 9, 2019Mechanical Problem; Mechanical Problem

  ON APRIL 10, 2019 A MEDWATCH (MW5085320) WAS SENT VIA EMAIL STATING, ¿EMERGENT SURGERY FOR RUPTURED THORACIC AORTIC ANEURYSM. DETERMINED LATER IN HER STAT THAT LIKELY DELIVERY SYSTEM (OLIVE TIP) OF TEVAR PLACED EMERGENTLY DURING ACTIVE CPR WAS RETAINED AT THE LEVEL OF AORTIC BIFURCATION INTO LEFT COMMON ILIAC ARTERY. NO HARM.¿ FURTHER INFORMATION PROVIDED BY THE PHYSICIAN STATED THE PATIENT WAS INITIALLY A ¿STABLE RUPTURE¿ OF TAAA, WHO UPON BEING IN THE OR FOR A FEW MINUTES, WITH ANESTHESIA PREPARATION, DEVELOPED OVER RUPTURE REQUIRING CPR. DURING THE PROCEDURE THEY PHYSICIAN HAD TO RAPIDLY GAIN ACCESS AND PLACE THE DEVICE. THE SHEATH WAS REPORTED TO BE ONE SIZE SMALLER THAN IDEAL, BUT THE DEVICE WENT UP WITHOUT DIFFICULTY AND WAS DEPLOYED SAVING HER LIFE AT THAT TIME. IT WAS NOT RECOGNIZED AT THAT TIME THAT ANY PROBLEM OCCURRED WITH DEVICE REMOVAL. THE OLIVE TIP WAS RECOGNIZED ONE MONTH LATER ON A CT SCAN. THE OLIVE REMAINED IN THE PATIENT AND REPORTEDLY DID NOT CAUSE ANY ADVERSE OUTCOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8596643 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION IN THE ASCENDING AND DESCENDING THORACIC AORTA. THE PHYSICIAN PLANNED TO PERFORM AN OPEN REPAIR IN THE ASCENDING AORTIC ARCH WITH AN ARTIFICIAL TRUNK. THEN THE PHYSICIAN WAS GOING TO DEPLOY A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PHYSICIAN PLANNED TO SUTURE THE ARTIFICIAL GRAFT TO THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT THE PHYSICIAN UNINTENTIONALLY DEPLOYED THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343415/18748005) IN THE FALSE LUMEN. HE WAS ABLE TO PULL THE DEVICE OUT OF THE FALSE LUMEN, DUE TO THE OPEN REPAIR. THE EXPLANTED GRAFT WAS DESTROYED AT THE HOSPITAL. THE PHYSICIAN THEN IMPLANTED A DIFFERENT CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS IN THE TRUE LUMEN AND WAS ABLE TO SUTURE IT TO THE ARTIFICIAL GRAFT. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON OR AFTER (B)(6) 2018, THE PATIENT EXPIRED DUE TO HYPERKALEMIA WHICH WAS NOT CAUSED OR CONTRIBUTED BY THE USE OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS.

  Patient problems: Vascular Dissection

  MAUDE report 8233133 ↗
• InjuryDec 21, 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) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION IN (ZONE 0/1), AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS USING A GORE AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD SYSTEMIC INFLAMMATORY RESPONSE SYNDROME WITHOUT APPARENT INFECTION. DRUG THERAPY WAS ADMINISTERED AND IT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Vascular Dissection

  MAUDE report 8192413 ↗
• DeathNov 7, 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) 2018 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. AFTER THE PROCEDURE THE PATIENT SUFFERED AN EMBOLIC CEREBROVASCULAR ACCIDENT (CVA). ON (B)(6) 2018 THE PATIENT EXPIRED DUE TO THE CVA.

  Patient problems: Vascular Dissection

  MAUDE report 8047344 ↗
• DeathSep 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ACUTE THORACIC AORTIC DISSECTION USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2018, REVEALED THE ENTRY TEAR WAS AT THE LEFT SUBCLAVIAN ARTERY AS WELL AS A PENETRATING ULCER IN THE DISSECTION PLANE. WHILE ADVANCING THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343415/17690331), DURING DEPLOYMENT THE DEVICE ADVANCED APPROXIMATELY 5MM COVERING THE LEFT CAROTID ARTERY. THE PHYSICIAN WAS ABLE TO USE A GORE® TRI-LOBE BALLOON CATHETER AND PULLED THE DEVICE DISTALLY TO UNCOVER THE LEFT CAROTID ARTERY. THE LEFT CAROTID ARTERY WAS THEN PATENT. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343415/18070192) DISTALLY AND BALLOONED THE OVERLAP. THE PHYSICIAN THEN IMPLANTED A 12MM AMPLATZER¿ VASCULAR PLUG IN THE LEFT SUBCLAVIAN ARTERY AND DISTAL TO THE LEFT VERTEBRAL ARTERY. AN ANGIOGRAM TAKEN FROM THE BRACHIAL ARTERY REVEALED THE LEFT VERTEBRAL ARTERY WAS PATENT. REPORTEDLY AT THE END OF THE PROCEDURE AFTER THE PERCLOSE PROGLIDE WAS UTILIZED, THE RIGHT FOOT WAS COLD. THE PHYSICIAN CHOSE TO OPEN UP THE

  Patient problems: Vascular Dissection

  MAUDE report 7840468 ↗

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