GORE DRYSEAL FLEX Introducer Sheath DSF2265Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00733132628384), received between Jun 11, 2019 and Aug 6, 2026 — classified as 1 death, 26 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K160254); 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Patient Device Interaction Problem

  The following information was reported to Gore:On (b)(6) 2026, a patient underwent a total arch replacement with the elephant trunk technique to treat a thoracic aortic aneurysm.On (b)(6) 2026, the patient underwent endovascular treatment using GORE® DRYSEAL Flex Introducer Sheath and GORE TAG Conformable Thoracic Stent Grafts with ACTIVE CONTROL System (CTAGAC) devices. The devices were deployed continuously with the elephant trunk.The sheath and CTAGAC were difficult to advance into the elephant trunk due to the steepness of the arch. The physician attempted to hold the sheath under the elephant trunk and to advance the CTAGAC when a dissection formed in the descending aorta associated with the tip of the sheath.The primary entry was closed with the CTAGAC. The false lumen flow was resolved. However, re-entry was still observed in the ventral branch. No special treatment was performed for re-entry.The patient tolerated the procedure.

  Patient problems: Vascular Dissection

  MAUDE report 50151330 ↗
• InjuryJan 16, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A THORACIC ARCH AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES, GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (RIBS PROCEDURE). AFTER TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES WERE ADVANCED THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND IMPLANTED, THE BLOOD PRESSURE DROPPED. UPON PERFORMING AN ANGIOGRAPHY OF THE DESCENDING AORTA, A DISSECTION WAS IDENTIFIED AT THE DISTAL TORTUOUS SEGMENT OF THE DESCENDING AORTA. A NON-GORE STENT GRAFT AND A NON-GORE PETTICOAT DEVICE WERE IMPLANTED TO COVER THE DISSECTION. AFTERWARDS, THE BLOOD PRESSURE BECAME STABLE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THERE WAS RESISTANCE AT THE SITE WHERE THE DISSECTION WAS IDENTIFIED WHEN THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED. THE PHYSICIAN ALSO STATED THAT AN ANGIOGRAPHY PERFORMED BEFORE THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES WERE IMPLANTED WAS RE-REVIEWED, AND IT

  Patient problems: Vascular Dissection

  MAUDE report 24091321 ↗
• InjuryDec 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACIC AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). A 22 FR DSF SHEATH WAS INSERTED FROM THE RIGHT SIDE AND TWO CTAG ACS WERE IMPLANTED SUCCESSFULLY. AN ANGIOGRAPHY FOR THE ACCESS VESSEL SHOWED VASCULAR INJURY ON THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS UNABLE TO BE DETERMINED IF DISSECTION OR RUPTURE. A COVERED STENT WAS ADDITIONALLY IMPLANTED ON THE INJURED SITE. ALSO, IT WAS CONFIRMED THAT BLOOD FLOW INTO THE LEFT LOWER EXTREMITY DISAPPEARED DURING CLOSING THE SURGICAL INCISION AT THE LEFT FEMORAL ARTERY. DISSECTION WAS FOUND ON THE LEFT EXTERNAL ILIAC ARTERY, SO TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, ON THE LEFT SIDE, NO GORE DEVICES TRAVERSED THE EXTERNAL ILIAC ARTERY, BUT NON-GORE DEVICES DID.

  Patient problems: Perforation of Vessels

  MAUDE report 23800042 ↗
• InjuryOct 16, 2025Adverse 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) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN IMPENDING RUPTURE OF A THORACIC AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AFTER DEPLOYMENT OF THE STENT GRAFT, ANGIOGRAPHY OF THE ACCESS SITE REVEALED THROMBUS FORMATION IN THE EXTERNAL ILIAC ARTERY. THE THROMBUS WAS REMOVED BY ASPIRATION THROUGH THE DSF AND THE USE OF A PTA BALLOON. THE PHYSICIAN REPORTED THAT THE THROMBUS FORMATION WAS DUE TO A DELAY IN THE TIMING OF HEPARINIZATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23319585 ↗
• InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). TWO-DEBRANCHING PROCEDURES WERE PERFORMED AS CONCOMITANT PROCEDURE. AFTER DEPLOYMENT OF THE FIRST CTAG, DURING INSERTION OF THE SECOND CTAG (AFTER SLEEVE CUTTING), THE FIRST CTAG MIGRATED APPROXIMATELY 2 CM PROXIMALLY. THE DSF WAS EXCHANGED FOR A 65 CM DSF, AND THE SECOND CTAG WAS DEPLOYED. A SMALL PROXIMAL TYPE I ENDOLEAK WAS OBSERVED BUT WAS MANAGED WITH OBSERVATION. UPON DSF REMOVAL, DISSECTIONS OF THE RIGHT COMMON ILIAC ARTERY AND RIGHT INTERNAL ILIAC ARTERY WERE IDENTIFIED. THE DISSECTIONS WERE SURGICALLY REPAIRED.

  Patient problems: Vascular Dissection

  MAUDE report 22960724 ↗
• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ASCENDING AORTIC ARCH REPLACEMENT USING THE ELEPHANT TRUNK TECHNIQUE. ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. TWO CTAGS WERE DEPLOYED JUST BELOW THE BRANCH OF THE ARTIFICIAL BLOOD VESSEL. ON AN UNKNOWN DATE, A FOLLOW-UP CT SCAN REVEALED A TYPE I ENDOLEAK ON THE LESSER CURVATURE SIDE OF THE DISTAL CTAG. ADDITIONALLY, THE DISTAL CTAG WAS SUSPECTED TO HAVE MIGRATED TOWARDS THE PROXIMAL SIDE. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED AS A TREATMENT FOR THE ENDOLEAK (THIS EVENT WILL BE CAPTURED IN (B)(4)). A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED ON THE PREOPERATIVE CT SCAN. IT WAS CONSIDERED TO HAVE OCCURRED DURING THE PROCEDURE ON (B)(6) 2024, BUT NO SPECIFIC TREATMENT WAS PERFORMED. IT HAS NOT BEEN IDENTIFIED WHICH DEVICE CAUSED THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 22007636 ↗
• InjuryFeb 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH(DSF SHEATH) AS AN ACCESSORY IN THE PROCEDURE. THE DSF SHEATH WAS INTRODUCED FROM LEFT SIDE. REPORTEDLY, A VESSEL DAMAGE IN THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED ON AN ACCESS CONFIRMATION ANGIOGRAPHY. A STENT GRAFT WAS PLACED TO TREAT THE VESSEL DAMAGE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 21318481 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTA ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH(DSF SHEATH) AS AN ACCESSORY IN THE PROCEDURE. AFTER CLOSED WOUND, IT WAS OBSERVED THAT THE RIGHT LOWER EXTREMITY WAS PALE. OCCLUSION BELOW THE KNEE WAS CONFIRMED ON THE CONFIRMATION ANGIOGRAPHY. THROMBECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT IT IS VERY LIKELY THAT THE THROMBUS MAY HAVE DISPERSED TO THE DISTAL DURING REMOVING THE DSF SHEATH.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21249250 ↗
• InjuryNov 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC (ARCH) AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) AS AN ACCESSORY. THE PHYSICIAN ATTEMPTED TO RAISE THE 22FR DSF FROM THE RIGHT SIDE BUT WAS UNABLE TO INSERT IT DUE TO THE NARROWNESS OF THE ACCESS VESSEL. AS AN ALTERNATIVE, AN EDWARDS ESHEATH INTRODUCER SET (ESHEATH) WAS UTILIZED, AND THE PROCEDURE WAS COMPLETED IN ACCORDANCE WITH THE ORIGINAL PLAN. AN ACCESS ANGIOGRAPHY WAS PERFORMED AT THE TIME OF ESHEATH REMOVAL, WHICH CONFIRMED THE RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY. TWO ADDITIONAL GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WERE PLACED FOR REPAIR, AND THE PROCEDURE WAS COMPLETED ONCE IT WAS CONFIRMED THAT NO BLOOD HAD LEAKED OUTSIDE THE VESSEL. THE PHYSICIAN REPORTEDLY STATED THE FOLLOWING: THE SHEATH WAS INSERTED BY FORCE BECAUSE THE ACCESS VESSELS WERE GENERALLY NARROW AND PARTIALLY STENOTIC IN SOME AREAS. REPORTEDLY, THE OUTER DIAMETER OF THE DSF USED IN THIS CASE WAS 8.2 MM, WHEREAS THE VESSEL DIAMETER OF THE ACCESS VESSEL WAS 4.4~8.5 MM.

  Patient problems: Perforation of Vessels

  MAUDE report 20813636 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE TREATMENT, A 65 CM DSF WAS USED FROM LEFT ACCESS WITH PERCLOSE. A RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED. FOR TREATMENT, AFTER SWITCHED TO A 33 CM DSF, A STENT GRAFT WAS IMPLANTED. REGARDING THE DISTAL ACCESS VESSEL, A RUPTURE AROUND THE INSERTION SITE WAS OBSERVED AND SURGICALLY REPAIRED. AN ANGIOGRAPHY REVEALED THAT FLOW WAS FINE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE ACCESS VESSEL WAS FRAGILE.

  Patient problems: Perforation of Vessels

  MAUDE report 20742080 ↗
• InjuryJul 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH RETROGRADE IN SITU BRANCH SURGERY (RIBS) FOR TWO THORACIC AORTIC ANEURYSMS (ONE IN AORTIC ARCH AND ONE IN DESCENDING AORTA) USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND NON-GORE STENT GRAFT (ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT, COOK MEDICAL JAPAN). GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND GORE® VIABAHN® ENDOPROSTHESIS WERE USED AS THORACIC BRANCH GRAFTS. A 22FR×65CM GORE® DRYSEAL FLEX INTRODUCER SHEATH (SHEATH) WAS USED FOR THE PROCEDURE, AND WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. AFTER ALL PLANNED STENT GRAFTS WERE IMPLANTED, THE PHYSICIAN ROUGHLY WITHDREW THE SHEATH WITHOUT DILATOR AFTER WHICH THE BLOOD PRESSURE DECREASED. THE PHYSICIAN PERFORMED ANGIOGRAPHY WHILE OCCLUDING THE ACCESS VESSEL WITH A BALLOON CATHETER. THE ANGIOGRAPHY CONFIRMED THAT THE ACCESS VESSEL JUST ABOVE THE INSERTION SITE HAD BEEN DAMAGED. AS A TREATMENT, A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED AND LINED WITH A S.M.A.R.T® STENT (CORDIS JAPAN) TO SUCCESSFULLY SEAL THE DAMAGED PART OF THE VESSEL. REPORTEDLY, THIS EVENT REQUIRED 6 UNITS OF BLOOD TRANSFUSION. THE PATIENT TOLER

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 19672196 ↗
• InjuryMay 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A DISTAL ANASTOMOSIS PSEUDOANEURYSM (INFECTED ANEURYSM), WHICH OCCURRED AFTER A TOTAL ARCH REPLACEMENT AND AN ELEPHANT TRUNK, USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. THERE WAS RESISTANCE AT NEAR THE RIGHT COMMON ILIAC ARTERY BUT THE SHEATH WAS ABLE TO BE ADVANCED. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY TO THE ACCESS REVEALED A LOCALIZED DISSECTION AT NEAR THE BIFURCATION OF THE RIGHT ILIAC ARTERY. A STENT (SMART) WAS IMPLANTED TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 19368622 ↗
• InjuryMay 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR RUPTURED TYPE B AORTIC DISSECTION USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE DSF WAS INSERTED FROM THE RIGHT-SIDE ACCESS. AFTER STENT GRAFT DEPLOYMENT, DISSECTION WAS OBSERVED IN THE RIGHT ACCESS VESSEL. AN ADDITIONAL STENT GRAFT WAS DEPLOYED IN THE DISSECTION SITE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THE FOLLOWING. THE PATIENT DEVELOPED DISSECTION AND THE AGE WAS 88, THE BLOOD VESSEL MIGHT HAVE TO BE QUITE FRAGILE. THERE WAS NO RESISTANCE WHEN INSERTING THE SHEATH, AND THE INSERTION WAS SMOOTH.

  Patient problems: Vascular Dissection

  MAUDE report 19328730 ↗
• InjuryMar 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH RETROGRADE IN-SITU BRANCHED STENT GRAFTING (RIBS) TECHNIQUE OF A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE TREATMENT, A 22 FR DSF WAS USED FROM RIGHT ACCESS. AFTER ALL DEVICES WERE IMPLANTED, AN ACCESS ANGIOGRAPHY REVEALED A RUPTURE OF RIGHT EXTERNAL ILIAC ARTERY. ADDITIONALLY A STENT GRAFT WAS IMPLANTED TO TREAT THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT A RESISTANCE WAS FELT WHEN ADVANCING THE DSF AND THE ACCESS VESSEL DAMAGE WAS EXPECTED.

  Patient problems: Perforation of Vessels

  MAUDE report 18966655 ↗
• InjuryMar 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A AORTIC DISSECTION. AFTER CREATING PULL-THROUGH WIRE FROM THE RIGHT AXILLARY ARTERY THROUGH THE RIGHT FEMORAL ARTERY, A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, BUT WAS WITHDRAWN SINCE THE TIP OF THE SHEATH GOT SQUASHED. THE PROCEDURE WAS CONTINUED USING ANOTHER SHEATH. AFTER THE STENT GRAFT WAS IMPLANTED, A DISSECTION AT THE INSERTION SITE WAS OBSERVED. THE DISSECTION WAS TREATED BY SURGICALLY AND THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE DISSECTION MIGHT HAVE BEEN CAUSED BY THE PULL-THROUGH WIRE WAS NOT FIRMLY TENSIONED AND SAGGING.

  Patient problems: Vascular Dissection

  MAUDE report 18854075 ↗
• InjuryOct 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. A DSF1833 WAS INSERTED THROUGH THE LEFT FEMORAL ARTERY AND PASSED THROUGH THE LEFT COMMON ILIAC ARTERY, ALTHOUGH THERE WAS SOME RESISTANCE DURING PASSAGE. AFTER IMPLANTING A CXA280005, THE SHEATH WAS REPLACED WITH A DSF2265, AND THE DSF2265 WAS INSERTED ALTHOUGH THERE WAS SOME RESISTANCE. ACCESS ANGIOGRAPHY AFTER ALL STENT GRAFTS IMPLANTATION REVEALED DISSECTION OF THE LEFT COMMON ILIAC ARTERY, BUT NO TREATMENT WAS PERFORMED SINCE THERE WAS NO BLEEDING. THE PATIENT WAS PLACED UNDER OBSERVATION. REPORTEDLY, THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY IN THE AREA WHERE DISSECTION OCCURRED WAS REPORTED TO BE ABOUT 6.1-7.1 MM. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: BECAUSE THE PATIENT'S ACCESS VESSEL WAS ORIGINALLY NARROW, DISSECTION WAS CONSIDERED UNAVOIDABLE.

  Patient problems: Vascular Dissection

  MAUDE report 17958605 ↗
• InjurySep 18, 2023Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method; Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, PRIOR TO PERFORMING A TRANSCATHETER AORTIC VALVE IMPLANTATION(TAVI), THE PHYSICIAN BEGAN ENDOVASCULAR TREATMENT OF A MURAL THROMBUS IN A PRE-EXISTING NON-GORE STENT GRAFT. GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSF) WERE USED FOR ACCESS FOR THE TEVAR. FIRST, A 22FR DSF WAS INSERTED INTO THE LEFT COMMON FEMORAL ARTERY. HOWEVER, THE PHYSICIAN FELT RESISTANCE, AND COULD NOT ADVANCE THE SHEATH. THE DEVICE WAS REPLACED WITH A 20FR DSF, BUT IT COULD NOT BE ADVANCED EITHER. A VESSEL RUPTURE WAS THEN OBSERVED ON THE ANGIOGRAPHY. TO TREAT THE RUPTURE, TWO STENT GRAFTS WERE PLACED FROM THE LEFT COMMON ILIAC ARTERY DOWN TO THE LEFT EXTERNAL ILIAC ARTERY; HOWEVER, IT WAS CONFIRMED THAT THE RUPTURE SITE WAS LOCATED MORE DISTAL THAN THE DISTAL STENT GRAFT. THE PHYSICIAN THEN ELECTED TO PERFORM TAVI WITHOUT PERFORMING TEVAR. AFTER THE TAVI WAS COMPLETED, THE RUPTURE SITE WAS TREATED SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THERE WAS A CALCIFICATION IN THE DISTAL PART OF LEFT EXTERNAL ILIAC ARTERY, AND THE DIAMETER OF THE DISTAL END OF THE EXTERNAL ILIAC ARTERY WAS APPROXIMATELY 7MM.

  Patient problems: Perforation of Vessels

  MAUDE report 17766019 ↗
• InjuryAug 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT 2 DEBRANCHING TEVAR FOR ANEURYSM ENLARGEMENT DUE TO FAILURE OF NON-GORE ARTIFICIAL VASCULAR ANASTOMOSIS USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. WHILE ADVANCING THE SHEATH, A RESISTANCE WAS FELT. A DISSECTION FROM RIGHT EXTERNAL ILIAC ARTERY THROUGH RIGHT FEMORAL ARTERY WAS OBSERVED UPON WITHDRAWING THE SHEATH. FEMORAL-FEMORAL BYPASS WAS PERFORMED TO TREAT THE DISSECTION. THE DIAMETER OF THE REIA WAS REPORTEDLY APPROXIMATELY 8.3 TO 9.1MM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17470836 ↗
• InjuryJul 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM FOR DESCENDING AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT'S ACCESS VESSEL HAD MANY THROMBOSIS AND CALCIFICATION PRIOR TO THE PROCEDURE, AND THE LUMEN WAS NARROW. WHEN THE DSF WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, THERE WAS CONSIDERABLE RESISTANCE. AFTER REMOVING THE DSF, ONLY THE DILATOR WAS INSERTED, THEN THE DSF WAS INSERTED AGAIN. THE STENT GRAFT WAS DEPLOYED WITHOUT REPORTED ISSUES, AND THE DSF WAS REMOVED. ANGIOGRAPHY CONFIRMED THE OUTFLOW OF THE CONTRAST AGENT IN THE RIGHT EXTERNAL ILIAC ARTERY. THE RUPTURE AREA WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. CODE 5400-C USED TO CAPTURE SURGICAL REPAIR OF RIGHT EXTERNAL ILIAC ARTERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stenosis; Thrombosis/Thrombus

  MAUDE report 17295008 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 , THIS PATIENT UNDERWENT A STAGED PROCEDURE FOR AN ARCH AORTIC ANEURYSM. TOTAL ARCH REPLACEMENT AND ELEPHANT TRUNK TECHNIQUE WAS PERFORMED ON THIS DAY AND STENT GRAFT PLACEMENT WAS PLANNED FOR THE NEXT DAY (B)(6) 2022. ON (B)(6) 2022 , USING GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSFS), IMPLANT OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG ACS) WAS CONDUCTED. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE 22 FR DSF SHEATH, STRONG RESISTANCE FORCE WAS OBSERVED AND INSERTION COULD NOT BE MADE. A 20 FR DSF SHEATH WAS USED TO DILATE THE ACCESS VESSELS AND THEN, THE 22 FR DSF SHEATH WAS SUCCESSFULLY DELIVERED TO THE TARGETED SITE. THE PROXIMAL CTAG AC WAS DEPLOYED SUCCESSFULLY. WHEN THE BALLOON CATHETER WAS INFLATED INSIDE THE CTAG AC DEVICE, IT MOVED DISTALLY PROBABLY DUE TO BLOOD FLOW. NO ENDOLEAK WAS FOUND AFTER THE MIGRATION AND THEREFORE NO TREATMENT WAS NEEDED. THE DISTAL CTAG AC WAS PLACED WITHOUT ANY PROBLEMS. AFTER WITHDRAWING THE DSF SHEATH, A LOCALIZED DISSECTION WAS FOUND NEAR THE BIFURCATION POINT OF THE LEFT ILIAC ARTERY. A BARE-METAL STENT (SMART, 8.0 MM X 60 MM) WAS ADDITIONALLY IMPLANTED AT THE DISSECTED SITE. THE PATIENT TO

  Patient problems: Vascular Dissection

  MAUDE report 15968490 ↗
• InjuryNov 17, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ARCH AORTIC SACCULAR ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WITH 1 DEBRANCH BYPASS. THE 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE. AFTER ALL DEVICES WERE IMPLANTED, UPON CLOSURE OF THE ACCESS SITE, IT WAS OBSERVED THAT BLOOD FLOW OF THE RIGHT DISTAL ARTERY WAS POOR. ANGIOGRAPHY REVEALED A RIGHT ILIAC ARTERY DISSECTION. TWO STENTS (SMART) WERE IMPLANTED TO TREAT THE DISSECTION. THE DISSECTION WAS RESOLVED, AND THE BLOOD FLOW IMPROVED. THE PHYSICIAN STATED THAT AN ANGIOGRAPHY FOR THE ACCESS SITE BEFORE CLOSURE WAS NOT CLEAR AND THE EVALUATION OF THE ACCESS SITE MIGHT HAVE NOT BEEN SUFFICIENT. THE PHYSICIAN SUGGESTED THAT THE DISSECTION MIGHT HAVE OCCURRED WHEN THE SHEATH WAS ADVANCED.

  Patient problems: Vascular Dissection

  MAUDE report 12828879 ↗
• InjuryJul 16, 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) 2021, THIS PATIENT UNDERWENT DEBRANCH ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH FOR AN AORTIC ARCH ANEURYSM. THE PLANNED ACCESS ROUTE WAS THE RIGHT FEMORAL ARTERY, BUT THE PHYSICIAN MISTAKENLY INSERTED THE SHEATH FROM THE RIGHT SUPERFICIAL FEMORAL ARTERY. HOWEVER, THE PROCEDURE WAS CONTINUED WITHOUT BEING NOTICED ABOUT THE MISTAKE. AFTER ALL PROCEDURES WERE COMPLETED AND THE SHEATH WAS REMOVED, DISSECTION AT THE SITE OF SHEATH INSERTION WAS REVEALED BY ABNORMAL BLOOD PRESSURE, AND THE SITE OF THE SHEATH INSERTION WAS FOUND TO BE THE RIGHT SUPERFICIAL FEMORAL ARTERY, NOT THE RIGHT FEMORAL ARTERY. REPLACEMENT OF THE DISSECTED PART WAS PERFORMED FOR REPAIR. THE PHYSICIAN REPORTEDLY STATED AS BELOW: A YOUNG, INEXPERIENCED PHYSICIAN PERFORMED THE INSERTION PART OF THE PROCEDURE, AND MADE A MISTAKE IN THE INSERTION SITE.

  Patient problems: Vascular Dissection

  MAUDE report 12180921 ↗
• InjuryMay 14, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE¿ TAG¿ CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A 22FR GORE¿ DRYSEAL FLEX INTRODUCER SHEATH. THE GORE¿ DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT ACCESS. MEASUREMENTS OF THE LEFT ACCESS VESSEL WAS APPROXIMATELY 7MM. AFTER THE GORE¿ TAG¿ CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED, AND AFTER THE ACCESS SITE WAS CLOSED, THE PHYSICIAN NOTICED THERE WAS NO PULSE IN THE LEFT LIMB. AN ANGIOGRAPHY IMAGING REVEALED THAT THERE WAS NO BLOOD FLOW IN THE LEFT COMMON FEMORAL ARTERY TO THE LEFT SUPERFICIAL FEMORAL ARTERY. A DISSECTION WAS OBSERVED AT THE ACCESS SITE AND AN ENDARTERECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11826131 ↗
• InjuryOct 12, 2020Use of Device Problem; Use of Device Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ARCH AORTA ANEURYSM AND AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS UTILIZING GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSF). THE DSF2265 WAS INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY. WHILE ADVANCING AT THE RIGHT EXTERNAL ILIAC ARTERY, A STRONG RESISTANCE WAS FELT SINCE THE RIGHT EXTERNAL ILIAC ARTERY WAS TORTUOUS, BUT THE PROCEDURE WAS CONTINUED. WHEN THE DSF2265 WAS REMOVED, THE PATIENT'S BLOOD PRESSURE WAS DECREASED, AND THE INTRA-OPERATIVE IMAGING REVEALED A VESSEL DAMAGE AT THE RIGHT EXTERNAL ILIAC ARTERY. AN ADDITIONAL STENT GRAFT WAS PLACED TO COVER THE VESSEL DAMAGED AREA AND THE PRESSURE HEMOSTASIS WAS PERFORMED USING OCCLUSION BALLOON. THE EXACT VESSEL MEASUREMENT AT THE RIGHT SIDE WHERE THE VESSEL DAMAGE OCCURRED IS UNKNOWN, BUT THE PROXIMAL SIDE WAS 9.1MM AND THE DISTAL SIDE WAS 10.1MM. ACCORDING TO THE PHYSICIAN, THE LANDING PLACE WAS TORTUOUS THAT MIGHT BE CAUSED THE EVENT. THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10665252 ↗
• DeathSep 30, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE ¿PULL-THROUGH¿ TECHNIQUE BETWEEN THE RIGHT BRACHIAL ARTERY AND THE LEFT COMMON FEMORAL ARTERY WAS USED BECAUSE THE SITE OF THE EXISTING ELEPHANT TRUNK GRAFT IN THE TRANSVERSE AORTA WAS SEVERELY TORTUOUS. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO THE LEFT COMMON FEMORAL ARTERY BECAUSE THE ACCESS VESSEL WAS REPORTEDLY CALCIFIED. THE 22FR SHEATH WAS ADVANCED FROM THE LEFT COMMON FEMORAL ARTERY UP TO THE LEVEL OF THE ELEPHANT TRUNK, BUT REPORTEDLY WOULD NOT CROSS THE ANASTOMOSIS SITE DUE TO VESSEL TORTUOSITY. ACCORDING TO THE REPORT, THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED OUTSIDE THE SHEATH AND WAS SUCCESSFULLY NAVIGATED THROUGH THE ANASTOMOSIS SITE. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED SUCCESSFULLY AT THE TARGET LOCATION. THE GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS WAS THEN SUCCESSFULLY IMPLANTED D

  Patient problems: Death; Embolism; No Code Available

  MAUDE report 10607327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160254. One submission often covers many models, so check the product and lot details in each record.

• Z-1962-2020 · Nov 18, 2019 · Terminated
  Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.