GORE DRYSEAL FLEX Introducer Sheath DSF2033Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00733132630066), received between Aug 9, 2018 and Sep 30, 2026 — classified as 1 death, 75 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (37 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 77 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50950508 ↗
• InjuryJun 12, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT FOR A DISRUPTION AT THE DISTAL ANASTOMOSIS FOLLOWING TOTAL ARCH REPLACEMENT (TAR). THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. REPORTEDLY, RESISTANCE WAS FELT AT THE ACCESS SITE WHEN THE DSF SHEATH WAS INSERTED FROM THE LEFT SIDE; HOWEVER, IT WAS SUBSEQUENTLY ADVANCED SUCCESSFULLY WITHOUT FURTHER ISSUES. VASCULAR DAMAGE IN THE LEFT FEMORAL ARTERY WAS OBSERVED ON ACCESS ANGIOGRAPHY, AND A STENT GRAFT WAS PLACED. ADDITIONALLY, HEMOSTASIS COULD NOT BE ACHIEVED DUE TO VASCULAR INJURY AT THE ACCESS SITE; THEREFORE, SURGICAL REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE ACCESS VESSEL WAS SLIGHTLY NARROW.

  Patient problems: Perforation of Vessels

  MAUDE report 25481467 ↗
• InjuryApr 30, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISSECTION, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY. FOLLOWING DEPLOYMENT OF THE STENT GRAFT, ACCESS VESSEL ANGIOGRAPHY DEMONSTRATED VASCULAR INJURY TO THE RIGHT FEMORAL ARTERY. AS A TREATMENT, A STENT GRAFT WAS IMPLANTED AT THE INJURED SITE, AFTER WHICH THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE ACCESS VESSEL DIAMETER WAS IN THE 6-MM RANGE, WHICH WAS CONSIDERED RELATIVELY SMALL AND THEREFORE ASSOCIATED WITH AN INCREASED RISK OF VASCULAR INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 25053377 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PATIENT PREVIOUSLY HAD ALREADY BEEN IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS IN THE ABDOMINAL AORTA ON AN UNKNOWN DATE. IN THIS TAMBE PROCEDURE, GORE® DRYSEAL FLEX INTRODUCER SHEATH, GORE® TRI-LOBE BALLOON CATHETER, GORE® MOLDING & OCCLUSION BALLOON CATHETER, AND GORE® TRI LUMEN CATHETER (TLC) WERE USED AS ACCESSORY DEVICES. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE USED AS BRANCH COMPONENTS. DURING ESTABLISHMENT OF PULL-THROUGH GUIDEWIRE, A 0.018-INCH GUIDEWIRE COULD NOT BE REMOVED FROM THE TLC CATHETER WITH SIGNIFICANT RESISTANCE FELT. AS THE GUIDEWIRE WAS UNABLE TO BE REMOVED SAFELY, THE TLC CATHETER WAS WITHDRAWN AND EXCHANGED FOR A NEW ONE. AFTER DEPLOYING THE TAMBE DEVICE, CANNULATION TO THE LEFT RENAL ARTERY FROM THE UPPER EXTREMITY APPROACH WAS CHALLENGING DUE TO SUPERIORLY ANGULATED RENAL ARTERY. ALTHOUGH A GUIDEWIRE COULD BE ADVANCED INTO THE LEFT RENA

  Patient problems: Embolism/Embolus

  MAUDE report 24950191 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RIGHT COMMON ILIAC ARTERY ANEURYSM USING A NON-GORE STENT GRAFT (MAIN DEVICE: AFX), GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE NON-GORE STENT GRAFT WAS IMPLANTED IN THE ABDOMINAL AORTA. AN 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED FROM THE RIGHT SIDE, AND THREE AORTIC EXTENDER ENDOPROSTHESES (TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND ONE GORE® EXCLUDER® AAA ENDOPROSTHESIS) WERE IMPLANTED PROXIMALLY. AN ILIAC BRANCH COMPONENT WAS DELIVERED FROM THE RIGHT SIDE AND DEPLOYED. A 14 FR SHEATH WAS INSERTED ALONGSIDE AN 18 FR SHEATH, AND THE IPSILATERAL U TURN TECHNIQUE WAS PERFORMED. ALTHOUGH THE U TURN WAS ACHIEVED, THERE WAS STRONG RESISTANCE AND THE ILIAC BRANCH COMPONENT MIGRATED DISTALLY. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) CONFIRMED THAT THE GATE OF THE ILIAC BRANCH COMPONENT WAS NOT COMPRESSED AT THAT TIME. CANNULATION OF THE INTERNAL ILIAC ARTERY WAS ATTEMPTED USING A RADIFOCUS WIRE AND A KMP CATHETER, AND THE INTERNAL ILIAC ARTERY WAS DILATED USING A PTA BALLOON. THE WIRE WAS THEN E

  Patient problems: Perforation of Vessels

  MAUDE report 24907598 ↗
• InjuryApr 16, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A CHRONIC DISSECTION WITH AN ULCER-LIKE PROJECTION (ULP) USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH. REPORTEDLY, RESISTANCE WAS FELT AT THE RIGHT EXTERNAL ILIAC ARTERY WHEN THE SHEATH WAS INSERTED. SMALL DISSECTIONS WERE OBSERVED IN THE RIGHT COMMON ILIAC ARTERY AND THE RIGHT EXTERNAL ILIAC ARTERY BY ANGIOGRAPHY OF THE ACCESS VESSELS AFTER THE STENT GRAFTS WERE DEPLOYED. BARE METAL STENTS WERE DEPLOYED IN BOTH ARTERIES. THE DISSECTIONS WERE RESOLVED. ALSO, BLEEDING WAS OBSERVED AT THE FEMORAL ARTERY CUTDOWN SITE. THE FEMORAL ARTERY WAS SURGICALLY REPAIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24901910 ↗
• MalfunctionMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, WITH A MODIFIED GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG AND USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN MODIFIED THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG PRIOR TO THE PROCEDURE. WHILE ADVANCING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH, THE SHEATH VALVE PUNCTURED. THERE WAS MINIMAL BLOOD LOSS AND NO NEED FOR A BLOOD TRANSFUSION. THE SHEATH WAS REMOVED AND REPLACED WITH A NEW SHEATH; THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE CAUSE OF THE SHEATH VALVE PUNCTURE IS UNKNOWN, BUT COULD HAVE BEEN A BENT ANCHOR FROM WHEN THE PHYSICIAN MODIFIED THE DEVICE. THIS COULD NOT BE VERIFIED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24485444 ↗
• InjuryFeb 24, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. A 20 FR SHEATH WAS INSERTED THROUGH THE RIGHT FEMORAL ARTERY; HOWEVER, INSERTION WAS NOT POSSIBLE. AFTER VESSEL DILATION WITH AN 8-MM BALLOON, A 16 FR SHEATH WAS INSERTED TO CONFIRM THAT INSERTION WAS FEASIBLE. SUBSEQUENTLY, THE 20 FR SHEATH WAS RE-INSERTED; ALTHOUGH INSERTION RESISTANCE WAS ENCOUNTERED, DELIVERY WAS POSSIBLE. ACCESS VESSEL ANGIOGRAPHY PERFORMED AFTER STENT GRAFT PLACEMENT REVEALED INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY AND THE PRESENCE OF AN ARTERIOVENOUS FISTULA RESULTING FROM THE INJURY. AS A TREATMENT, A STENT GRAFT WAS IMPLANTED FROM THE ORIGIN OF THE RIGHT EXTERNAL ILIAC ARTERY TO ACHIEVE HEMOSTASIS. THE VESSEL DIAMETER OF THE RIGHT ACCESS VESSEL/RIGHT EXTERNAL ILIAC ARTERY AT THE NARROWEST SITE WAS REPORTED AS APPROXIMATELY 4 MM × 4.8 MM. PHYSICIAN¿S COMMENT: THE ACCESS VESSEL WAS ORIGINALLY NARROW, AND IT WAS EXPECTED THE POSSIBILITY OF VASCULAR INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 24437782 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE THORACIC AORTA USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE RIGHT SIDE, AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DEPLOYED JUST ABOVE THE CELIAC ARTERY. A NON-GORE STENT GRAFT WAS THEN IMPLANTED PROXIMALLY. AFTER ALL DEVICES WERE IMPLANTED, A DISSECTION OF THE ACCESS VESSEL, THE RIGHT EXTERNAL ILIAC ARTERY, WAS OBSERVED. A BARE STENT WAS IMPLANTED TO COVER THE DISSECTION. THE PHYSICIAN REPORTED THAT THERE WAS NO RESISTANCE DURING INSERTION OF THE SHEATH.

  Patient problems: Vascular Dissection

  MAUDE report 24399326 ↗
• InjuryJan 12, 2026Difficult to Advance; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR DESCENDING THORACIC AORTIC PSEUDOANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. AN ANGIOGRAPHY FOR ACCESS VESSELS SHOWED LOCALIZED DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY. A BARE-METAL STENT WAS PLACED TO FIX THE DISSECTION. AFTER THAT, HEMOSTASIS WITH A PERCLOSE DEVICE WAS UNSUCCESSFUL DUE TO INJURY OF THE PUNCTURE SITE, WHOSE CAUSE WAS UNKNOWN. THEREFORE, THE PUNCTURE SITE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: VASCULAR ACCESS TRAUMA WAS WITHIN EXPECTATION.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 24049943 ↗
• InjuryDec 18, 2025Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM, USING GORE DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. ANGIOGRAPHY REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY FOLLOWING STENT GRAFT DEPLOYMENT. THE MAXIMUM DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 7.9MM. AN ADDITIONAL BARE STENT WAS IMPLANTED AS TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: ¿I FELT A RESISTANCE DURING SHEATH INSERTION.¿

  Patient problems: Vascular Dissection

  MAUDE report 23836012 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) , 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A 20FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT FEMORAL ARTERY, THEN THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. AFTER THE DEVICE IMPLANTATION, A DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED. A STENT WAS IMPLANTED TO COVER THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE ILIAC ARTERY WAS SEVERELY TORTUOUS.

  Patient problems: Vascular Dissection

  MAUDE report 23785969 ↗
• InjuryNov 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE 20 FR SHEATH WAS INSERTED VIA THE RIGHT FEMORAL ARTERY. AFTER STENT GRAFT PLACEMENT, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED AN INTIMAL INJURY (FLAP) IN THE RIGHT EXTERNAL ILIAC ARTERY. A STENT WAS PLACED AS A TREATMENT. NO COMMENT WAS OBTAINED FROM THE PHYSICIAN REGARDING THE CAUSE OF THE EVENT. THE ACCESS VESSEL DIAMETER IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 23677322 ↗
• InjuryNov 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A PSEUDOANEURYSM AT THE ANASTOMOSIS SITE OF THE VASCULAR GRAFT, USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. A 20FR SHEATH WAS INSERTED FROM THE PATIENT'S RIGHT ACCESS VESSEL. AFTER PLACEMENT OF THE STENT GRAFT, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED A LOCALIZED DISSECTION IN THE RIGHT COMMON FEMORAL ARTERY. AS BLOOD FLOW TO THE LOWER LIMB WAS CONFIRMED TO BE UNAFFECTED, THE PATIENT WAS DECIDED TO BE MONITORED AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE DIAMETER OF THE NARROWED SEGMENT OF THE RIGHT ACCESS VESSEL WAS APPROXIMATELY 6.5 MM. THERE WAS NO SIGNIFICANT RESISTANCE DURING SHEATH INSERTION. THE CAUSE OF THE LOCALIZED DISSECTION REMAINS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 23565827 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. THE DSF SHEATH WAS INSERTED FROM RIGHT COMMON FEMORAL ARTERY, BUT A STRONG RESISTANCE WAS FELT, AND THE VESSEL NEAR THE INSERTION SITE WAS DAMAGED. THEREFORE, THE APPROACH SITE WAS CHANGED TO LEFT SIDE. THE DSF SHEATH WAS INSERTED FROM LEFT COMMON FEMORAL ARTERY; ALTHOUGH RESISTANCE WAS FELT, IT WAS SUCCESSFULLY ADVANCED. A DISSECTION IN THE LEFT COMMON ILIAC ARTERY WAS OBSERVED ON AN ACCESS ANGIOGRAPHY AFTER ALL DEVICES WERE PLACED. THE DISSECTION WAS TREATED BY PLACING AN ADDITIONAL STENT GRAFT. THE VESSEL DAMAGE WAS TREATED BY SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 23344505 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. AFTER PLACEMENT OF THE STENT GRAFT, MINOR BLEEDING WAS OBSERVED AT THE PUNCTURE SITE, INDICATING TISSUE DAMAGE. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED THROUGH PTA AND MANUAL COMPRESSION FROM THE CONTRALATERAL SIDE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PHYSICIAN NOTED THAT THE CAUSE WAS LIKELY EITHER IMPROPER DEPLOYMENT OF THE PERCLOSE CLOSER DEVICE OR DAMAGE INCURRED DURING SHEATH INSERTION.

  Patient problems: Perforation of Vessels

  MAUDE report 23011835 ↗
• InjuryJul 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. A VESSEL RUPTURE IN THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED ON THE ACCESS ANGIOGRAPHY. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE VESSEL RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THERE WAS NO RESISTANCE WHILE ADVANCING AND REMOVING THE SHEATH.

  Patient problems: Perforation of Vessels

  MAUDE report 22538779 ↗
• InjuryJul 16, 2025Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ENDOLEAK ASSOCIATED WITH A NON-GORE STENT GRAFT IN THE THORACIC AORTA, USING GORE TAG CONFORMABLE THORACIC STENT GRAFT, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. A 20FR SHEATH WAS INSERTED VIA THE PATIENT'S RIGHT SIDE; HOWEVER, DUE TO SEVERE CALCIFICATION, IT COULD NOT BE ADVANCED BEYOND THE RIGHT COMMON ILIAC ARTERY. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS ATTEMPTED USING TWO NON-GORE BALLOONS, BUT THE SHEATH STILL COULD NOT BE ADVANCED. SUBSEQUENTLY, THE GUIDEWIRE WAS CHANGED TO A STIFFER TYPE, AND A TRILOBE BALLOON WAS UTILIZED, WHICH ENABLED THE SHEATH TO ADVANCE WITH DIFFICULTY. AN ACCESS ANGIOGRAPHY REVEALED A DISSECTION EXTENDING FROM THE RIGHT COMMON ILIAC ARTERY TO JUST ABOVE THE AORTIC BIFURCATION. THE PHYSICIAN DECIDED TO FOLLOW UP WITH THE PATIENT AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE DISSECTION POSSIBLY OCCURRED DURING PTA OF THE RIGHT COMMON ILIAC ARTERY. I WAS EXPECTING IT TO HAPPEN AND DEEMED UNAVOIDABLE.¿

  Patient problems: Vascular Dissection

  MAUDE report 22517095 ↗
• DeathMay 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS PLANNED TO IMPLANT NON-GORE STENTGRAFTS (AFX, MAIN AND CUFF) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTA EXTENDER ENDOPROSTHESIS) TO RELINE THE JUNCTION BETWEEN THE NON-GORE STENTGRAFTS. A NON-GORE STENTGRAFT (AFX, MAIN DEVICE) WAS ATTEMPTED TO DELIVER FOLLOWING IFU, BUT IT WAS CAUGHT INSIDE THE ANEURYSM AND COULD NOT BE ADVANCED. THE SHAFT OF THE MAIN DEVICE WAS DEFORMED. THEREFORE, THIS DEVICE WAS CHANGED TO A SECOND NON-GORE STENTGRAFT (AFX, MAIN DEVICE). THE SECOND MAIN DEVICE WAS ATTEMPTED TO DELIVER, BUT IT WAS DIFFICULT. THEN, THE SECOND MAIN DEVICE WAS TRIED TO DELIVER USING A 20FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. HOWEVER, THE MAIN DEVICE WAS NOT ABLE TO BE DELIVERED OVER THE ANEURYSM. DURING THE DELIVERY, THE BLOOD PRESSURE DECREASED DUE TO AN ANEURYSM RUPTURE. A BALLOON OCCLUSION WAS PERFORMED AND A RESCUE WAS ATTEMPTED BY OPEN SURGERY, BUT IT WAS NOT SUCCESSFUL AND THE PATIENT DIED.

  Patient problems: Perforation of Vessels

  MAUDE report 21941246 ↗
• InjuryMar 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT (TEVAR, THE STENT GRAFT DETAILS UNKNOWN) FOR AN IMMINENTLY RUPTURED DESCENDING AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. ACCESS VESSEL ANGIOGRAPHY DURING THE PROCEDURE SHOWED A DISSECTION IN THE LEFT COMMON ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY. TO REPAIR THE DISSECTION, TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED FROM THE LEFT COMMON ILIAC ARTERY TO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT INTERNAL ILIAC ARTERY WAS COVERED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: THE PATIENT'S ACCESS VESSEL WAS NARROW. I THINK THAT THE VESSEL DAMAGE/DISSECTION OCCURRED DURING THE ADVANCEMENT OF THE SHEATH.

  Patient problems: Vascular Dissection

  MAUDE report 21685554 ↗
• InjuryFeb 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH TO IMPLANT A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS. FOLLOWING THE DEPLOYMENT OF THE STENT GRAFT, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED A RUPTURE IN THE LEFT EXTERNAL ILIAC ARTERY. TO REPAIR THE RUPTURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE STENT GRAFT WAS DEPLOYED AT THE SITE OF THE INJURY, SUCCESSFULLY ACHIEVING HEMOSTASIS. NO FURTHER COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN NOTED THAT THE SHEATH WAS ADVANCED SMOOTHLY WITHOUT RESISTANCE, DESPITE THE PATIENT¿S ACCESS VESSEL BEING NARROW (VESSEL SIZING INDICATED THAT THE MINIMUM DIAMETER OF THE RUPTURED LEFT EXTERNAL ILIAC ARTERY WAS 5.4 MM.). THE RUPTURE WAS SUCCESSFULLY REPAIRED USING THE VBX DEVICE, AND THE PHYSICIAN CONCLUDED THAT THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Perforation of Vessels

  MAUDE report 21312878 ↗
• InjuryNov 19, 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 AN THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). ATTEMPT WAS MADE TO INSERT A 22 FR DSF FROM RIGHT ACCESS; HOWEVER, THE 22 FR DSF WAS NOT ABLE TO BE ADVANCED. ATTEMPT WAS MADE TO ADVANCE A 20 FR DSF FOR BOUGIE; HOWEVER, IT WAS NOT ABLE TO BE ADVANCED. THE PHYSICIAN DECIDED TO SWITCH TO LEFT ACCESS. ALSO, HE DECIDED TO WITHDRAW THIS TEVAR IF THE 22 FR DSF COULD NOT BE ADVANCED. ATTEMPT WAS MADE TO INSERT THE 22 FR DSF FROM LEFT ACCESS AND IT COULD BE INSERTED AS FAR AS THE LEFT EXTERNAL ILIAC ARTERY WITH EXTRA FORCE BUT COULD NOT BE ADVANCED TO THE LEFT INTERNAL AND EXTERNAL ILIAC ARTERY BRANCH. A RUPTURE OF LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED. ADDITIONAL STENT GRAFTS WERE IMPLANTED AND THE VITAL WAS STABLE. FOR THE WITHDRAWAL OF THE TREATMENT THE 20 FR DSF WAS REMOVED FROM THE RIGHT ACCESS. THE VITAL DROPPED AND A RUPTURE OF THE RIGHT ACCESS VESSEL AROUND ACCESS AREA WAS OBSERVED. ADDITIONAL STENT GRAFTS WERE IMPLANTED. A TEARING TO DISTAL WAS CONFIRMED AND SURGICAL REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE R

  Patient problems: Perforation of Vessels

  MAUDE report 20721404 ↗
• InjuryJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRACH ENDOPROSTHESES (AORTIC COMPONENT, AORTIC EXTENDER, AND AORTIC SIDE BRANCH), GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED ALL 3 TBE DEVICES WITHOUT ANY ISSUES. AN ANGIOGRAM WAS TAKEN AFTER THE CASE. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE FSA RECEIVED A CALL FROM THE PHYSICIAN. THE PATIENT WAS HAVING DIFFICULTY MOVING THE LEFT SIDE OF THEIR BODY. THE PHYSICIAN PERFORMED A CAT SCAN AND DETERMINED THAT THE PATIENT EXPERIENCED A STROKE. THE PATIENT WAS PUT ON THE HOSPITAL¿S STROKE PROTOCOL IMMEDIATELY. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE ISSUE. THE FSA STATED THAT PRIOR TO THE PROCEDURE, THE PATIENT HAD A SPINAL DRAIN IN PLACE. THE FSA STATED THAT PRIOR TO DEVICE IMPLANTATION, THE PHYSICIAN PERFORMED A LEFT SUBCLAVIAN ARTERY TO LEFT COMMON CAROTID EXTRA-ANATOMIC BYPASS. THE BYPASS WAS PERFORMED BECAUSE THE ANEURYSM WAS LOCATED IN A PLACE THAT WOULD OF HAVE REQUIRED THE PHYSICIAN TO EXTEND OVER THE TOP OF THE LEFT C

  Patient problems: Stroke/CVA

  MAUDE report 19840608 ↗
• InjuryJul 22, 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 AORTIC DISEASE WITH TWO ULCER-LIKE PROJECTIONS (ULP) USING A 20 FR OF GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) FROM A RIGHT ACCESS. DURING THE TREATMENT, AFTER STENT GRAFT WAS IMPLANTED, A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED. FOR TREATMENT, A BARE STENT WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT SOME RESISTANCE WAS FELT DURING THE DSF INSERTION. THE DISSECTION COULD ALSO BE ATTRIBUTED TO THE OVERALL POOR VASCULAR CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 19789653 ↗
• InjuryJul 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR TREATMENT OF AN AORTIC DISSECTION RUPTURE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. THE DSF SHEATH WAS INSERTED FROM LEFT FEMORAL ARTERY. AFTER ALL DEVICES WERE IMPLANTED, RUPTURE IN LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED ON THE FINALL ACCESS ANGIOGRAPHY. THE RUPTURE WAS TREATED BY PLACING TWO STENT GRAFTS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE ACCESS VESSEL WAS POOR, VESSEL DAMAGE WAS INEVITABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 19653434 ↗

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.