GORE DRYSEAL FLEX Introducer Sheath DSF1245Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00733132628117), received between Mar 13, 2019 and Jul 3, 2026 — classified as 2 deaths, 27 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 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 PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE CONCOMITANTLY IMPLANTED AS SYSTEM COMPONENTS. ALL PLANNED DEVICES WERE SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. POSTOPERATIVELY, A SPLENIC INFARCTION WAS IDENTIFIED ON A FOLLOW-UP CT SCAN CONDUCTED BETWEEN (B)(6) 2026 (EXACT DATE UNKNOWN). ALTHOUGH THE RELATIONSHIP TO THE SPLENIC INFARCTION IS UNCLEAR, THE PATIENT COMPLAINED OF LOWER BACK PAIN. THERE WERE NO OTHER SYMPTOMS, AND NO TREATMENT WAS PROVIDED FOR THE SPLENIC INFARCTION. THE PHYSICIAN SUSPECTED THAT BLOOD CLOTS PRESENT IN THE AORTIC ARCH MAY HAVE BEEN DISLODGED DURING THE PROCEDURE, LEADING TO THE SPLENIC INFARCTION. GORE DEVICES INSERTED VIA THE AXILLARY ARTERY AND PASSING THROUGH THE AORTIC ARCH INCLUDED THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (12FR, 45 CM). IT WAS ALSO REPORTED THAT GUIDEWIRES AND CATHETERS TRAVERSING THE AORTIC ARCH C

  Patient problems: Ischemia

  MAUDE report 25701367 ↗
• InjuryMay 29, 2026Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WAS IMPLANTED TO TREAT A CHRONIC DISSECTION. THE DAY AFTER EVERYTHING LOOKED WELL. A FOLLOW-UP CT SCAN WAS PERFORMED ONE WEEK AFTER THE PROCEDURE, AND IT WAS DISCOVERED THAT THE PATIENT DEVELOPED A PROXIMAL DISSECTION RIGHT AFTER THE LEFT SUBCLAVIAN ARTERY (LSA). ACCORDING TO THE PHYSICIAN THIS CAN ONLY BE RELATED TO THE UPPER VASCULAR ACCESS MADE FOR THE INTRODUCTION OF THE TAMBE BRANCH COMPONENTS, WHERE A 12 F GORE® DRYSEAL FLEX INTRODUCER SHEATH IS USED. THIS ACCESS WAS MADE VIA THE LEFT AXILLARY ARTERY INTO THE LSA AND DOWN THE DESCENDING THORACIC AORTA. THE PATIENT HAS BEEN TREATED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND ONE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS TO CONNECT TO THE TAMBE COMPONENT.

  Patient problems: Vascular Dissection

  MAUDE report 25328269 ↗
• DeathMay 26, 2026Patient-Device Incompatibility

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2026, A PATIENT WITH PARARENAL ANEURYSM WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. A VASCULAR ACCESS VIA THE RIGHT AXILLARY ARTERY WAS MADE FOR THE INTRODUCTION OF THE TAMBE BRANCH COMPONENTS, WHERE A 12 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS USED. ON THE SAME DATE, THE PATIENT SUFFERED A TYPE A DISSECTION WITH THE PRIMARY ENTRY TEAR IN THE ASCENDING AORTA, EXTENDING INTO THE DESCENDING AORTA. IT IS NOT KNOWN IF THIS DISSECTION REACHED THE MOST PROXIMAL IMPLANTED DEVICE. A SUPRACORONARY ASCENDING AORTA REPLACEMENT (SCAR) WAS PERFORMED. INITIALLY, THE PATIENT APPEARED TO HAVE RECOVERED WELL BUT UNFORTUNATELY PASSED AWAY ON (B)(6) 2026. THE PHYSICIAN REPORTED THAT THE DSF, WHICH WAS INTRODUCED PASS THE BRACHIOCEPHALIC TRUNK, INTO THE AORTIC ARCH AND DOWN THE DESCENDING THORACIC AORTA, IS THE CAUSE OF THE TYPE A DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 25274360 ↗
• DeathMay 18, 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). BEFORE IMPLANTING TAMBE, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) WAS IMPLANTED IN THE DESCENDING AORTA, WITH APPROXIMATELY 3 CM OVERLAP ONTO A PREVIOUSLY IMPLANTED CTAG AC DEVICE (DETAILS OF THE PREVIOUS DEVICE WERE UNKNOWN). SUBSEQUENTLY, A PULL-THROUGH GUIDEWIRE WAS ESTABLISHED BY CAPTURING THE GUIDEWIRE IN THE ASCENDING AORTA AND EXTERNALIZING IT FROM THE RIGHT AXILLARY ARTERY TO THE RIGHT COMMON FEMORAL ARTERY. GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1245) WAS ADVANCED FROM THE AXILLARY ARTERY OVER THE PULL-THROUGH GUIDEWIRE. IN PREPARATION FOR SUBSEQUENT TAMBE DEPLOYMENT, GORE® TRI LUMEN CATHETER WAS USED, AND DURING ESTABLISHMENT OF THE SECOND SET OF GUIDEWIRES, THE ANESTHESIOLOGIST NOTED A DECLINE IN THE PATIENT¿S BLOOD PRESSURE. THE PATIENT¿S BLOOD PRESSURE RAPIDLY DETERIORATED, AND DESPITE IMMEDIATE CARDIOPULMONARY RESUSCITATION, SYSTOLIC BLOOD PRESSURE COULD ONLY BE MAINTAINED AT APPROXIMATELY 20¿30 MMHG. AN OCCLUS

  Patient problems: Great Vessel Perforation; Vascular Dissection

  MAUDE report 25211671 ↗
• InjuryMar 16, 2026Break; Material Integrity Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ACUTE LIMB ISCHEMIA UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) AS AN ACCESSORY. THE SHEATH WAS INSERTED VIS DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) THEN ADVANCED UP AND OVER THE TIGHT AORTIC BIFURCATION. DURING ADVANCEMENT, SOME RESISTANCE FELT BUT SHEATH ADVANCED APPROPRIATELY. THE PENUMBRA LIGHTNINGBOLT DEVICE WAS ADVANCED WHEN THE SHEATH TRANSECTED IN TWO. A SFA CUTDOWN WAS REQUIRED TO CUT THE WIRE CONNECTING THE TWO PARTS OF THE SHEATH AND FACILITATE REMOVAL. PHYSICIAN STATES ITS POSSIBLY DUE THE LACK OF A TAPERED INTRODUCER FOR THE THROMBECTOMY DEVICE, COMBINED WITH THE 4.0MM INNER DIAMETER OF THE DSF AND THE 4.04MM OD OF THE LIGHTNING BOLT 12 IN THE SETTING OF A LIKELY COMPRESSED/FOLDED DSF LUMEN (OVER THE TIGHT AORTIC BIFURCATION) AND THE STIFFNESS OF THE THROMBECTOMY DEVICE ONCE FORCED INTO A SMALL LUMEN THAT CAUSED THE SHEATH TO TRANSECT IN TWO. THERE WAS NO GORE FIELD SALES ASSOCIATE (FSA) PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611887 ↗
• InjuryFeb 11, 2026Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ACUTE LIMB ISCHEMIA UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, A GORE DRYSEAL SHEATH WAS INTRODUCED VIA A CONTRALATERAL APPROACH (LEFT GROIN ACCESS) WITH THE TIP POSITIONED IN THE RIGHT DISTAL EXTERNAL ILIAC ARTERY THEN A SUPRACORE WIRE WAS PLACED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND CAREFULLY MONITORED TO AVOID CROSSING A FRESH OCCLUSION. A PENUMBRA BOLT 12 CATHETER (PENUMBRA LIGHTNING THROMBECTOMY CATHETER) WAS THEN INSERTED. SOME MILD RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE BOLT 12 CATHETER. THIS RESISTANCE WAS CONSISTENT WITH PASSING OF A 12FR DEVICE THROUGH A 12FR SHEATH IN A CROSSOVER CONFIGURATION AND WAS NOT EXCESSIVE. FOLLOWING THE RESISTANCE, THE WIRE WAS OBSERVED "JUMPING" ON THE SCREEN. FLUOROSCOPY OF THE AORTIC BIFURCATION REVEALED THE SHEATH HAD TRANSECTED (SNAPPED IN HALF). PHYSICIAN NOTED THAT THIS FAILURE IS UNPRECEDENTED IN THEIR EXPERIENCE AS THEY WOULD HAVE EXPECTED THE SHEATH TO PROLAPSE INTO THE AORTA UNDER TENSION RATHER THAN SNAPPING. THE TIP OF THE PENUMBRA CATHETER REMAINED INTACT AND WAS SUC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24312885 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 62-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA TRUNK IPSILATERAL LEG ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® BRANCH ENDOPROSTHESIS DEVICES. THERE WAS SUCCESSFUL ACCESS, DELIVERY AND ACCURATE DEPLOYMENT OF THE DEVICES TO THE INTENDED LOCATION AND SUCCESSFUL RETRIEVAL OF THE DELIVERY SYSTEMS. IT WAS REPORTED THAT THE PATIENT HAD A BLEEDING AT THE LEFT FEMORAL ARTERY ACCESS SITE RELATED TO TREATMENT/PROCEDURE. THIS LED TO TRANSFUSION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23814360 ↗
• InjuryNov 30, 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, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON THE SAME DAY AFTER THE PROCEDURE, THE PATIENT SHOWED DELAYED RECOVERY FROM GENERAL ANESTHESIA AND SUBSEQUENTLY DEVELOPED SYMPTOMS SUCH AS FATIGUE AND DIFFICULTY SPEAKING. CEREBRAL INFARCTION WAS CONFIRMED. AT THE TIME OF THIS REPORTING, REHABILITATION WAS ONGOING, AND THE PATIENT¿S CONDITION HAD IMPROVED; HOWEVER, HE WAS STILL HOSPITALIZED. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: SINCE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WAS PERFORMED THREE DAYS PRIOR TO THIS PROCEDURE (ON (B)(6) 2025), IT IS UNCLEAR WHETHER THIS EVENT WAS CAUSED BY THE TAMBE PROCEDURE. HOWEVER, AS A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE RIGHT AXILLARY ARTERY OVER THE ORIGINS OF THE RIGHT VERTEBRAL ARTERY AND COMMON CAROTID ARTERY, AND COMPLEX DEVICE MANIPULATION WAS PERFORMED DURING THE PROCEDURE, IT IS POSSIBLE THAT THE SHEATH CONTRIBUTED TO THE ONSET OF CEREBRAL INFARCTION.

  Patient problems: Ischemia Stroke

  MAUDE report 23677419 ↗
• InjuryJul 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, FROM THE MEDRIO STUDY DATABASE: ON (B)(6) 2022, THIS 76-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR A PARARENAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH MULTIPLE GORE® DEVICES INCLUDING THREE GORE®DRYSEAL FLEX INTRODUCER SHEATH DEVICES. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE LEFT AND RIGHT FEMORAL ARTERIES AND BY CUT DOWN ON THE LEFT ARM. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE A RIGHT FEMORAL PSEUDOANEURYSM. THE ADVERSE EVENT WAS RELATED TO VASCULAR ACCESS RELATED TO THE FEMORAL ARTERY. TREATMENT WAS NOT REQUIRED FOR THIS ADVERSE EVENT. THE OUTCOME OF THIS ADVERSE EVENT IS NOTED TO BE ONGOING.

  Patient problems: Pseudoaneurysm

  MAUDE report 22512835 ↗
• InjuryFeb 26, 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, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE TREATMENT, A 12 FR DSF WAS USED FROM THE RIGHT ACCESS. WHEN A GEKIRA BALLOON WAS INSERTED TO TOUCH-UP, A GUIDEWIRE SLIPPED OUT OF THE LEFT INTERNAL ILIAC ARTERY, COMPLICATING THE PROCEDURE. ADDITIONALLY, WHEN ATTEMPTING TO INSERT THE GEKIRA BALLOON AGAIN, RESISTANCE WAS FELT AND IT WAS DIFFICULT TO ADVANCE THE GEKIRA BALLOON TO THE LEFT INTERNAL ILIAC ARTERY. FINALLY, TOUCH-UP OF THE DISTAL SIDE OF THE LEFT INTERNAL ILIAC ARTERY WAS ABANDONED. THE 12 FR DSF WAS SWITCHED TO AN 18 FR DSF TO IMPLANT A TRUNK-IPSILATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6)2025, THE PATIENT PRESENTED WITH RIGHT LEG PAIN AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED AN OCCLUSION BELOW THE RIGHT KNEE. EMERGENCY THROMBECTOMY WAS PERFORMED AND BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THAT NOT SURE THE OCCLUSION WAS RELATED TO THE EVAR.

  Patient problems: Embolism/Embolus

  MAUDE report 21466802 ↗
• InjuryOct 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR BILATERAL INTERNAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS. THE 12 FR SHEATH WAS INSERTED FROM THE LEFT SIDE OF THE PATIENT AND ADVANCED TO THE CONTRALATERAL/RIGHT SIDE. THE INSERTION WAS DIFFICULT, SO TWO GUIDEWIRES WERE INSERTED INTO THE DILATOR FOR ADVANCEMENT. FINAL ANGIOGRAPHY AFTER STENT GRAFT PLACEMENT CONFIRMED A DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY. NO TREATMENT WAS PERFORMED, AND THE PATIENT WAS DECIDED TO BE MONITORED. THE PHYSICIAN MENTIONED THAT THE DISSECTION WAS FORMED DUE TO EXCESSIVE FORCE APPLIED WHEN ADVANCING THE 12F SHEATH ON CROSS OVER FROM THE LEFT SIDE. TWO 12 FR SHEATH WERE USED IN THIS PROCEDURE, BUT IT WAS UNKNOWN WHICH ONE WAS INSERTED FROM THE LEFT SIDE.

  Patient problems: Vascular Dissection

  MAUDE report 20349609 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH ENDURANT¿ DEVICES FOR ABDOMINAL AORTIC ANEURYSM. THEREAFTER, THE LEFT COMMON ILIAC ARTERY (CIA) WAS ENLARGED AND THE LEFT INTERNAL ILIAC ARTERY ANEURYSM (IIAA) WAS ENLARGED. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THE LEFT CIA ENLARGEMENT AND THE LEFT IIAA USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE "UP & OVER" TECHNIQUE WAS USED; A DSF1245 WAS INSERTED FROM THE RIGHT SIDE AND ADVANCED OVER THE FLOW DIVIDER OF THE PREVIOUSLY IMPLANTED ENDURANT¿ TO THE LEFT SIDE TREATMENT SITE. THE STENT GRAFTS WERE IMPLANTED, AND AFTER HAEMOSTASIS WITH THE PRECLOSE TECHNIQUE, DECREASED BLOOD FLOW IN THE RIGHT LOWER LIMB WAS OBSERVED. ULTRASOUND CONFIRMED A SUSPECTED BELOW-KNEE EMBOLISM, SO ABOVE THE KNEE (LATERAL TO THE KNEE) WAS CUT DOWN AND THROMBECTOMY USING A FOGARTY CATHETER WAS PERFORMED. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING IMPROVED BLOOD FLOW. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: THE MOST RECENT CT BEFORE THE PROCEDURE SHOWED AN INCREASE IN THROMBUS INSIDE OF THE IMPLANTED ENDURANT¿. THE THROMBUS DISPERSAL WAS MOST LIKELY CAUSED BY MANIPULATIONS SUCH

  Patient problems: Embolism/Embolus

  MAUDE report 19747183 ↗
• InjuryJun 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THE LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® DRYSEAL FLEX INTRODUCER SHEATHS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). THE PATIENT HAD UNDERGONE A Y-GRAFT REPLACEMENT IN THE ABDOMINAL AORTA ABOUT 20 YEARS AGO. A 12 FR SHEATH WAS INSERTED FROM THE RIGHT SIDE/CONTRALATERAL SIDE TO THE LEFT SIDE BY CROSS-OVER APPROACH. AN ILIAC BRANCH COMPONENT WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY AND TWO VBX WERE PLACED AND LANDED ITS DISTAL SIDE IN THE LEFT INTERNAL ILIAC ARTERY. ON THE FINAL ANGIOGRAPHY, A LOCALIZED DISSECTION WAS OBSERVED IN THE AORTA NEAR THE PROXIMAL ANASTOMOSIS OF THE Y-GRAFT. THE PATIENT WAS DECIDED TO BE MONITORED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN'S COMMENT: THE LOCALIZED DISSECTION OF THE AORTA MAY HAVE FORMED AT EITHER TIME WHEN THE 12 FR SHEATH BOUNCING DURING THE INITIAL INSERTION BEFORE OVER-OVER OR DURING REMOVAL AFTER STENT GRAFT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 19555549 ↗
• InjuryJun 13, 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 ABDOMINAL AORTIC ANEURYSM AND AN ILIAC ARTERY ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE TREATMENT, THE LEFT COMMON ILIAC ARTERY WAS HIGHLY TORTUOUS AND A RADIFOCUS GUIDEWIRE WAS DIFFICULT TO ADVANCED. TWO DSF DEVICES WERE USED IN THE LEFT LEG. BEFORE INSERTING A CONTRALATERAL LEG INTO THE LEFT LEG, AN ANGIOGRAPHY USING THE DSF REVEALED A DISSECTION IN THE LEFT COMMON ILIAC ARTERY. A CONTRALATERAL LEG WAS IMPLANTED AS PLANNED AND THE DISSECTION WAS COVERED. AFTER ALL DEVICES WERE IMPLANTED, A FINAL ANGIOGRAPHY WAS PERFORMED. THE DISSECTION APPEARED TO EXTEND TO THE LEFT INTERNAL ILIAC ARTERY. BLOOD FLOW INTO THE LEFT INTERNAL ILIAC ARTERY WAS NO ISSUE. THE PHYSICIAN DECIDED TO MONITOR IT.

  Patient problems: Vascular Dissection

  MAUDE report 19526323 ↗
• MalfunctionMar 11, 2024Break; Break

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. WHILE INSERTING THE 12FR SHEATH, IT WAS STUCK NEAR THE PUNCTURE SITE AND COULD NOT BE ADVANCED. THE TIP OF THE DEVICE SEEMED TO BE SQUISHED. THE PROCEDURE WAS CONTINUED WITH AN ALTERNATIVE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: ¿THE PATIENT HAD QUITE TOUGH SKIN. THE DEVICE MAY HAVE BEEN STUCK WHEN I TRIED TO INSERT IT INTO IT. ¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18872628 ↗
• MalfunctionJan 26, 2024Fracture; Fracture

  FSA REPORTED THE FOLLOWING: ON (B)(6) 2023, PATIENT UNDERWENT A PROCEDURE UTILIZING A GORE® DRY SEAL FLEX INTRODUCER SHEATH TO TREAT A COLD LEG (NO GORE REPRESENTATIVE WAS PRESENT AT THIS CASE). DURING THE PROCEDURE, AS PHYSICIAN WAS GOING UP AND OVER AORTIC BIFURCATION, THE SHEATH BROKE IN HALF. PHYSICIAN THEN INFLATED A BALLOON IN THE PART OF THE SHEATH THAT SEPARATED, AND WAS ABLE TO PULL IT OUT. PROCEDURE WAS FINALIZED USING ANOTHER SHEATH. NO FURTHER ISSUES WERE NOTED. PHYSICIAN ATTRIBUTES THIS SHEATH ISSUE DUE TO PATIENT ANATOMY AS THERE WAS CALCIFICATION. PATIENT TOLERATED THE PROCEDURE. DEVICE WAS DISCARDED AND NO IMAGES ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18590637 ↗
• InjuryOct 3, 2023Unintended Collision; Unintended Collision

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (EXCC), GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). INSTEAD OF INTERNAL ILIAC COMPONENT OF IBE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS USED. WHEN DELIVERING THE VBX, A GUIDEWIRE FELL OUT FROM THE INTERNAL ILIAC ARTERY, THEREFORE, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE VBX ONCE TO ADVANCE THE GUIDEWIRE AGAIN. THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT, BUT THE PHYSICIAN NOTICED THAT THE CONSTRAINED STENT GRAFT WAS DISLODGED INSIDE THE PATIENT. IT WAS FOUND IN THE TRUNK OF EXCC. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE DISLODGED STENT GRAFT BY A SNARE CATHETER; HOWEVER, THE ATTEMPT FAILED. IN ADDITION, THE SNARE CATHETER CAUSED DAMAGE ON THE VALVE OF GORE® DRYSEAL FLEX INTRODUCER SHEATH, RESULTING IN MASSIVE BLEEDING (APPROXIMATELY 1 L) FROM THE VALVE AND THE PATIENT FELL INTO SHOCK VITALS. THE DAMAGED SHEATH WAS REMOVED AND ANOTHER ONE WAS INSERTED. AN OCCLUSION BALLOON WAS INFL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock

  MAUDE report 17865217 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH TO TREAT THE RIGHT COMMON ILIAC ARTERY ANEURYSM AND THE LEFT COMMON ILIAC ARTERY ANEURYSM THAT WAS SUSPECTED BUT NOT DETERMINED, PREOPERATIVELY, IF THE LEFT ANEURYSM SHOULD ALSO BE TREATED AT THE SAME TIME. THE PATIENT HAD PREVIOUSLY UNDERGONE AN ABDOMINAL AORTIC GRAFT REPLACEMENT USING J GRAFT (JAPAN LIFELINE CO., LTD) ON (B)(6), 2016. DURING THE PROCEDURE, A SHEATH WAS DELIVERED FROM PATIENT¿S RIGHT LIMB AND A PULL-THROUGH WIRE WAS FORMED. AN ILIAC BRANCH COMPONENT (IBC, CEB231210A/26688492) WAS THEN DELIVERED FROM THE RIGHT LIMB, AND ITS PROXIMAL PORTION WAS DEPLOYED AT THE RIGHT COMMON ILIAC ARTERY. THE PROXIMAL END OF THE IBC WAS PLACED WITHIN THE J GRAFT. A 12FR 45CM SHEATH WAS THEN DELIVERED FROM PATIENT¿S LEFT LIMB, HOWEVER, THE SHEATH ADVANCEMENT WAS REPORTEDLY DIFFICULT BECAUSE IT WAS DELIVERED WITHIN THE J GRAFT, NOT THE NATIVE VESSEL. BECAUSE OF THE J GRAFT, THE VESSEL WALL WAS LESS SMOOTH THAN THE NATIVE VESSEL AND THE SHEATH WAS MORE PRON

  Patient problems: Aneurysm

  MAUDE report 17685914 ↗
• MalfunctionAug 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), GORE® EXCLUDER® AAA ENDOPROSTHESES, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. A 12 FR DSF WAS USED WITH A PULL-THOUGH WIRE TECHNIQUE. AFTER STENT GRAFTS WERE IMPLANTED, A 3D COMPUTED TOMOGRAPHY REVEALED A PART OF A IPSILATERAL LEG AS A LEFT LEG WAS SLIGHTLY NARROW. THE NARROW PART OF THE IPSILATERAL LEG WAS PUSHED BY A RIGHT LEG AT A NARROW AORTA AREA. TO TREAT IT, ADDITIONAL BARE STENT WAS IMPLANTED INTO THE IPSILATERAL LEG AND IT WAS RESOLVED. WHEN REMOVED THE 12 FR DSF, A TEAR IN A TIP OF A SHEATH WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THERE WAS THE TEAR IN THE TIP OF THE SHEATH. IT WAS RARE FOR THIS TO HAPPEN WITH THE DSF.

  Patient problems: Aneurysm

  MAUDE report 17602936 ↗
• InjuryAug 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS), FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRALATERAL LEG ENDOPROSTHESES), TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (ILIAC BRANCH COMPONENT AND INTERNAL ILIAC COMPONENT). BEFORE ENDOPROSTHESES WERE IMPLANTED, THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AS PLANNED. A 18FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT) WAS DELIVERED. THEN, THE PROXIMAL OF THE ILIAC BRANCH COMPONENT WAS DEPLOYED. A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1245) WAS INSERTED FROM THE RIGHT SIDE AND THE CANNULATION TO THE LEFT INTERNAL ILIAC ARTERY WAS SUCCESS. BALLOONING WAS PERFORMED TO THE ORIGIN OF THE LEFT INTERNAL ILIAC ARTERY BECAUSE IT WAS NARROW. THEN, THE INTERNAL ILIAC COMPONENT WAS DEPLOYED. THE EXTERNAL ILIAC LEG OF THE ILIAC BRANCH COMPONENT WAS ALSO DEPLOYED. AFTERWARDS, THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) WAS DELIVERED AND PROXIMA

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487959 ↗
• InjuryDec 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THIS PATIENT UNDERWENT A REINTERVENTION FOR A PREVIOUSLY IMPLANTED ENDURANT DEVICE USING GORE® EXCLUDER® AAA ENDOPROSTHESES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, AN ANGIOGRAPHY FOR THE RIGHT ACCESS SITE SHOWED A DISSECTION IN THE EXTERNAL ILIAC ARTERY AFTER ALL THE PLANNED DEVICES WERE SUCCESSFULLY PLACED. A BARE-METAL STENT (EPIC VASCULAR STENT, 10 MM X 60 MM) WAS ADDITIONALLY IMPLANTED IN THE DISSECTED SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE SHEATH WAS FORCIBLY ADVANCED OVER THE PULL-THROUGH GUIDEWIRE. CONSIDERING THE PREVIOUSLY IMPLANTED DEVICE, ADEQUATE TENSION COULD NOT BE APPLIED TO THE PULL-THROUGH GUIDEWIRE.

  Patient problems: Vascular Dissection

  MAUDE report 16000129 ↗
• MalfunctionNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, DURING AN ENDOVASCULAR PROCEDURE IT WAS REPORTED THAT THE TIP OF THE DILATOR OF A GORE® DRYSEAL FLEX INTRODUCER SHEATH KIND OF SHEARED OFF DUE TO WIRE WRAP; THE PHYSICIAN PUSHED THE DILATOR INTO THE WIRE WRAP, BUT IT STILL SHEARED OFF. THE PATIENT TOLERATED THE PROCEDURE. THE DILATOR WILL BE RETURNED TO GORE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797759 ↗
• InjuryJul 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (SHEATH). DURING TREATMENT, A 12FR SHEATH WAS INSERTED FROM A RIGHT-SIDED ACCESS SITE, THEN ADVANCED OVER THE AORTIC BIFURCATION TO THE LEFT SIDE TO IMPLANT IBE DEVICES. ACCORDING TO THE REPORT, THE PHYSICIAN STATED THAT HE FELT "RUBBING" AGAINST THE VESSEL WALL WHEN INSERTING THE SHEATH. AFTER ALL GORE® EXCLUDER® DEVICES WERE IMPLANTED, AN INTRA-OPERATIVE ANGIOGRAPH REPORTEDLY REVEALED A MINOR TYPE II ENDOLEAK. ACCESS ANGIOGRAPHY ALSO REPORTEDLY REVEALED A POOLING OF CONTRAST IN THE RIGHT EXTERNAL ILIAC ARTERY DISTAL TO THE IPSILATERAL LIMB. THE POOLING OF CONTRAST WAS THOUGHT TO BE A DISSECTION OR PSEUDOANEURYSM FORMATION. TO TREAT THE POSSIBLE VESSEL INJURY, AN ADDITIONAL STENT GRAFT WAS IMPLANTED DISTALLY. THE ISSUE WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DID NOT COMMENT ON THE POTENTIAL CAUSE OF THE ACCESS VESSEL TRAUMA. IT WAS REPORTED THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 7.1MM TO 8.1MM IN DIAMETER IN THE REGION

  Patient problems: Vascular Dissection

  MAUDE report 15089873 ↗
• 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) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® CONTRALATERAL LEG ENDOPROSTHESES, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES 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) 2020, THE PATIENT HAD AN INCISION INFECTION. REPORTEDLY, THE PATIENT CAME IN FOR AN OFFICE VISIT DUE TO LEFT BRACHIAL INCISION REDNESS AND TENDERNESS. INCISION SITE WAS ASSESSED, AND WOUND CARE PERFORMED. PATIENT PRESCRIBED ANTIBIOTICS AND GIVEN WOUND CARE INSTRUCTIONS. THE INFECTION WAS RESOLVED ON (B)(6) 2020.

  Patient problems: Aneurysm

  MAUDE report 14795369 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM WITH BILATERAL ILIAC ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A SHORT TIME AFTER THE SURGERY, NO PULSE COULD BE FELT IN THE PATIENT'S LEFT FOOT. ANGIOGRAPHY SHOWED THROMBUS OCCLUSION BELOW THE LEFT POPLITEAL ARTERY (ANTERIOR TIBIAL ARTERY, POSTERIOR TIBIAL ARTERY, AND PERONEAL ARTERY). THEREFORE, A THROMBECTOMY WAS PERFORMED AND BLOOD FLOW WAS IMPROVED. THE PHYSICIAN COMMENTED THAT THE THROMBUS OCCLUSION WAS POSSIBLY CAUSED BY INTRAOPERATIVE GUIDEWIRE MANIPULATION. IT WAS REPORTED THAT THE CAUSAL RELATION WITH 18FR GORE® DRYSEAL SHEATH WAS NOT RULED OUT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14111941 ↗

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.