GORE DRYSEAL FLEX Introducer Sheath DSF1233Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00733132629961), received between Jul 10, 2018 and Jul 31, 2026 — classified as 1 death, 82 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (25 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 92 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Patient Device Interaction Problem

  The following was reported to Gore:On (b)(6) 2026, the patient underwent endovascular treatment for left common iliac artery enlargement after implantation of a non-Gore stent graft (Endurant). A GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface and GORE® EXCLUDER® AAA Endoprosthesis devices (iliac extender endoprosthesis and contralateral leg endoprosthesis) were planned to be implanted to extend the non-Gore stent graft to the left external iliac artery.While a 12Fr GORE® Dry Seal Flex Introducer Sheath was being advanced for stent graft implantation, the access vessel ruptured, resulting in bleeding. Temporary hemostasis was achieved, and the procedure was continued.After all devices had been implanted, the left common femoral artery was repaired surgically. Final angiography revealed no evidence of contrast extravasation from the access vessel injury, and blood flow was maintained. The procedure was then concluded.It was reported that there was severe tortuosity in the left external iliac artery and severe calcification in the left common femoral artery.The physician stated that the access vessel rupture occurred when the 12Fr sheath passed through the severely tortu

  Patient problems: Perforation of Vessels

  MAUDE report 50096089 ↗
• MalfunctionJun 19, 2026Break; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, AN 82-YEAR-OLD FEMALE PATIENT UNDERWENT A RIGHT FEMORAL ARTERY THROMBOASPIRATION PROCEDURE DURING WHICH A GORE® DRYSEAL FLEX INTRODUCER SHEATH (1233) REPORTEDLY BROKE AT THE LEVEL OF THE LEFT FEMORAL ARTERY. REPORTEDLY, THE BROKEN DEVICE FRAGMENT SUBSEQUENTLY MIGRATED INTO THE LEFT FEMORAL ARTERY, WHERE IT WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE EVENT REPORTEDLY RESULTED IN PROLONGED PROCEDURE TIME AND A POSSIBLE RISK OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565925 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A LEFT INTERNAL ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT). AFTER THE INTERNAL ILIAC COMPONENT WAS IMPLANTED, FINAL ANGIOGRAPHY REVEALED A DISSECTION IN THE LEFT COMMON ILIAC ARTERY. THIS DISSECTION OCCURRED WHEN A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS ADVANCED. THE PHYSICIAN DECIDED TO MONITOR THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 25312760 ↗
• InjuryMay 14, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE LEFT EXTERNAL ILIAC ARTERY WAS HIGHLY ANGULATED AND ADVANCEMENT OF A GUIDEWIRE WAS EXTREMELY DIFFICULT DUE TO STRONG RESISTANCE. THE EGOIST ULTIMATE GUIDEWIRE COULD NOT STRAIGHTEN THE ARTERY, BUT THE SHEATH WAS SUCCESSFULLY ADVANCED TO THE TARGET REGION. ALL THE PLANNED DEVICES WERE IMPLANTED WITHOUT PROBLEMS. DURING CLOSURE OF THE SURGICAL WOUND, PULSE OF THE LEFT LOWER LIMB WAS UNPALPABLE. AN ANGIOGRAPHY SHOWED VASCULAR DISSECTION ON THE LEFT EXTERNAL ILIAC ARTERY. AN ADDITIONAL BARE-METAL STENT WAS PLACED TO FIX THE DISSECTION. THE BLOOD FLOW IMPROVED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ACCESS TO THE LEFT SIDE WAS MORE DIFFICULT THAN EXPECTED. THE VASCULAR DISSECTION PROBABLY OCCURRED DURING INSERTION OF THE DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 25170351 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, A GORE® MOLDING & OCCLUSION BALLOON CATHETER, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH DEVICES. A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE, AND A TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS IMPLANTED. SUBSEQUENTLY, A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE, AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED. THE IPSILATERAL LEG WAS THEN DEPLOYED. A TOUCH-UP WAS PERFORMED USING THE GORE® MOLDING & OCCLUSION BALLOON CATHETER. AFTER ALL DEVICES WERE IMPLANTED, ANGIOGRAPHY REVEALED NO ENDOLEAKS. THE PRESSURE WAVEFORM WAS UNSTABLE, AND PERIPHERAL ANGIOGRAPHY REVEALED POOR FLOW ABOVE THE KNEE. A CUTDOWN WAS PERFORMED, AND THROMBI WERE REMOVED USING A FOGARTY CATHETER. THE PRESSURE WAVEFORM BECAME STABLE, AND THE PROCEDURE WAS CONCLUDED. THE PHYSICIAN SUGGESTED THAT THROMBI MAY HAVE BEEN SCATTERED DUE TO GUIDEWIRE MANIPULATION.

  Patient problems: Embolism/Embolus

  MAUDE report 25107956 ↗
• InjuryApr 22, 2026Patient Device Interaction Problem

  ON (B)(6), 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. WHILE ADVANCING THE SHEATH, IT BECAME NOT ADVANCE AFTER PASSING THE FIRST TORTUOUS OF THE RIGHT EXTERNAL ILIAC ARTERY. DURING ATTEMPTS TO ADVANCE THE SHEATH, THE BLOOD PRESSURE DECREASED TO THE 20S. A RUPTURE OF THE RIGHT COMMON ILIAC ARTERY OR VESSEL INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY WAS SUSPECTED. THE PROCEDURE WAS SUBSEQUENTLY CONVERTED TO GRAFT REPLACEMENT SURGERY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE RIGHT EXTERNAL ILIAC ARTERY WAS HIGHLY TORTUOSITY.

  Patient problems: Perforation of Vessels

  MAUDE report 24949110 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE EXCLUDER AAA ENDOPROSTHESES, ALONG WITH THE GORE MOLDING & OCCLUSION BALLOON CATHETER AND THE GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. IT WAS FURTHER REPORTED THAT TWO SHEATHS - A 12 FR SHEATH AND AN ANEURYSM COIL SHEATH - WERE INSERTED SIMULTANEOUSLY VIA THE LEFT COMMON FEMORAL ARTERY. AFTER DEPLOYMENT OF THE STENT GRAFTS, BALLOON DILATION WITH A MOB BALLOON WAS PERFORMED ON THE LEFT LIMB (PLC141000J). SUBSEQUENT ANGIOGRAPHY REVEALED A SUSPECTED DISSECTION OF THE LEFT COMMON ILIAC ARTERY, AS WELL AS DECREASED BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY. AN ADDITIONAL STENT GRAFT WAS PLACED TO EXTEND THE LEFT LIMB AS PART OF THE TREATMENT. ALTHOUGH BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY REMAINED REDUCED, THE PROCEDURE WAS COMPLETED WITH THE PATIENT PLACED UNDER OBSERVATION.

  Patient problems: Vascular Dissection

  MAUDE report 24787842 ↗
• InjuryMar 3, 2026Difficult to Advance; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR RIGHT COMMON ILIAC ARTERY RUPTURE USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). REPORTEDLY, DIAMETER OF THE BILATERAL EXTERNAL ILIAC ARTERY RANGED 3 TO 6 MM, AND ON BOTH SIDES, THERE WAS RESISTANCE DURING ADVANCEMENT OF THE DSF SHEATHS. THE PHYSICIAN FORCIBLY INSERTED THE DSF SHEATHS. FOLLOWING THE INSERTION OF DSF SHEATH, BLOOD PRESSURE DROPPED AND RUPTURE OF THE RIGHT ACCESS VESSEL WAS CONFIRMED. AFTER DEPLOYMENT OF THE PLANNED DEVICES, GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS ADDITIONALLY IMPLANTED ON THE RIGHT EXTERNAL ILIAC ARTERY; HOWEVER, BLEEDING DID NOT STOP. THEREFORE, A CUT-DOWN WAS MADE AND RUPTURE OF THE PUNCTURE SITE WAS CONFIRMED. THE RIGHT ACCESS VESSEL WAS SURGICALLY REPAIRED. THE LEFT SIDE ALSO HAD A RUPTURE, SO IT WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ACCESS VESSELS WERE NARROW AND THERE WAS SEVERE CALCIFICATION. ACCESS VASCULAR RUPTURE COULD NOT BE

  Patient problems: Perforation of Vessels

  MAUDE report 24493261 ↗
• MalfunctionJan 18, 2026Fluid/Blood Leak; Material Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER PLACEMENT OF THE ILIAC BRANCH COMPONENT(IBC) ON THE LEFT SIDE, A 12 FR SHEATH WAS INSERTED FROM THE PATIENT¿S RIGHT SIDE AND ADVANCED OVER THE AORTIC BIFURCATION TO PROXIMAL TO THE LEFT INTERNAL ILIAC GATE OF THE IBC. WHEN ATTEMPTING TO SECURE THE SHEATH, IT WAS CONFIRMED THAT THE MULTILAYER TUBING OF THE SHEATH¿S SALINE INFUSION/VALVE PORT HAD BEEN SEPARATED, RESULTING IN BLOOD LEAKAGE. THE SHEATH WAS REPLACED WITH ANOTHER ONE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE FSA REPORTED THAT INTERFERENCE WITH INSTRUMENTS SUCH AS FORCEPS MAY HAVE BEEN A POSSIBLE CAUSE OF THE PORT TUBE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106773 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL VESSELS. REPORTEDLY, THE 12FR GORE SHEATH WAS ADVANCED FROM THE RIGHT-SIDE BRACHIOCEPHALIC ACCESS AND SUTURED INTO PLACE ALONG WITH OTHER WIRES PER PROCEDURE STEPS. THE ANGIOGRAPHIC RESULT WAS SUCCESSFUL AND PROCEDURE COMPLETED WITHOUT ADVERSE EVENTS. HOWEVER, IT WAS NOTED THAT THE SHEATH HAD KINKED WITH NO BLOOD LOSS AS THE ISSUE WAS WITH THE SHEATH TUBE RATHER THAN THE SHEATH VALVE. AS REPORTED, THE EXACT TIME OR CAUSE OF THE SHEATH KINK WAS NOT NOTED AT THE TIME. THE SURGEONS WERE EXPERIENCING CONSIDERABLE DIFFICULTY PASSING EVEN A 5FR CATHETER. THE TAMBE DEVICE AND ALL FOUR 0.18 WIRES WERE IN PLACE AT THIS TIME AND THE TAMBE DEVICE HAD BEEN PARTIALLY DEPLOYED, SO IT WAS NOT POSSIBLE TO REMOVE AND REPLACE THE 12FR SHEATH WITHOUT LOSING ALL ACCESS. IT WAS REPORTED THAT THE DEVICES, INCLUDING THE VBX DEVICES WERE ADVANCED THROUGH THE SHEATH WITH SOME DIFFICULTY, BUT THEY ALL REACHED THE TREATMENT SITES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087699 ↗
• InjuryNov 14, 2025Break; Difficult to Advance; Patient Device Interaction Problem; Break; Difficult to Advance; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE INSERTION OF A 12 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) ON THE RIGHT SIDE, A SLIGHT RESISTANCE WAS FELT AT THE ANGULATED PART OF THE EXTERNAL ILIAC ARTERY (EIA), BUT ADVANCEMENT WAS STILL POSSIBLE. AFTER PLACEMENT OF ALL THE PLANNED DEVICES, ANGIOGRAPHY FOR THE ACCESS VESSELS WAS PERFORMED. THE LEFT SIDE SHOWED NO ISSUES; HOWEVER, ON THE RIGHT SIDE, THE DSF SHEATH WAS UNINTENTIONALLY SLIPPED OUT OF THE PATIENT, AND THE PROCEDURE WAS INTERRUPTED. FOLLOWING REMOVAL OF THE DSF SHEATH ALONG WITH THE GUIDEWIRE, THE PATIENT¿S BLOOD PRESSURE DROPPED SUDDENLY TO THE 40-MMHG RANGE. ANGIOGRAPHY FROM THE CONTRALATERAL SIDE REVEALED VASCULAR INJURY (RUPTURE) OF THE RIGHT EIA. ALTHOUGH THE DSF SHEATH WAS REINSERTED, THE PHYSICIAN NOTED AN ABNORMAL SENSATION AT THE TIP OF THE SHEATH AND DISCONTINUED ITS USE. A NEW 12 FR DSF SHEATH WAS THEN USED. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS PLACED AT THE INJURED SITE AND THE BLEEDING WAS STOPPED. THE PATIENT TOLERATED

  Patient problems: Perforation of Vessels

  MAUDE report 23551432 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS ACCESSORY. DURING USE OF THE SHEATH, BLOOD LEAKAGE WAS OBSERVED FROM THE SHEATH VALVE. AS THE VALVE WAS NOT FUNCTIONING PROPERLY, CONTINUED USE WAS DEEMED DIFFICULT. THE SHEATH WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483276 ↗
• InjuryOct 29, 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 FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, THE VALVE OF THE DESF WAS DAMAGED BY FORCEPS, RESULTING IN BLEEDING. THE DEVICE WAS REPLACED WITH AN ALTERNATIVE, AND THE PROCEDURE WAS CONTINUED. A BLOOD TRANSFUSION WAS ALSO PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23411224 ↗
• InjuryJul 31, 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 ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON THE RIGHT SIDE, THE CONTRALATERAL LEG ENDOPROSTHESIS WAS DEPLOYED WHILE PUSHING UP, BUT THE RIGHT INTERNAL ILIAC ARTERY (IIA) WAS UNINTENTIONALLY COVERED. SUBSEQUENTLY, ON THE LEFT SIDE, THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED IN A SIMILAR MANNER, RESULTING IN UNINTENTIONAL COVERAGE OF THE LEFT IIA AS WELL. TO RESTORE BLOOD FLOW TO THE RIGHT IIA, REPOSITIONING OF THE STENT GRAFT WAS PERFORMED USING A NON-GORE BALLOON CATHETER AND THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. AS A RESULT OF THIS ADJUSTMENT, A DISSECTION WAS OBSERVED IN THE RIGHT EXTERNAL ILIAC ARTERY. A BARE METAL STENT WAS DEPLOYED TO TREAT THE DISSECTION. BALLOONING WAS PERFORMED TO RESTORE BLOOD FLOW TO THE LEFT IIA. FINAL ANGIOGRAPHY CONFIRMED OCCLUSION OF THE RIGHT IIA AND REDUCED PERFUSION TO THE LEFT IIA. THE PHYSICIAN SUGGESTED THE POSSIBILITY OF THROMBUS MIGRATION.

  Patient problems: Vascular Dissection

  MAUDE report 22672874 ↗
• InjuryJul 6, 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 AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED AS AN ACCESSORY. AFTER ALL STENT GRAFTS WERE IMPLANTED, A MINOR PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE ENDOLEAK WAS DECIDED TO BE MONITORED. AT THE TIME OF WOUND CLOSURE, A THROMBUS WAS IDENTIFIED IN THE LEFT EXTERNAL ILIAC ARTERY, AND ACCESS ANGIOGRAPHY WAS PERFORMED, REVEALING A DISSECTION IN THE SAME ARTERY. THE PROCEDURE WAS COMPLETED BY PLACING A STENT IN THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN NOTED THAT THE PATIENT'S COMMON ILIAC ARTERY WAS TORTUOUS, AND THE DISSECTION MAY HAVE OCCURRED DURING SHEATH INSERTION.

  Patient problems: Vascular Dissection

  MAUDE report 22409009 ↗
• InjuryJul 1, 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 ABDOMINAL AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER DEPLOYMENT OF ALL STENT GRAFTS, ABSENCE OF A PALPABLE PULSE IN THE RIGHT LOWER LIMB WAS NOTED DURING WOUND CLOSURE. ANGIOGRAPHY REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. TO TREAT THE DISSECTION, A BARE STENT WAS DEPLOYED. A SUBSEQUENT ANGIOGRAPHY CONFIRMED THAT THE DISSECTION EXTENDED TO THE DEVICE INSERTION SITE, PROMPTING SURGICAL TREATMENT.

  Patient problems: Vascular Dissection

  MAUDE report 22379398 ↗
• InjuryJun 17, 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 ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESES, AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. AFTER POSTOPERATIVE HEMOSTASIS, DIMINISHED PALPATION OF THE LEFT DORSALIS PEDIS ARTERY WAS OBSERVED. AN ANGIOGRAPHY REVEALED DISPERSION OF BLOOD CLOTS TO THE DORSALIS PEDIS ARTERY, RESULTING IN REDUCED BLOOD FLOW. AS NO OCCLUSION WAS OBSERVED, PHARMACOLOGIC THERAPY (ALPROSTADIL) WAS INITIATED, AND THE PHYSICIAN DECIDED TO FOLLOW UP WITH THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN'S COMMENT: "THE CONDITION OF THE ACCESS VESSELS AND THE COMMON ILIAC ARTERY WAS POOR."

  Patient problems: Embolism/Embolus

  MAUDE report 22216910 ↗
• InjuryMay 14, 2025Difficult to Advance; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). DUE TO THE NARROW ACCESS VESSELS (LEFT: 5.2 ¿ 8.4 MM, RIGHT: 5.8 - 9.3 MM), ENDARTERECTOMY WAS PERFORMED FOR APPROXIMATELY 3 CM FROM THE PUNCTURE SITES OF THE COMMON FEMORAL ARTERIES ON BOTH SIDES, AND THEN THE DEVICES WERE INSERTED. THE INSERTION OF THE 16 FR DSF SHEATH ON THE LEFT SIDE AND THE 12 FR DSF SHEATH ON THE RIGHT SITE WAS CHALLENGING, AND THEY WERE INSERTED WITH BALLOON ASSISTANCE. AFTER SUCCESSFULLY DEPLOYING THE EXCC, ANGIOGRAPHY CONFIRMED THE OCCLUSION OF THE RIGHT INTERNAL ILIAC ARTERY. IT WAS CONSIDERED THAT PLAQUE SHIFT MIGHT HAVE OCCURRED UNTIL THE SUCCESSFUL INSERTION OF THE DSF SHEATH. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: IT WAS CONSIDERED THAT PLAQUE SHIFT MIGHT HAVE OCCURRED UNTIL THE SUCCESSFUL INSERTION OF THE DSF SHEATH.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22016959 ↗
• InjuryMar 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE TO TREAT AN ANEURYSM UTILIZING MULTIPLE GORE DEVICES AND USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS ACCESSORY. THERE WAS A BLEEDING ISSUE IN THE LEFT GROIN AFTER THE 12FR SHEATH WAS REMOVED WHICH PHYSICIAN SAID WAS ATTRIBUTED TO THE ACCESS VESSEL COMPLICATION DUE TO PATIENT'S DISEASE CONDITION WITH TORTUOSITY AND HEAVY CALCIUM BUILDUP IN THE AREA AND THEY USED A VIABHAN STENT GRAFT TO FIX THE ACCESS VESSEL BLEEDING. THE FOLLOW UP CTA SHOWED SOME BLOOD IN THE RETROPERITONEAL SPACE CONSISTENT WITH BLEEDING FROM THE ACCESS COMPLICATION. THE PROCEDURE WAS AROUND 5 HOURS AND WENT RELATIVELY SMOOTH WITH ALL GORE DEVICES IMPLANTED SUCCESSFULLY AND PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD PASSED AWAY DUE TO SUFFERING A HEART ATTACK. ON MARCH 10, 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED OF THE ABOVE EVENT BY THE PHYSICIAN ON PATIENT'S PASSING. REPORTEDLY, POST OP DAY 1, THE NIGHT FOLLOWING THE PROCEDURE, THE PATIENT WAS STABLE AND DOING WELL. ON THE MORNING OF POST OP DAY 2, PATIENT'S HEMOGLOBIN DROPPED, AND PATIENT STARTED EXPERIENCING BACK PAIN. THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21701817 ↗
• InjuryFeb 4, 2025Patient Device Interaction Problem; Patient Device Interaction 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 FOR THE LEFT ACCESS WITHOUT INSERTION RESISTANCE. AFTER ALL STENT GRAFTS WERE IMPLANTED, AN ACCESS ANGIOGRAPHY REVEALED A LOCALIZED DISSECTION IN THE LEFT EXTERNAL ARTERY. ALSO A BLOOD PRESSURE DIFFERENCE WAS OBSERVED. FOR TREAT, A BARE METAL STENT, EPIC 10 MM - 60 MM, WAS IMPLANTED. AN ANGIOGRAPHY REVEALED THAT THE DISSECTION WAS RESOLED. ALSO THE BLOOD PRESSURE DIFFERENCE WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE HAD ORIGINALLY ANTICIPATED THAT THE PATIENT WOULD HAVE DIFFICULTY ADVANCING THE DSF DUE TO THE NARROW ACCESS VESSEL. THE DISSECTION WAS PROBABLY CREATED AT THE TIME OF DSF INSERTION, BUT THAT IT WAS UNAVOIDABLE CONSIDERING THE ACCESS VESSEL DIAMETER.

  Patient problems: Vascular Dissection

  MAUDE report 21309480 ↗
• DeathJan 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING DEBRANCHING AND CHIMNEY TECHNIQUE FOR A DISTAL ARCH AORTIC ANEURYSM WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER DEBRANCHING, THE LEFT SUBCLAVIAN ARTERY WAS PLUG EMBOLISED AND A TGM343415J WAS IMPLANTED DISTALLY. A TGM404020J WAS THEN INSERTED, BUT TGM404020J WAS NOT DEPLOYED AT THIS POINT AS IT WAS TO BE DEPLOYED SIMULTANEOUSLY WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC161200J) TO BE IMPLANTED IN THE BRACHIOCEPHALIC ARTERY. AN 8FR NON-GORE SHEATH, A RADIFOCUS¿ GUIDEWIRE, AND AN ANGIOGRAPHIC CATHETER WERE INSERTED FROM THE RIGHT SUBCLAVIAN ARTERY AND SUCCESSFULLY PASSED TO THE ASCENDING AORTA, BUT THE BRACHIOCEPHALIC ARTERY WAS HIGHLY TORTUOUS AND REMAINED TORTUOUS EVEN AFTER THE GUIDEWIRE WAS REPLACED WITH A STIFF TYPE. THE SHEATH WAS REPLACED WITH A DSF1233 AND INSERTED, WHICH PASSED THROUGH WITHOUT RESISTANCE, BUT THE BRACHIOCEPHALIC ARTERY REMAINED TORTUOUS. AN ATTEMPT WAS MADE TO UNSHEATHE THE PLC161200J AFTER DELIVERY TO THE ASCENDING AORTA THROU

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 21108177 ↗
• InjuryAug 5, 2024Difficult to Remove; Difficult to Remove

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A LEFT LIMB SYMPTOMATIC VENOUS OBSTRUCTION USING TWO GORE® VIAFORT VASCULAR STENTS. A GORE® DRYSEAL SHEATH WAS USED TO ACCESS THE LEFT COMMON FEMORAL VEIN DURING THE PROCEDURE. ACCORDING TO THE REPORT, ACCESS SITE COMPLICATIONS WERE NOTED WHEREBY THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE DEVICE DELIVERY CATHETER OUT OF THE SHEATH. THE NATURE OF THE ACCESS SITE COMPLICATIONS AND THE CAUSE OF THE DIFFICULTY IN WITHDRAWING THE DELIVERY SYSTEM THROUGH THE SHEATH ARE UNKNOWN. THE PHYSICIAN REPORTEDLY PULLED THE DELIVERY SYSTEM PARTIALLY INTO THE SHEATH. AN ATTEMPT WAS MADE TO REMOVE THE SHEATH AND DELIVERY SYSTEM TOGETHER, BUT BOTH REPORTEDLY GOT STUCK AT THE LEVEL OF THE VENOTOMY. IT WAS REPORTED THE PHYSICIAN MADE A SURGICAL CUTDOWN TO REMOVE THE SHEATH AND STENT DELIVERY SYSTEM TOGETHER TO MINIMIZE VESSEL DAMAGE. BLOOD LOSS WAS ESTIMATED AT 30ML, AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS CONCLUDED WITHOUT ANY FURTHER REPORTED ADVERSE EVENTS, AND THE PATIENT TOLERATED THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE BY GORE TO OBTAIN ADDITIONAL EVENT INFORMATION; HOWEVER, NO FURTHER INFORMATION WAS PR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19906686 ↗
• InjuryJun 28, 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 THE BRACHIOCEPHALIC ARTERY USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (INTERNAL ILIAC COMPONENT). IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN ARCH AORTA REPLACEMENT BEFORE THIS PROCEDURE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT AXILLARY ARTERY AND THE INTERNAL ILIAC COMPONENT WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY FROM THE BIFURCATION OF THE RIGHT COMMON CAROTID ARTERY. A FINAL ANGIOGRAPHY REVEALED A DISSECTION IN THE RIGHT SUBCLAVIAN ARTERY. IT SEEMED THAT THE DISSECTION OCCURRED FROM AROUND THE DISTAL END OF THE INTERNAL ILIAC COMPONENT. THE PHYSICIAN DECIDED TO MONITOR THE DISSECTION, BECAUSE THE BLOOD FLOW OF THE RIGHT SUBCLAVIAN ARTERY WAS NORMAL AND THERE WAS NO APPROPRIATE DEVICE TO TREAT THIS DISSECTION. THE PHYSICIAN STATED THAT IT IS UNKNOWN WHY THE DISSECTION OCCURRED AND THE POSSIBILITY OF THAT THE SHEATH WAS INVOLVED TO THE DISSECTION MIGHT BE LOW BECAUSE IT WAS CONFIRMED BY AN ANGIOGRAPHY THERE WAS NO DISSECTION BEFORE THE INTERNAL ILIAC COMPONENT WAS DEPLOYED. THE PHYSICIAN ALSO SAID A TOUCH-UP USING A NON-GORE BALLOON

  Patient problems: Vascular Dissection

  MAUDE report 19631234 ↗
• MalfunctionApr 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT THE SECOND PHASE OF STAGED ENDOVASCULAR TREATMENT FOR THE LEFT COMMON ILIAC ARTERY ANEURYSM AND LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AFTER DEPLOYMENT OF THE STENT GRAFT, NON-GORE BALLOON CATHETER (HYPERFLEX) WAS INSERTED, BUT IT STOPPED ADVANCING PAST THE VALVE OF THE 12FR DSF. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT, A WIRE THAT APPEARED TO BE THE COIL OF DSF WAS ENTANGLED WITH THE BALLOON. THE PROCEDURE WAS CONTINUED USING A 14FR DSF. NO ADVERSE EVENT WAS REPORTED. THE PHYSICIAN STATED THE FOLLOWING. I HAVE USED SIMILAR COMBINATIONS BEFORE, BUT THIS IS MY FIRST EXPERIENCE WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126277 ↗
• InjuryApr 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. THEY ATTEMPTED TO INSERT THE 22FR SHEATH FROM THE RIGHT COMMON FEMORAL ARTERY, BUT IT FAILED WITH STRONG RESISTANCE. SUBSEQUENTLY, A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED VIA CONTRAST IMAGING. A 12FR SHEATH WAS INSERTED FROM THE LEFT COMMON FEMORAL ARTERY AND A STENT GRAFT WAS IMPLANTED TO COVER THE RUPTURED SITE AS A TREATMENT. OTHER ATTEMPTS WERE MADE TO ADVANCE THE 20FR AND 22FR SHEATHS FROM THE LEFT COMMON FEMORAL ARTERY. 20FR COULD BE ADVANCED BUT 22FR FAILED AGAIN, SO THEY DECIDED TO TERMINATE THE PROCEDURE. THE PULSE OF THE LEFT COMMON FEMORAL ARTERY WAS WEAK WHILE SUTURING. THE CONTRAST IMAGING REVEALED A DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY, AND A BARE STENT WAS PLACED AS A TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: A DISSECTION CAVITY MAY HAVE FORMED AT THE PUNCTURE SITE. THE PATIENT¿S VESSELS WERE ORIGINALLY NOT STURDY ENOUGH, WHICH MAY HAVE CAUSED THE RUPTURE.

  Patient problems: Vascular Dissection

  MAUDE report 19010032 ↗

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.