GORE DRYSEAL FLEX Introducer Sheath DSF1833Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00733132630042), received between Oct 5, 2018 and Jul 16, 2026 — classified as 4 deaths, 71 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 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 86 reports, in the reporter's own words as published by the FDA.

• DeathJul 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICES WERE PLACED IN THE BILATERAL RENAL ARTERIES USING THE CHIMNEY TECHNIQUE. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS, AND THE GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS USED FOR TOUCH-UP. AFTER ALL DEVICES WERE PLACED, DIGITAL SUBTRACTION ANGIOGRAPHY(DSA) REVEALED SLOW FLOW IN THE BILATERAL RENAL ARTERIES, AND THE RIGHT SIDE VBX DEVICE WAS SLIGHTLY KINKED. A TYPE II ENDOLEAK WAS ALSO OBSERVED IN THE RIGHT RENAL ARTERY; THEREFORE, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY. THE SLOW FLOW WAS SLIGHTLY IMPROVED, AND THE PHYSICIAN ELECTED TO MONITOR IT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT DEVELOPED MULTIPLE CEREBRAL INFARCTIONS AND EXPIRED. IT WAS REPORTED THAT THE PATIENT HAD A SIGNIFICANT SHAGGY AORTA.

  Patient problems: Ischemia Stroke

  MAUDE report 25834728 ↗
• InjuryJul 14, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG ENDOPROSTHESIS) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. AFTER ALL DEVICES WERE IMPLANTED, A DISTAL TYPE I ENDOLEAK FROM A CONTRALATERAL LEG ENDOPROSTHESIS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY WAS OBSERVED. TO RESOLVE THE DISTAL TYPE I ENDOLEAK, AN ATTEMPT WAS MADE TO PUSH THE CONTRALATERAL LEG UPWARD USING AN 18FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. TWO AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED, AND BALLOONING USING A NON-GORE BALLOON CATHETER WAS PERFORMED BEFORE AND AFTER THEIR IMPLANTATION. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. ANGIOGRAPHY REVEALED A DISSECTION AT THE ORIGIN OF THE RIGHT INTERNAL ILIAC ARTERY, ALONG WITH LOSS OF BLOOD FLOW DUE TO THE DISSECTION. IT WAS REPORTED THAT THE DISSECTION MIGHT HAVE OCCURRED DURING THE TREATMENT OF THE DISTAL TYPE I ENDOLEAK, INCLUDING PUSHING THE CONTRALATERAL LEG UPWARD USING THE 18FR SHEATH AND BALLOONING BEFORE AND AFTER THE IMPLANTATION OF THE AORTIC EXTENDER ENDOPROSTHESES. ANY NECESSARY TREATMENT FOR TH

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 25820878 ↗
• MalfunctionApr 16, 2026Break; Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN UNKNOWN INDICATION USING TREO ABDOMINAL STENT-GRAFT SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER DEPLOYMENT OF THE STENT GRAFT AND REMOVAL OF THE DELIVERY CATHETER, BLOOD LEAKAGE DUE TO DRYSEAL VALVE BREAKAGE WAS NOTICED. ANOTHER SHEATH WAS USED FOR THE REMAINING PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893024 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak; Unintended Deflation

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, DURING THE PROCEDURE USING A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH, A LEAK WAS NOTICED DUE TO A DEFLATION OF THE VALVE. THIS WAS QUICKLY REFILLED WITH THE CORRESPONDING SYRINGE, RODS AND SCREW ON THE STOPPER. THE SAME LOSS OF PRESSURE HAPPENED TWICE MORE. COMPRESSES ARE WEIGHED AND IT IS ESTIMATED THAT THE PATIENT LOST 650 ML OF BLOOD FROM THE LEAK. A NEW GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO BLOOD TRANSFUSION WAS NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307480 ↗
• InjuryDec 10, 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 ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, AN ANGIOGRAPHY FOR THE ACCESS VESSELS FOUND VASCULAR DISSECTION ON THE LEFT EXTERNAL ILIAC ARTERY. A BARE-METAL STENT WAS PLACED TO FIX THE DISSECTION. ALSO, AT THE PUNCTURE SITE OF THE LEFT FEMORAL ARTERY, PERCLOSE DEVICE DID NOT WORK WELL AND SURGICAL REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, DIAMETER OF THE DISSECTED EXTERNAL ILIAC ARTERY WAS 3.7 TO 6.7 MM AND NARROWER THAN THE SHEATH OF 18 FR.

  Patient problems: Vascular Dissection

  MAUDE report 23770972 ↗
• InjuryDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING PUBLICATION WAS REVIEWED BY GORE: OMOTE K, KAMADA T, FURUGEN M, ET AL. FEMORO-FEMORAL BYPASS FOR A VASCULAR COMPLICATION DURING TRANSFEMORAL AORTIC VALVE IMPLANTATION. CUREUS 2025;17(3):E81239. HTTPS://DOI.ORG/10.7759/CUREUS.81239. A (B)(6) YEAR-OLD WOMAN UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) FOR TREATMENT OF SEVERE AORTIC STENOSIS (AS) ON (B)(6) 2024. FINAL ANGIOGRAPHY SHOWED THE RIGHT EXTERNAL ILIAC ARTERY OCCLUSION DUE TO VASCULAR INJURY RELATED TO A LARGE-DIAMETER INTRODUCER SHEATH (GORE® DRYSEAL FLEX INTRODUCER SHEATH). ALTHOUGH WE PERFORMED ENDOVASCULAR THERAPY, NO GUIDEWIRES COULD CROSS THE CULPRIT LESION BECAUSE THE INTIMA HAD FRAPPED AND OCCLUDED THE VESSEL LUMEN. THEREFORE, WE PERFORMED FEMORO-FEMORAL BYPASS (GORE® PROPATEN® VASCULAR GRAFT) FOR BAILOUT OF ACUTE LIMB ISCHEMIA. FEMORO-FEMORAL BYPASS IS A LESS INVASIVE, SHORTER OPERATION TIME AND THEREFORE A REASONABLE STRATEGY AS AN URGENT BAILOUT FOR VASCULAR COMPLICATIONS DURING TAVI IN SUPER-AGED OR HIGHER-RISK SURGICAL PATIENTS WITH SEVERE AS.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 23723042 ↗
• InjuryNov 21, 2025Entrapment of Device; Difficult to Advance; Migration; Entrapment of Device; Difficult to Advance; Migration

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT (RLT281412), GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG (PLC) DEVICES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE RLT DEVICE WAS ADVANCED OVER THE DSF1833 (SN: (B)(6)). THE PHYSICIAN CONFIRMED THE PROXIMAL LANDING ZONE EXACTLY BELOW THE RENAL ARTERIES AND THEN CONTINUED WITH THE IMPLANT OF THE PLC DEVICE ON THE LEFT SIDE. THE PHYSICIAN CONTINUED WITH MEASURING THE LENGTH FOR THE LEFT SIDE FOR THE CONTRALATERAL LEG (PLC121200). THE TRUNK REPOSITIONING MECHANISM WAS RELEASED AT THE INTENDED POSITION. WHEN ATTEMPTING TO CANNULATE THE DISTAL END OF THE IPSI-LATERAL LEG WITH THE DRYSEAL DSF1833 TO EXTEND THIS DEVICE WITH A PLC121000, SLIGHT RESISTANCE WAS NOTED. SUBSEQUENT FLUOROSCOPY IMAGING REVEALED THE TRUNK HAD MIGRATED PROXIMALLY RESULTING IN A SIGNIFICANT GAP BETWEEN THE CONTRALATERAL LEG (PLC) AND THE CONTRALATERAL LEG GATE OF THE TRUNK. COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING CONFIRMED THAT THE TRUNK'S PROXIMAL END WAS ABOVE THE CELIAC TRUNK. REPORTEDLY, THE PHYSICIAN WAS SURE THE DILATOR TIP W

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 23622306 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6)2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT ON THE THORACIC AORTA FOR AN UNKNOWN INDICATION USING A FENESTRATED PHYSICIAN-MODIFIED ENDOGRAFT (NON-GORE DEVICE; ZENITH ALPHA) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, A DRYSEAL VALVE LEAKAGE WAS FOUND FOLLOWING THE INSERTION OF THE SHEATH INTO THE PATIENT. SALINE WAS LEAKED FROM THE VALVE AND BLEEDING COULD NOT BE STOPPED. THE PHYSICIAN ATTEMPTED TO INFLATE THE VALVE FOR MULTIPLE TIMES; HOWEVER, THE SAME THINGS HAPPENED AGAIN. ANOTHER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE SHEATH WAS USED APPROPRIATELY AS USUAL. DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059634 ↗
• InjuryJul 31, 2025Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH(DSF SHEATH) WAS USED FOR ACCESS. REPORTEDLY, THE PATIENT HAD UNDERGONE AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS AT A DIFFERENT HOSPITAL. AN ATTEMPT WAS MADE TO INSERT A 22FR DSF SHEATH FROM THE LEFT FEMORAL ARTERY, BUT IT COULD NOT BE ADVANCED. EVEN USING ONLY THE DILATOR WAS UNSUCCESSFUL. AFTER SWITCHING TO AN 18FR DSF SHEATH, IT WAS POSSIBLE TO ADVANCE IT DESPITE SOME RESISTANCE. A SECOND ATTEMPT WITH THE 22FR DILATOR WAS AGAIN UNSUCCESSFUL. THE APPROACH WAS THEN CHANGED TO THE RIGHT SIDE, BUT IT WAS DETERMINED THAT ADVANCING A SHEATH LARGER THAN 18FR DSF SHEATH WOULD BE DIFFICULT. A FINAL ATTEMPT WAS MADE FROM THE LEFT SIDE, AND ALTHOUGH THERE WAS SIGNIFICANT RESISTANCE, THE 22FR DSF SHEATH WAS SUCCESSFULLY ADVANCED AND THE STENT GRAFT WAS DEPLOYED AS PLANNED. UPON REMOVING THE 22FR DSF SHEATH, THROMBOTIC STENOSIS WAS OBSERVED EXTENDING FROM THE INSIDE OF THE PREVIOUSLY PLACED STENT GRAFT TO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT INTERNAL ILIAC ARTERY WAS ALSO FOUND TO BE THROMBOSED AN

  Patient problems: Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 22683725 ↗
• InjuryJul 29, 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 AORTIC ANEURYSM AND A LEAK FROM THE ASCENDING AORTIC REPLACEMENT SITE, USING A GORE DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. AN 18FR SHEATH WAS INSERTED VIA THE LEFT AXILLARY ARTERY, AND TWO STENT GRAFTS WERE DEPLOYED. SUBSEQUENTLY, CONTRAST IMAGING REVEALED A DISSECTION OF THE LEFT VERTEBRAL ARTERY. AS THERE WAS NO IMPACT ON BLOOD FLOW, NO FURTHER INTERVENTION WAS PERFORMED, AND THE PATIENT WAS PLACED UNDER FOLLOW-UP OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 22641855 ↗
• InjuryJul 3, 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 AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. AFTER HEMOSTASIS, THE PULSE IN THE LEFT FEMORAL ARTERY COULD NOT BE DETECTED. UPON PERFORMING ANGIOGRAPHY AGAIN, NO BLOOD FLOW WAS OBSERVED NEAR THE LEFT EXTERNAL ILIAC ARTERY. AN INCISION WAS MADE AT THE LEFT PUNCTURE SITE, AND A THROMBUS WAS IDENTIFIED. THROMBECTOMY WAS PERFORMED. RESTORATION OF BLOOD FLOW WAS CONFIRMED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22401492 ↗
• InjuryMay 29, 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 AN AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. FOLLOWING THE PLACEMENT OF STENT GRAFTS, THE 18FR SHEATH WAS REMOVED. IT WAS CONFIRMED THAT THE BLOOD PRESSURE IN THE LEFT LOWER EXTREMITY REMAINED LOW, SO ANGIOGRAPHY WAS PERFORMED FROM THE CONTRALATERAL SIDE, AND STENOSIS DUE TO DISSECTION WAS OBSERVED IN THE LEFT EXTERNAL ILIAC ARTERY. AS A TREATMENT, A BARE METAL STENT WAS IMPLANTED AND POST-DILATATION WITH A PTA BALLOON CATHETER WAS PERFORMED. DUE TO THE MANIPULATION WITH PTA BALLOON, VESSEL RUPTURE OCCURRED IN THE FEMORAL ARTERY NEAR THE PUNCTURE SITE. BLEEDING AT THE PUNCTURE SITE WAS TREATED WITH COMPRESSION HEMOSTASIS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN MENTIONED THAT THE DISSECTION MAY HAVE FORMED DURING PUNCTURE, THE USED OF PERCLOSE DEVICE, CATHETER MANIPULATION, OR SHEATH INSERTION; HOWEVER, THE EXACT TIMING OF THE DISSECTION REMAINS UNKNOWN.

  Patient problems: Stenosis; Vascular Dissection

  MAUDE report 22103052 ↗
• InjuryMay 22, 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 (DSF). THE DSF WAS USED VIA RIGHT-SIDE ACCESS, AND RESISTANCE WAS NOTED DURING INSERTION. AFTER DEPLOYMENT OF THE STENT GRAFTS, THE DSF WAS REMOVED, AT WHICH POINT A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED. A BARE-METAL STENT WAS PLACED AT THE SITE OF THE DISSECTION, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Vascular Dissection

  MAUDE report 22075638 ↗
• InjuryApr 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) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR COARCTATION OF THE AORTA DUE TO VON RECKLINGHAUSEN'S DISEASE USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PROCEDURE WAS CONCLUDED WITHOUT ANY PROBLEMS. ON (B)(6) 2024, A FOLLOW-UP CT SCAN SHOWED DISSECTION ON THE RIGHT EXTERNAL ILIAC TO FEMORAL ARTERY, WHICH WAS THE ACCESS VESSEL OF THE SHEATH. DUE TO THE ANATOMICAL CONDITION, IT WAS DIFFICULT TO PLACE A STENT ON THE DISSECTION SITE; THEREFORE, IT WAS LEFT FOR MONITORING. ON AN UNKNOWN DATE, ANOTHER FOLLOW-UP CT SCAN REVEALED THAT THE FALSE LUMEN ALMOST DISAPPEARED AND THE TRUE LUMEN BECAME QUITE NARROW. BECAUSE OF THIS, STENT PLACEMENT WAS CONSIDERED IMPOSSIBLE. THUS, FEMOROFEMORAL BYPASSING WOULD BE PERFORMED IF THE PATIENT DEVELOPS ANY SUBJECTIVE SYMPTOMS. THE PATIENT WAS UNDER MONITORING AT THE TIME OF THIS REPORT. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: SINCE NO PROBLEMS WERE FOUND DURING THE INDEX PROCEDURE, IT COULD NOT BE CONCLUDED THAT THE DISSECTION WAS CAUSED BY THE SHEATH; HOWEVER, THE POSSIBILITY COULD NOT BE DENIED EITHE

  Patient problems: Vascular Dissection

  MAUDE report 21932350 ↗
• InjuryMar 28, 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 ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT HAD VERY TORTUOUS ANATOMY IN THE LEFT EXTERNAL ILIAC ARTERY (EIA), AND WHEN ADVANCING THE SHEATH, RESISTANCE WAS FELT. ALL THE PLANNED DEVICES WERE IMPLANTED SUCCESSFULLY. DURING A CONFIRMATION ANGIOGRAPHY, DISSECTION OF THE LEFT EIA WAS FOUND. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADDITIONALLY PLACED ON THE DISSECTED SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PATIENT HAD SEVERELY TORTUOUS ANATOMY, SO THE DISSECTION WAS WITHIN EXPECTATION. IT OCCURRED WHEN THE LEFT EIA WAS STRAIGHTENED BY THE SHEATH.

  Patient problems: Vascular Dissection

  MAUDE report 21716566 ↗
• InjuryMar 13, 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 EMERGENCY ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AFTER DEPLOYING THE STENT GRAFTS AND REMOVING THE DSF, ACCESS VESSEL INJURY WAS SUSPECTED. AS A TREATMENT, A BARE METAL STENT WAS PLACED. ANGIOGRAPHY CONFIRMED AN EMBOLISM BELOW THE KNEE CAUSED BY THROMBUS. THROMBECTOMY AND SURGICAL REPAIR INVOLVING ENDARTERECTOMY WERE CARRIED OUT.

  Patient problems: Embolism/Embolus

  MAUDE report 21590945 ↗
• 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 21466940 ↗
• InjuryFeb 19, 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 AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IT WAS REPORTED THAT THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY HAD APPROXIMATELY 90% STENOSIS PRIOR TO THE PROCEDURE. AFTER THE STENT GRAFT PLACEMENT, THE DSF WAS REMOVED AND HEMOSTASIS WAS PERFORMED, BUT BLOOD FLOW IN THE LEFT LOWER LIMB COULD NOT BE CONFIRMED. BLOOD FLOW AT THE PUNCTURE SITE WAS CONFIRMED, BUT THERE WAS NO BLOOD FLOW BEYOND THE STENOSIS. IT WAS CONSIDERED THAT THE STENOSIS HAD OCCLUDED. THE STENOSIS SITE WAS CUT DOWN, AND THROMBECTOMY AND ENDARTERECTOMY WERE PERFORMED. THE PHYSICIAN STATED THE FOLLOWING: THE EXTERNAL ILIAC ARTERY WAS SIGNIFICANTLY TORTUOUS, AND IT IS POSSIBLE THAT A THROMBUS WAS EMBOLIZED DURING THE PLACEMENT OF THE IBE. HOWEVER, THE PRIMARY CAUSE IS BELIEVED TO BE THE PRE-EXISTING 90% STENOSIS.

  Patient problems: Embolism/Embolus

  MAUDE report 21408716 ↗
• InjuryJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6), 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED RIGHT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. A 18FR SHEATH WAS INSERTED FROM THE RIGHT SIDE. AFTER ALL PLANNED STENT GRAFTS WERE SUCCESSFULLY IMPLANTED, ANGIOGRAPHY FOR THE ACCESS ROUTE REVEALED DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY (MORE DISTAL THAN THE DISTAL END OF THE STENT GRAFT). FOR REPAIR, A BARE METAL STENT WAS IMPLANTED. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: THE RIGHT EXTERNAL ILIAC ARTERY WAS HIGHLY TORTUOUS, WHICH MADE GUIDEWIRE EXCHANGE DIFFICULT. IT IS THOUGHT THAT A VERY STRONG FORCE WAS APPLIED DURING THE GUIDEWIRE EXCHANGE, WHICH MAY HAVE CAUSED THE DISSECTION AT THAT TIME.

  Patient problems: Vascular Dissection

  MAUDE report 21269768 ↗
• MalfunctionDec 4, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE WHERE THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. REPORTEDLY, THE DSF1833 WAS USED ON THE LEFT SIDE AND ON THROUGH-WIRE TO GO UP AND OVER INTO THE GATE OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). IT WAS REPORTED THAT UPON REMOVAL OF THE DILATOR OF THE DSF1833, THE TIP OF DILATOR WAS SPLIT. THE DILATOR WAS NO LONGER USABLE TO CONTINUE THE CASE AND HAD TO USE A NEW DSF1833 DILATOR. THE SHEATH WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE FOR ANALYSIS. ACCORDING TO THE INFORMATION PROVIDED, THERE WAS NOTHING IN PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. THE NURSE INSPECTED THE SHEATH BEFORE USING, AND THE SHEATH LOOKED NORMAL BEFORE USE. NOTHING WRONG WAS WITH AN IBE DEVICE, AND THE SHEATH DILATOR TIP DID NOT CATCH ON THE DEVICE. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE PROBLEM WAS POSSIBLY DUE TO THROUGH-WIRE. IT WAS REPORTED THAT THE SHEATH WAS NOT EXCHANGED DURING THE PROCEDURE, ONLY A DILATOR. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 20849781 ↗
• InjuryOct 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. THE DSF SHEATH WAS INSERTED FROM RIGHT SIDE. IT WAS REPORTED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY(PTA) WAS PERFORMED FROM RIGHT COMMON ILIAC ARTERY DOWN TO THE RIGHT EXTERNAL ILIAC ARTERY DUE TO THE VESSEL WAS NARROW, BUT THE PHYSICIAN STILL FELT A RESISTANCE WHILE ADVANCING THE DSF SHEATH AROUND THE RIGHT EXTERNAL ILIAC ARTERY. AFTER ALL STENT GRAFTS WERE PLACED, A DISSECTION ON THE RIGHT EXTERNAL ILIAC ARTERY WAS REVEALED ON AN ACCESS ANGIOGRAPHY. A BARE STENT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 20478122 ↗
• InjuryAug 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING PROCEDURE, AFTER SURGICAL INCISION CLOSURE, IT WAS FOUND THAT THE PULSE OF THE LEFT LOWER EXTREMITY WAS WEAKENED AND AN ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED THAT A GORE® DRYSEAL FLEX INTRODUCER SHEATH HAD BEEN MISTAKENLY INSERTED FROM THE SUPERFICIAL FEMORAL ARTERY BUT NOT THE COMMON FEMORAL ARTERY AND THE ACCESS VESSEL WAS INJURED. THE SUPERFICIAL FEMORAL ARTERY WAS REPLACED WITH A GRAFT (GORE® PROPATEN® VASCULAR GRAFT) AND A BARE-METAL STENT WAS PLACED DISTAL TO THE GRAFT. SINCE EMBOLIZATION OF THE LEFT LOWER EXTREMITY DUE TO DISPERSED THROMBUS WAS ALSO OBSERVED, THROMBUS RETRIEVAL WITH A FOGARTY WAS PERFORMED AS WELL. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PATIENT¿S FEMORAL BIFURCATION LEVEL WAS HIGH BASED ON THE PRE-OPERATIVE IMAGING.

  Patient problems: Embolism/Embolus; Perforation of Vessels

  MAUDE report 20073196 ↗
• InjuryJun 26, 2024Adverse 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) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON. AFTER ALL STENT GRAFTS WERE DEPLOYED, THE RIGHT RENAL ARTERY WAS NOT VISUALIZED DURING THE FINAL ANGIOGRAM. THE THROMBUS IN THE RIGHT RENAL ARTERY WAS ASPIRATED, AND APPROXIMATELY 60% OF THE BLOOD FLOW WAS SECURED. TYPE II ENDOLEAK WAS NOTED, BUT NO SPECIFIC TREATMENT WAS REPORTED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THE FOLLOWING: ALTHOUGH IT WAS SHAGGY AORTA, IT WAS NOT EXPECTED THE BLOOD CLOT TO SCATTER LIKE THIS. IT IS ALSO UNCLEAR WHEN THE CLOT SCATTERED.

  Patient problems: Embolism/Embolus

  MAUDE report 19620806 ↗
• InjuryJun 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024 A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS BEING USED AN ACCESSORY WITH NON-GORE DEVICES TO CLEAR A BLOOD CLOT. . AT SOME POINT IN THE PROCEDURE, SIGNIFICANT BLEEDING WAS NOTICED THROUGH THE ONE-WAY VALVE. THE DECISION WAS MADE TO REPLACE THE DEVICE WITH A DIFFERENT DSF. HOWEVER, THE NEW DSF ALSO HAD SIGNIFICANT BLEEDING THROUGH THE ONE-WAY VALVE. THE PATIENT LOST A SIGNIFICANT AMOUNT OF BLOOD (APPROXIMATELY 4-5 UNITS). THE PATIENT UNDERWENT A TRANSFUSION AND IS STABLE. BECAUSE THE PRIMARY PROCEDURE WAS NOT CONDUCTED WITH GORE DEVICE, THE FSA WAS NOT PRESENT AT THIS EVENT. THE FSA REPORTED THAT IT WAS INDICATED TO HIM THAT IN BOTH CASES, THE VALVE LEAKAGE OCCURRED AFTER A DEVICE HAD BEEN ADVANCED THROUGH VALVE. HOWEVER, THE HOSPITAL RISK MANAGEMENT INDICATED THAT THIS INFORMATION WAS UNKNOWN, AND WOULD NOT BE PROVIDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19527807 ↗
• InjuryJun 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024 A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS BEING USED AN ACCESSORY WITH NON-GORE DEVICES TO CLEAR A BLOOD CLOT. AT SOME POINT IN THE PROCEDURE, SIGNIFICANT BLEEDING WAS NOTICED THROUGH THE ONE-WAY VALVE. THE DECISION WAS MADE TO REPLACE THE DEVICE WITH A DIFFERENT DSF. HOWEVER, THE NEW DSF ALSO HAD SIGNIFICANT BLEEDING THROUGH THE ONE-WAY VALVE. THE PATIENT LOST A SIGNIFICANT AMOUNT OF BLOOD (APPROXIMATELY 4-5 UNITS). THE PATIENT UNDERWENT A TRANSFUSION AND IS STABLE. BECAUSE THE PRIMARY PROCEDURE WAS NOT CONDUCTED WITH GORE DEVICE, THE FSA WAS NOT PRESENT AT THIS EVENT. THE FSA REPORTED THAT IT WAS INDICATED TO HIM THAT IN BOTH CASES, THE VALVE LEAKAGE OCCURRED AFTER A DEVICE HAD BEEN ADVANCED THROUGH VALVE. HOWEVER, THE HOSPITAL RISK MANAGEMENT INDICATED THAT THIS INFORMATION WAS UNKNOWN, AND WOULD NOT BE PROVIDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19527804 ↗

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.