GORE DRYSEAL FLEX Introducer Sheath DSF1633Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00733132630028), received between Jul 10, 2018 and Sep 24, 2026 — classified as 3 deaths, 117 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (45 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 135 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore from the iMedidata database: On (b)(6) 2026, the patient underwent endovascular treatment for an aortoiliac aneurysm. The patient was treated with GORE®¿EXCLUDER®¿Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis devices and GORE®¿EXCLUDER®¿Iliac Branch Endoprosthesis devices. The GORE® devices were successfully navigated to the intended location and successfully deployed. On (b)(6) 2026, the patient developed an infected inguinal pseudoaneurysm. A percutaneous transluminal angioplasty was performed to treat it.On (b)(6) 2026, the infected inguinal pseudoaneurysm was recovered / resolved with sequelae.

  Patient problems: Pseudoaneurysm; Unspecified Infection

  MAUDE report 50878505 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6), 2026, angiography revealed that the right internal iliac artery was patent.On (b)(4), 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm and common iliac artery aneurysms using GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) devices and GORE® DrySeal Flex Introducer Sheath (DSF) devices.Two DSFs were inserted into both femoral arteries, and a pull-through wire was created. The iliac branch component was deployed in the left common iliac artery via a DSF inserted through the right femoral artery, while the internal iliac component was deployed in the left internal iliac artery via a DSF inserted through the left femoral artery.Another iliac branch component was deployed in the right common iliac artery via a DSF inserted through the right femoral artery. After that, angiography revealed that the right internal iliac artery was occluded. The timing of the occlusion was unknown. The iliac branch component did not occlude the right internal iliac artery physically.The right internal iliac artery could not be cannulated due to the occlusion; therefore, the internal iliac gate of the iliac

  Patient problems: Obstruction/Occlusion

  MAUDE report 50515409 ↗
• InjuryAug 10, 2026Patient Device Interaction Problem

  The following information was reported to Gore:(b)(6), 2026, this patient underwent an endovascular treatment for abdominal aortic aneurysm using GORE® EXCLUDER® AAA Endoprosthesis and GORE® DrySeal Flex Introducer Sheath.A 16 Fr Sheath was smoothly inserted from the right femoral artery and all the planned devices were implanted successfully. The final angiography showed a vascular dissection on the right external iliac artery. A bare-metal stent was additionally implanted at the dissected site. The patient tolerated the procedure. The reporting physician commented as follows: There was no resistance during advancement of the sheath, so the cause of dissection was unclear.

  Patient problems: Vascular Dissection

  MAUDE report 50189511 ↗
• InjuryJul 14, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. FOLLOWING SUCCESSFUL STENT GRAFT IMPLANTATION, AN ACCESS VESSEL ANGIOGRAM REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. AS A TREATMENT, AN ADDITIONAL BARE-METAL STENT WAS IMPLANTED. VESSEL INJURY WAS ALSO IDENTIFIED AT THE RIGHT FEMORAL ARTERY PUNCTURE SITE. THE INJURY WAS SURGICALLY REPAIRED, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED. THE PHYSICIAN REPORTED THAT THE ACCESS VESSEL WAS SMALL SO THAT THE EVENT WAS CONSIDERED AN ANTICIPATED RISK UNDER THE CIRCUMSTANCES. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING BOTH INSERTION AND REMOVAL OF THE 16 FR SHEATH. THE DISSECTION OCCURRED IN A SEGMENT OF THE RIGHT EXTERNAL ILIAC ARTERY EXHIBITING CIRCUMFERENTIAL CALCIFICATION. THE VESSEL DIAMETER AT THE AFFECTED SITE WAS REPORTED TO BE APPROXIMATELY 4.7 MM.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 25821024 ↗
• InjuryJul 12, 2026Patient Device Interaction 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® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES, WITH GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. AFTER DEPLOYMENT OF ALL STENT GRAFTS, A VASCULAR INJURY OF THE RIGHT EXTERNAL ILIAC ARTERY WAS IDENTIFIED; THEREFORE, AN ADDITIONAL STENT GRAFT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED THAT THE INJURY WAS LIKELY CAUSED DURING GUIDEWIRE MANIPULATION, BUT THE EXACT CAUSE HAS NOT BEEN IDENTIFIED.

  Patient problems: Perforation of Vessels

  MAUDE report 25791715 ↗
• InjuryJul 12, 2026Patient Device Interaction 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® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES, WITH GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. AFTER DEPLOYMENT OF ALL STENT GRAFTS, A VASCULAR INJURY OF THE RIGHT EXTERNAL ILIAC ARTERY WAS IDENTIFIED; THEREFORE, AN ADDITIONAL STENT GRAFT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED THAT THE INJURY WAS LIKELY CAUSED DURING GUIDEWIRE MANIPULATION, BUT THE EXACT CAUSE HAS NOT BEEN IDENTIFIED.

  Patient problems: Perforation of Vessels

  MAUDE report 25791704 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICE, GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM DEVICES, AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (16FR AND 14FR). A 16FR SHEATH WAS INSERTED INTO THE LEFT EXTERNAL ILIAC ARTERY (LEIA), AND A TRUNK-IPSILATERAL LEG WAS INSERTED THROUGH THE LEIA. DURING DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG, IT MIGRATED DISTALLY; IT WAS FULLY DEPLOYED IN THAT POSITION. THE LENGTH OF THE MIGRATION WAS UNKNOWN. AN AORTIC EXTENDER WAS DEPLOYED TO EXTEND THE TRUNK-IPSILATERAL LEG PROXIMALLY. A 14FR SHEATH WAS INSERTED INTO THE RIGHT EXTERNAL ILIAC ARTERY (REIA), AND A CONTRALATERAL LEG DEVICE WAS INSERTED THROUGH THE REIA. VASCULAR ACCESS ANGIOGRAPHY REVEALED DISSECTIONS IN THE RIGHT AND LEFT EXTERNAL ILIAC ARTERIES. STENTS WERE PLACED IN THE RIGHT AND LEFT EXTERNAL ILIAC ARTERIES TO TREAT THE DISSECTIONS. REPORTEDLY, THE MINIMUM DIAMETER OF THE PATIENT'S LEIA WAS 3.0 MM; IT WAS SMALLER THAN THE OUTER DIAMETER OF THE 16FR SHEATH (6.0 MM). ALSO, THE MINIMUM DIAMETER OF THE PATIENT'S REIA WAS 2.6 MM; I

  Patient problems: Vascular Dissection

  MAUDE report 25326056 ↗
• InjuryMay 24, 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, GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH DEVICES. AFTER ALL DEVICES WERE IMPLANTED, ANGIOGRAPHY REVEALED A LOCALIZED DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY. A STENT WAS IMPLANTED TO COVER THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THERE WAS RESISTANCE DURING INSERTION OF THE 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. IT WAS REPORTED THAT THERE WAS STRONG CALCIFICATION IN THE ACCESS VESSEL. THE DIAMETER OF THE LEFT EXTERNAL ILIAC ARTERY WAS ABOUT 8.4 ¿ 9.6 MM.

  Patient problems: Vascular Dissection

  MAUDE report 25267292 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. A 16 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY. FOLLOWING STENT GRAFT DEPLOYMENT, ACCESS ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS DETERMINED THAT NO ADDITIONAL INTERVENTION WAS REQUIRED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN MENTIONED THAT THE ACCESS VESSEL WAS SMALL IN DIAMETER, AND ACCESS INJURY WAS ANTICIPATED.

  Patient problems: Vascular Dissection

  MAUDE report 24933876 ↗
• InjuryApr 2, 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. AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, AN INTRAOPERATIVE ANGIOGRAPHY FOR THE ACCESS VESSEL SHOWED VASCULAR DISSECTION ON THE PROXIMAL PORTION OF LEFT FEMORAL ARTERY. A CUT-DOWN WAS MADE ON THE FEMORAL ARTERY AND A BARE-METAL STENT WAS ADDITIONALLY IMPLANTED AT THE DISSECTED SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THERE WAS SOME RESISTANCE WHEN INSERTING THE SHEATH INTO THE PATIENT; THEREFORE, THE DISSECTION PROBABLY OCCURRED AT THAT TIME.

  Patient problems: Vascular Dissection

  MAUDE report 24762507 ↗
• InjuryMar 31, 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® AAA ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, AN ANGIOGRAPHY SHOWED A DISSECTION ON THE LEFT EXTERNAL ILIAC ARTERY. AN ADDITIONAL BARE-METAL STENT WAS PLACED TO COVER THE DISSECTION. REPORTEDLY, THE VESSEL DIAMETER OF THE DISSECTED SITE WAS 5.6 MM TO 8.2 MM. ALSO, THERE WAS A TYPE II ENDOLEAK REMAINING, BUT NO TREATMENT WAS GIVEN AND IT WAS LEFT FOR MONITORING. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PATIENT¿S ACCESS VESSEL WAS IN A POOR CONDITION, SO ACCESS VESSEL INJURY WAS WITHIN EXPECTATION.

  Patient problems: Vascular Dissection

  MAUDE report 24739978 ↗
• InjuryMar 30, 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 PATIENT HAD SEVERE CALCIFICATION ON BILATERAL ACCESS VESSELS. ON THE LEFT SIDE, DSF1633 WAS ABLE TO BE ADVANCED WITHOUT RESISTANCE; HOWEVER, AFTER ALL THE PLANNED DEVICES WERE IMPLANTED, AN ANGIOGRAPHY SHOWED DISSECTION ON THE LEFT EXTERNAL ILIAC ARTERY. A BARE-METAL STENT WAS ADDITIONALLY PLACED TO COVER THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE ACCESS VESSELS WERE NARROW AND SEVERELY CALCIFIED. A BARE-METAL STENT WAS PLANNED TO BE PLACED EVEN IF THE DISSECTION HAD NOT OCCURRED. REPORTEDLY, THE EXTERNAL ILIAC ARTERY DIMETER WAS 3.98 TO 6.60 MM FOR THE LEFT SIDE.

  Patient problems: Vascular Dissection

  MAUDE report 24727962 ↗
• 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 24493285 ↗
• 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 24437791 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, BLOOD LEAKAGE WAS OBSERVED FROM THE DEVICE. ALTHOUGH VALVE EXPANSION WAS PERFORMED, THE LEAKAGE PERSISTED. THE DEVICE WAS REPLACED WITH AN ALTERNATIVE PRODUCT TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374072 ↗
• InjuryJan 13, 2026Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR BILATERAL ILIAC ARTERY ANEURYSMS USING GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESES, AND GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. WHILE DELIVERING THE INTERNAL ILIAC COMPONENT, THE DELIVERY CATHETER AND THE PULL-THROUGH WIRE BECAME ENTANGLED. IT WAS RESOLVED AFTER MULTIPLE ATTEMPTS AT RE-CANNULATION, AND DEPLOYMENT WAS SUCCESSFULLY COMPLETED. UPON REMOVAL OF THE DELIVERY CATHETER, THE LEADING OLIVE WAS FOUND TO HAVE REMAINED INSIDE THE ANEURYSM SAC; HOWEVER, AS THE STIFF WIRE HAD ALREADY BEEN REMOVED, IT WAS LEFT WITHIN THE ANEURYSM SAC. IN ADDITION, A DISSECTION WAS OBSERVED NEAR THE PUNCTURE SITE OF THE RIGHT COMMON FEMORAL ARTERY, WHICH WAS SURGICALLY REPAIRED. IT WAS ALSO REPORTED THAT THERE WAS A RESISTANCE WHILE ADVANCING THE 16FR SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24054587 ↗
• InjuryDec 24, 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 PSEUDOANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER STENT GRAFT PLACEMENT, ANGIOGRAPHY REVEALED A TYPE II ENDOLEAK. DURING SHEATH REMOVAL, INTIMAL INJURY AT THE PUNCTURE SITE WAS OBSERVED, AS A TREATMENT SURGICAL REPAIR WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Perforation of Vessels

  MAUDE report 23891370 ↗
• InjuryDec 22, 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, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN IMPENDING RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. AFTER THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS (GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS) WAS DEPLOYED, CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED VIA THE RIGHT ACCESS. HOWEVER, THE WIRE AND CATHETER COULD NOT BE ADVANCED THROUGH THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY WAS VERY NARROW AND TORTUOUS. THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS FULLY DEPLOYED AND A TOUCH-UP WAS PERFORMED. THEN, CANNULATION FROM THE LEFT SIDE TO THE RIGHT COMMON ILIAC ARTERY WAS ATTEMPTED, BUT IT COULD NOT BE ADVANCED THROUGH THE RIGHT COMMON ILIAC ARTERY. AFTER SEVERAL ATTEMPTS, ANGIOGRAPHY WAS PERFORMED, REVEALING THAT THE RIGHT COMMON ILIAC ARTERY WAS COMPLETELY OCCLUDED. THE PROCEDURE WAS CONVERTED TO AN AORTOUNILIAC (AUI) PROCEDURE WITH A FEMORAL-FEMORAL ARTERY BYPASS. A

  Patient problems: Embolism/Embolus

  MAUDE report 23861666 ↗
• MalfunctionDec 22, 2025Break; Break

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, A 16 FR DSF SHEATH WAS REMOVED AND A PERCLOSE DEVICE WAS USED FOR CLOSURE OF THE PUNCTURE SITE, BUT THE DEVICE DID NOT WORK PROPERLY, REQUIRING CONVERSION TO CUT-DOWN FOR HEMOSTASIS. THE REMOVED DSF SHEATH WAS THEN REINSERTED FOR APPROXIMATELY 8 CM. DURING REINSERTION, IT WAS OBSERVED THAT A BLACK WIRE (COIL) WAS PROTRUDING FROM THE SHEATH TUBE AT 10 CM FROM THE SHEATH TIP. THIS PORTION HAD NOT ENTERED THE PATIENT¿S BODY, SO THE CUT-DOWN AND HEMOSTASIS WAS NOT AFFECTED, AND THE PROCEDURE WAS CONCLUDED WITHOUT PATIENT¿S HEALTH INJURY. REPORTEDLY, PREPARATION OF THE DEVICES AND TECHNIQUE AT THE START OF PROCEDURE WERE WITHOUT ISSUES. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE TIMING OF THE SHEATH DAMAGE WAS UNKNOWN. DUE TO THE NARROW ACCESS, IF THE SHEATH HAD BEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861530 ↗
• InjuryNov 26, 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, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR STENOSIS AT THE ANASTOMOSIS OF A Y GRAFT REPLACEMENT FOR THE ABDOMINAL AORTA USING A NON-GORE GRAFT AT THE LEFT COMMON ILIAC ARTERY (SUSPECTED PSEUDOANEURYSM). GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE USED FOR THIS EVAR PROCEDURE. A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE AND A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH FROM THE RIGHT SIDE, THEN ALL DEVICES WERE IMPLANTED. IT WAS REPORTED THAT THE 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE AFTER CLAMPING THE RIGHT FEMORAL ARTERY TO PREVENT THROMBOTIC OCCLUSION OF THE PERIPHERAL ARTERY. AFTER STENT GRAFTS WERE IMPLANTED, DOPPLER EXAMINATION REVEALED POOR BLOOD FLOW IN THE RIGHT PERIPHERAL ARTERY. ANGIOGRAPHY SHOWED STENOSIS/OCCLUSION NEAR THE POPLITEAL ARTERY. THROMBECTOMY USING A FOGARTY CATHETER WAS PERFORMED. IT WAS REPORTED THAT THROMBI WERE OBSERVED FROM THE INFRARENAL AORTA TO THE PERIPHERAL ARTERIES. THE PHYSICIAN STATED THAT THE RIGHT FEMORAL ARTERY WAS CLAMPED TO PREVENT THROMBOTIC OCCLUSION OF THE PERIP

  Patient problems: Embolism/Embolus

  MAUDE report 23663159 ↗
• InjuryNov 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 AN ENDOVASCULAR TREATMENT FOR PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE USED DEVICES OTHER THAN TAMBE ARE LISTED BELOW: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS: 6 COMPONENTS IN TOTAL, GORE® EXCLUDER® AAA ENDOPROSTHESIS: ONE CONTRALATERAL LEG, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE): ONE ILIAC BRANCH COMPONENT, GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), GORE® TRI LUMEN CATHETER, GORE® MOLDING & OCCLUSION BALLOON CATHETER. DURING THE PROCEDURE, INSERTION OF A 22FR DSF VIA THE LEFT FEMORAL ARTERY WAS ATTEMPTED BUT WAS DIFFICULT TO ADVANCE DUE TO CALCIFICATION. THE SHEATH WAS EXCHANGED FOR A 16FR DSF, BUT SIMILAR RESISTANCE WAS ENCOUNTERED. AFTER GUIDEWIRE EXCHANGE, BOTH 16FR AND 22FR DFSS WERE ADVANCED WITH RESISTANCE BUT SUCCESSFULLY INSERTED. WHILE POSITIONING THE AORTIC COMPONENT, WIRE WRAP OCCURRED AND WAS RESOLVED BY ROTATING THE GUIDEWIRE 360 DEGREES. THE AORTIC COMPONENT WAS DEPLOYED WITHOUT ISSUE. CANNULATION OF THE LEFT RENAL ARTERY WAS CHALLENGING, BUT AFTER GUIDEWIRE EXCHANGE, THE BRANCH COMPONENT

  Patient problems: Embolism/Embolus; Renal Impairment

  MAUDE report 23591289 ↗
• InjuryNov 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(4) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS AND GORE EXCLUDER AAA ENDOPROSTHESES, AND GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. FOLLOWING DEPLOYMENT OF THE TRUNK IPSILATERAL LEG JUST BELOW THE RENAL ARTERIES, A NON-GORE BALLOON WAS INFLATED, RESULTING IN COVERAGE OF THE LEFT RENAL ARTERY. ALTHOUGH CANNULATION OF THE RENAL ARTERY WAS NOT POSSIBLE, NO IMPAIRMENT OF RENAL BLOOD FLOW WAS OBSERVED. ADDITIONALLY, A MILD DISSECTION WAS OBSERVED NEAR THE DISTAL PORTION OF THE RIGHT COMMON ILIAC ARTERY. THE PATIENT WAS PLACED UNDER OBSERVATION WITHOUT ANY SPECIFIC INTERVENTION. THE DISSECTION MAY HAVE OCCURRED DURING ADVANCEMENT OF THE SHEATH (DSF1633) OR DURING BALLOONING OF THE CONTRALATERAL LEG (PLC231000J); HOWEVER, THE EXACT CAUSE REMAINS UNKNOWN. THE PHYSICIAN¿S COMMENT: ¿THE MAIN TRUNK MAY HAVE BEEN DEPLOYED TOO PROXIMALLY. I BELIEVED THAT THE RENAL ARTERY WAS NOT COVERED INTRAOPERATIVELY.¿

  Patient problems: Vascular Dissection

  MAUDE report 23473692 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS ACCESSORIES. 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 HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420073 ↗
• InjuryAug 8, 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 AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). A 16 FR DSF SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, BUT IT GOT STUCK AT THE PUNCTURE SITE. BALLOONING WAS PERFORMED FOR THE PUNCTURE SITE AND THEN, THE DILATOR WAS INSERTED ALONE. THERE WAS RESISTANCE WHEN INSERTING THE DILATOR. AFTER THAT, THE DSF SHEATH WAS INSERTED WITH THE DILATOR. ON THE LEFT SIDE, A 14 FR DSF SHEATH WAS ALSO DIFFICULT TO BE INSERTED (FELT RESISTANCE) BUT IT WAS INSERTED SUCCESSFULLY. THE ENDOPROSTHESES WERE IMPLANTED SUCCESSFULLY. AN ANGIOGRAPHY SHOWED THAT BLOOD FLOW IN THE RIGHT SIDE FROM THE FLOW DIVIDER DISAPPEARED. IT WAS BELIEVED DUE TO VASCULAR INJURY (INTIMA INJURY), SO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADDITIONALLY IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE BLOOD FLOW WAS RESTORED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: IT HAD BEEN KNOWN IN ADVANCE THAT INSERTION OF THE SHEATH INTO TH

  Patient problems: Perforation of Vessels

  MAUDE report 22746627 ↗
• InjuryAug 6, 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 AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). WHEN ADVANCING A 16 FR DSF SHEATH, IT GOT STUCK AT DISTAL COMMON ILIAC ARTERY WHERE SEVERE CALCIFICATION WAS NOTED AND VESSEL DIAMETER WAS APPROXIMATELY 7 MM. THE PHYSICIAN PERFORMED BALLOONING FOR THIS SITE AND THEN, THE DSF SHEATH WAS SUCCESSFULLY ADVANCED TO THE TARGET SITE. THE FINAL ANGIOGRAPHY SHOWED VASCULAR DISSECTION ON THE DISTAL COMMON ILIAC ARTERY WHERE THE DSF SHEATH GOT STUCK. MOST OF THE DISSECTION WAS FOUND WITHIN THE TREATMENT AREA OF THE RIGHT CONTRALATERAL LEG, SO THE PHYSICIAN ONLY PERFORMED BALLOONING FOR THE CONTRALATERAL LEG AND NO ADDITIONAL DEVICE WAS NEEDED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PATIENT¿S CALCIFICATION WAS SEVERE AND THE DISSECTION WAS CONSIDERED UNAVOIDABLE.

  Patient problems: Vascular Dissection

  MAUDE report 22724040 ↗

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.