GORE DRYSEAL FLEX Introducer Sheath DSF1433Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00733132630004), received between Oct 3, 2018 and Sep 28, 2026 — classified as 3 deaths, 25 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore:On (b)(6), 2026, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm. A GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System and four GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were implanted using two GORE® DrySeal Flex Introducer Sheath (22Fr and 14Fr), a GORE® Tri Lumen Catheter and a GORE® Molding & Occlusion Balloon Catheter.The 22Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left femoral artery, and the 14Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left axillary artery.After implantation of all devices, angiography revealed a rupture and dissection extending from the left external iliac artery to the left common femoral artery. A GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and a GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface were implanted in the left external iliac artery to treat the rupture. Subsequently, the 22 Fr GORE® DrySeal Flex Introducer Sheath inadvertently backed out. Two additional GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were imp

  Patient problems: Embolism/Embolus; Ischemia

  MAUDE report 50911724 ↗
• 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 25326085 ↗
• MalfunctionApr 17, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907684 ↗
• InjuryMar 25, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. WHILE ADVANCING THE DEVICE, A PERFORATION IN THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED.THE PERFORATION WAS TREATED SURGICALLY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE VESSEL DIAMETER WAS SUFFICIENT, BUT A RESISTANCE WAS FELT.

  Patient problems: Perforation of Vessels

  MAUDE report 24684020 ↗
• 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 22216893 ↗
• InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE WERE IDENTIFIED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. FOR THE PROXIMAL TYPE I ENDOLEAK, THREE AORTIC EXTENDER ENDOPROSTHESIS WERE IMPLANTED PROXIMALLY WITH THE RIGHT FEMORAL ARTERY APPROACH. FOR THE LEFT DISTAL TYPE I ENDOLEAK, USING A 14FR SHEATH, WITH THE LEFT FEMORAL ARTERY APPROACH, TWO CONTRALATERAL LEG ENDOPROSTHESIS WERE IMPLANTED OVER THE LEFT EXTERNAL ILIAC ARTERY AFTER COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY. (THIS EVENT IS CAPTURED IN: REPORT# 3007284313-2025-03864 AND 3013164176-2025-02454.) FINAL ANGIOGRAPHY REVEALED DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY NEAR THE DISTAL END OF THE CONTRALATERAL LEG ENDOPROSTHESIS. THE DISSECTION WAS DECIDED TO MONITROR AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTEDLY STATED AS FOLLOWS: AS FOR THE DISSECTION, AS THE BLOOD FLOW WAS NOT

  Patient problems: Vascular Dissection

  MAUDE report 21734735 ↗
• DeathDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2024, THE PATIENT WAS BEING TREATED FOR A LARGE SYMPTOMATIC LEFT COMMON ILIAC ARTERY ANEURYSM. IT WAS REPORTED THAT DURING ACCESS THE PHYSICIAN WAS HAVING ISSUES WITH THE WIRE BECOMING COILED. DURING THIS TIME THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) HAD NOTED THAT THE PATIENTS BLOOD PRESSURE WAS LOW. REPORTEDLY THE BLOOD PRESSURE WAS LOW DURING ACCESS. THE PHYSICIAN OBTAINED BILATERAL (LEFT AND RIGHT) COMMON FEMORAL ARTERY (CFA) ACCESS AND PLACED A MEDTRONIC MVP 9Q INTO THE LEFT INTERNAL ILIAC ARTERY VIA THE RIGHT CFA ACCESS. NEXT, HE PLACED AN AMPLATZ WIRE INTO THE AORTA VIA THE LEFT CFA ACCESS WITH A 5FR 65CM GLIDECATH. THIS WIRE AND CATHETER BECAME COILED IN THE 4.6CM COMMON ILIAC ARTERY. IT HAD BEEN DETERMINED THAT THE LEFT COMMON ILIAC ANEURYSM HAD RUPTURED. THE PHYSICIAN INSERTED AN OCCLUSION BALLOON IN THE DISTAL AORTA THROUGH THE RIGHT CFA ACCESS. THE PATIENT DID NOT STABILIZE, AND BLOOD WAS ORDERED. A GORE® DRYSEAL SHEATH WAS ADVANCED AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE WAS IMPLANTED BUT WAS NOT LONG ENOUGH TO COVER THE RUPTURED LEFT COMMON ILIAC ARTERY. WIRE ACCESS WAS LOST AND THE P

  Patient problems: Ruptured Aneurysm

  MAUDE report 20860196 ↗
• InjuryDec 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. THE CONTRALATERAL LEG COMPONENT OF GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS LANDED ITS DISTAL END ON THE LEFT AND RIGHT COMMON ILIAC ARTERIES EACH. FINAL ANGIOGRAPHY SHOWED DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY. AN ADDITIONAL STENT WAS IMPLANTED AS A TREATMENT. THE PHYSICIAN MENTIONED THAT IT WAS UNCLEAR WHEN THE DISSECTION OCCURRED. REPORTEDLY THERE WAS NO RESISTANCE DURING THE SHEATH INSERTION.

  Patient problems: Vascular Dissection

  MAUDE report 20849841 ↗
• InjuryNov 21, 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. REPORTEDLY, A 14FR DSF SHEATH WAS INTRODUCED FROM RIGHT SIDE AT THE FIRST, AND THEN THE SHEATH WAS CHANGED TO A 16FR DSF SHEATH. AFTER HEMOSTASIS OF THE PUNCTURE SITE, IT WAS NOTICED THAT THE RIGHT DORSALIS PEDIS ARTERY PULSE COULD NOT BE CONFIRMED. AN ANGIOGRAPHY IMAGING REVEALED A DISSECTION IN THE RIGHT COMMON FEMORAL ARTERY. THE DISSECTION WAS TREATED BY SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT IT IS UNKNOWN WHEN THE DISSECTION WAS FORMED BUT IT WAS PROBABLY FORMED DURING SHEATH INSERTION.

  Patient problems: Vascular Dissection

  MAUDE report 20742747 ↗
• MalfunctionOct 31, 2024Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER ADVANCING THE 14FR SHEATH FROM THE LEFT SUBCLAVIAN ARTERY TO THE ASCENDING AORTA, A CONTRAST IMAGING REVEALED CONTRAST MEDIUM LEAKING APPROXIMATELY 5CM FROM THE DEVICE¿S TIP. A TEAR WAS OBSERVED ABOUT 5CM FROM THE SHEATH TIP AFTER REMOVING IT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING AN ALTERNATIVE SHEATH. THE DEVICE WAS SENT BACK TO US GORE FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578892 ↗
• InjurySep 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS. FINAL ANGIOGRAPHY AFTER STENT GRAFT PLACEMENT CONFIRMED A LOCALIZED DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DECIDED TO BE MONITORED. THE PHYSICIAN MENTIONED THAT THE DISSECTION MAY HAVE OCCURRED DURING BALLOON TOUCH-UP. THE LOCALIZED DISSECTION WAS LOCATED IN DISTAL FROM THE SITE OF STENT GRAFT PLACEMENT. IT WAS REPORTED THAT BALLOON TOUCH-UP BY A NON-GORE DEVICE MAY HAVE DONE OUTSIDE THE STENT GRAFT. THERE WAS CALCIFICATION IN THE PATIENT'S ACCESS VESSEL. THE SHEATH INSERTION COULD NOT BE ALSO RULED OUT IN FORMATION OF THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 20253484 ↗
• InjuryJul 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK TREATMENT OF A THORACIC ARCH ANEURYSM. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE THORACIC ARCH ANEURYSM USING ZENITH ALPHA DEVICE. ON THE SAME DAY, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING ENDURANT AORTA EXTENSION, GORE® EXCLUDER® AAA ENDOPROSTHESES, AND THREE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). TWO 16 FR DSF DEVICES WERE USED FOR BILATERAL ACCESSES, DSF1633/ (B)(6) WAS IN THE RIGHT ACCESS AND DSF1633/ (B)(6) WAS IN THE LEFT ACCESS. ONE 14 FR DSF WAS SWITCHED FOR A CONTRALATERAL LEG COMPONENT IN THE LEFT ACCESS. AFTER ALL STENT GRAFTS WERE IMPLANTED, A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED. ADDITIONALLY BARE METAL STENT (E-LUMINEXX 12 MM - 6 CM) WAS IMPLANTED. INTIMAL DAMAGES WERE OBSERVED AT BILATERAL INSERTION SITES AND SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 19789901 ↗
• InjuryJun 12, 2024Adverse 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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). TWO GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS READMITTED TO HOSPITAL FOR SURGICAL SITE INFECTION AND INFECTED HEMATOMA IN BILATERAL GROIN. PATIENT TREATED AT HOSPITAL WITH ANTIBIOTICS.

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

  MAUDE report 19522338 ↗
• InjuryJun 12, 2024Adverse 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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). TWO GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS READMITTED TO HOSPITAL FOR SURGICAL SITE INFECTION AND INFECTED HEMATOMA IN BILATERAL GROIN. PATIENT WAS TREATED AT HOSPITAL WITH ANTIBIOTICS.

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

  MAUDE report 19522308 ↗
• InjuryFeb 20, 2024Difficult to Remove; Patient-Device Incompatibility; Difficult to Remove; Patient-Device Incompatibility

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR A TREATMENT OF SYMPTOMATIC INFERIOR VENA CAVA OBSTRUCTIONS USING GORE® VIAFORT VASCULAR STENTS. A GORE® DRYSEAL SHEATH (DSF1433/(B)(6)) WAS USED FOR ACCESS. REPORTEDLY, DURING THE PROCEDURE, THE STENT (VNS240702C/(B)(6)) WOULD NOT ADVANCE OUT OF THE SHEATH. THE DEVICE GOT STUCK IN THE EXTERNAL ILIAC VEIN AS IT EXITED THE SHEATH. ALSO, THE PHYSICIAN WAS NOT ABLE TO WITHDRAW THE DEVICE FROM THE PATIENT. THE PHYSICIAN PULLED THE DEVICE WITH THE SHEATH BACK. REPORTEDLY, THE PHYSICIAN DID NOT FEEL ANY RESISTANCE ON SHEATH IN OR OUT. THE DIFFICULTY TO PULL THE SHEATH BACK FROM THE PATIENT WAS DUE TO THE LONG-STANDING CHRONIC THROMBUS. REPORTEDLY, THE SMALL SKIN CUT DOWN WAS MADE AS AN EMERGENCY, BECAUSE THE PHYSICIAN COULDN'T WITHDRAW THE DEVICE WITHOUT BETTER CONTROL AT THE LEVEL OF THE VEIN. REPORTEDLY, THE SHEATH SIZE WAS ACCORDING TO THE IFU. THE ACCESS VESSEL WAS 12MM. REPORTEDLY, VESSELS WERE NOT DAMAGED. THE PHYSICIAN NOTICED SOME DAMAGE ON THE TIP OF THE SHEATH AS THEY TRIED TO PULL THE DEVICE BACK INTO IT. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS

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

  MAUDE report 18741134 ↗
• MalfunctionDec 11, 2023Material Perforation; Insufficient Device Problem Information; Material Perforation; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. AFTER INSERTION INTO THE PATIENT BODY, A FLUOROSCOPIC IMAGING REVEALED AN ABNORMALITY IN THE DEVICE. THE DEVICE WAS REMOVED AND DAMAGE TO THE SHEATH TUBE WAS OBSERVED. ANOTHER NEW DEVICE WAS USED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307010 ↗
• InjuryOct 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) FOR ABDOMINAL AORTIC ANEURYSM. THE DSF WERE INSERTED AFTER USAGE OF NON-GORE DEVICE (PERCLOSE). AFTER ALL STENT-GRAFT PLACEMENTS, IT WAS CONFIRMED THAT BLOOD FLOW TO BOTH LOWER EXTREMITIES WAS WEAK WHEN PERFORMING HEMOSTASIS. WHEN BOTH SIDES WERE CUT DOWN AND VASCULAR EVALUATION WAS PERFORMED, RUPTURE WAS CONFIRMED IN THE FEMORAL ARTERY. SURGICAL REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THE FOLLOWING. THE RUPTURE WAS CAUSED BY EITHER THE PERCLOSE OR DSF, BUT IT IS UNCLEAR WHICH ONE CONTRIBUTED TO THE EVENT. BECAUSE THE PATIENT WAS ELDERLY, HIS BLOOD VESSELS WERE WEAK.

  Patient problems: Perforation of Vessels

  MAUDE report 17993406 ↗
• DeathApr 12, 2023Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK OCCURRING AFTER A PLACEMENT OF NON GORE STENTGRAFT (AFX ENDOVASCULAR AAA SYSTEM) . FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED BELOW THE RENAL ARTERIES, TO THE RIGHT AND LEFT COMMON ILIAC ARTERIES. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT WAS UNABLE TO MOVE BOTH LEGS. PARAPLEGIA WAS OBSERVED AND SPINAL DRAINAGE WAS PERFORMED. THE PATIENT IS BEING MONITORED. REPORTEDLY THE PATIENT HAD SHAGGY THORACIC AORTA. THE PHYSICIAN REPORTED THAT THROMBUS MIGHT HAD SHIFTED TO THE INTERCOSTAL ARTERY OR COMMON CAROTID ARTERY DUE TO GUIDEWIRE MANIPULATION. ON JANUARY 27, 2023 ADDITIONAL INFORMATION RECEIVED FROM GORE FSA. DURING REINTERVENTION ON (B)(6) WHEN THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1433/(B)(4)) WAS INSERTED TO THE PATIENT, IT CAUGHT ON INNER SKELETON (STENT SKELETON PLACED INSIDE OF GRAFT) OF AN IMPLANTED NON GORE STENTGRAFT (AFX), CAUSING MIGRATION OF THE NON GORE STENTGRAFT TO THE PROXIMAL SIDE. IT RESULTED IN A TYPE IB ENDOLEAK WITH ANEURYSM RUPTURE, AND BLOOD LOSS DURING REINTERVENTION. THE PROCEDURE WAS COMPLETED WIT

  Patient problems: Ruptured Aneurysm

  MAUDE report 16722176 ↗
• InjuryNov 11, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 51MM WITH A GORE®EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1433/ (B)(4) WAS USED FOR ACCESS AT THE RIGHT FEMORAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, A RIGHT FEMORAL ARTERY PSEUDOANEURYSM WAS DETERMINED. NO TREATMENT WAS REQUIRED. THE EVENT WAS ONGOING. THE PHYSICIAN WAS MONITORING THE PATIENT. FOLLOW UP CT SCANS FROM (B)(6) 2019 TILL (B)(6) 2022, SHOWED THAT THE MAXIMUM ABDOMINAL AORTIC ANEURYSM DIAMETER DECREASED IN SIZE FROM 56MM TO 52MM. FOLLOW UP ON (B)(6) 2020, SHOWED THAT THE MAXIMUM ABDOMINAL AORTIC ANEURYSM DIAMETER WAS 57MM. ON (B)(6) 2019, A RIGHT COMMON ILIAC ARTERY PSEUDOANEURYSM WAS DETERMINED. NO TREATMENT WAS REQUIRED. THE EVENT IS ONGOING. THE PHYSICIAN WAS MONITORING THE PATIENT. ON (B)(6) , 2022, THE ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE THAT THE PHYSICIAN BELIEVES THAT A RIGHT FEMORAL ARTERY PSEUDOANEURYSM WAS CAUSED DURING THE VESSEL BEING ACCESSED DURING THE IMPLANT PROCEDURE ON (B)(6) 2018. WHEN REVIEWING THE CT SCANS, THE PHYSICIAN DID NOT SEE A RIGHT

  Patient problems: Aneurysm; Pseudoaneurysm; Vascular Dissection

  MAUDE report 15785347 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS RECEIVED FROM THE FDA (MW5111554). AS REPORTED, DURING AN AORTA ILIAC MECHANICAL THROMBECTOMY ON (B)(6) 2022, A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED TO THE PATIENT'S RIGHT FEMORAL ARTERY. IT WAS REPORTED BY THE PHYSICIAN THAT, DURING MANIPULATION AND RETRACTION ON THE SHEATH THE TIP OF THE SHEATH BROKE OFF INSIDE PATIENT'S ARTERY. AS REPORTED, SEVERAL ATTEMPTS WERE MADE IN AN EFFORT TO RETRIEVE THE PROXIMAL TIP: TRYING TO THREAD A WIRE AND USING A SNARE TO REMOVE IT. HOWEVER, THESE ATTEMPTS WERE NOT SUCCESSFUL IN REMOVING THE TIP OF THIS SHEATH FROM THE PATIENT. AS REPORTED BY THE PHYSICIAN, THE ATTEMPT TO RETRIEVE THE SHEATH TIP WAS DISCONTINUED AS IT WAS PERCEIVED TO BE UNSAFE AND OF NO MEDICAL BENEFIT AS THE "GIVEN THE FACT THAT THE PATIENT STILL DID NOT HAVE PAIN AND CT THROUGH HIS AORTA AND KNOWING THAT HIS ENDOGRAFT WOULD BE OCCLUDED STILL.". REPORTEDLY THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. REPORTEDLY THERE WAS NO IDENTIFIED ARTERIAL DAMAGE OR PERFORATION. IT WAS REQUESTED BUT NOT INDICATED IF THERE WAS ANY HEMODYNAMIC IMPAIRMENT (E.G. TACHYCARDIA, HYPOTENSION, ¿CODING¿ OR CARDIOPULMONARY RESUSCITATION, ETC.) RESULTING FROM AN

  Patient problems: Foreign Body In Patient

  MAUDE report 15513656 ↗
• InjuryAug 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY FROM LEFT-SIDED ACCESS. HOWEVER, CANNULATION INTO THE LEFT INTERNAL ILIAC ARTERY WAS REPORTEDLY UNSUCCESSFUL. THE PATIENT¿S RIGHT SIDE WAS ACCESSED, AND THE LEFT INTERNAL ILIAC ARTERY WAS SUCCESSFULLY EMBOLIZED. A 14 FR DSF WAS THEN INSERTED FROM THE LEFT SIDE. ACCORDING TO THE REPORT, THE PATIENT¿S VASCULATURE WAS EXTREMELY TORTUOUS. WHILE ADVANCING THE DSF THROUGH LEFT EXTERNAL ILIAC ARTERY, A MARKED DECREASE IN BLOOD PRESSURE WAS NOTED, AND THE DSF WAS REPORTEDLY OUTSIDE THE VESSEL. THE PHYSICIAN ADVANCED AND INFLATED A MOLDING AND OCCLUSION BALLOON (MOB) FROM THE LEFT SIDE TO BLOCK BLOOD FLOW AT THE COMMON ILIAC ARTERY. ANOTHER MOB WAS ADVANCED FROM THE RIGHT SIDE AND INFLATED TO BLOCK BLOOD FLOW AT THE DISTAL AORTA. THE FIRST MOB WAS THEN DEFLATED, AND THREE STENT GRAFTS WERE IMPLANTED AS TREATMENT FROM THE LEFT EXTERNAL ILIAC ARTERY TO THE MIDDLE OF THE LEFT COMMON ILIAC ARTERY ANEURYSM. THE PROCEDURE WENT

  Patient problems: Perforation of Vessels

  MAUDE report 15266345 ↗
• InjuryAug 17, 2022Break

  DURING AORTA ILIAC MECHANICAL THROMBECTOMY A DRYSEAL FLEXSHEATH DEVICE WAS INTRODUCED TO PATIENT'S RIGHT FEMORAL ARTERY. DURING MANIPULATION SHEATH BROKE INSIDE PATIENT'S ARTERY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15249604 ↗
• MalfunctionAug 4, 2022Break; Material Deformation; Break; Material Deformation

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) AS AN ACCESSORY IN THE PROCEDURE. A PULL-THROUGH GUIDEWIRE WAS CREATED WITH LEFT FEMORAL ARTERY TO LEFT RADIAL ARTERY, AND THE DSF SHEATH WAS INSERTED THROUGH THE LEFT FEMORAL ARTERY. REPORTEDLY, THE TORTUOSITY AT THE LEFT EXTERNAL ARTERY AND THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY MADE IT DIFFICULT TO ADVANCE THE DSF SHEATH. AFTER INSERTION OF THE DSF SHEATH, IT WAS OBSERVED THAT THE DSF SHEATH WAS KINKED DUE TO THE TORTUOSITY OF THE LEFT ILIAC EXTERNAL ARTERY WHEN THE CONTRALATERAL LEG DEVICE WAS INSERTED. AFTER THE CONTRALATERAL LEG DEVICE WAS DELIVERED TO THE TARGET SITE, THE PHYSICIAN ATTEMPTED TO REMOVE THE DSF SHEATH, AND THE PHYSICIAN HEARD A STRANGE NOISE, BUT COULD NOT FIGURE OUT THE CAUSE, SO THE PHYSICIAN CONTINUED TO REMOVE THE DSF SHEATH. AND THEN IT WAS CONFIRMED THAT THE DSF SHEATH WAS TORN, AND ONLY THE PROXIMAL PART OF THE SHEATH WAS PULLED OUT. THE TORN PART DID NOT PULLED DOWN AND THE STENT GRAFT WAS STILL INSIDE THE TORN PART. SO THE TORN PART REMOVED FROM THE PATIENT A

  Patient problems: Aneurysm

  MAUDE report 15171510 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES (AAA) AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSFS). THIS PATIENT ALSO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION USING A SAPIEN SIMULTANEOUSLY. DURING PROCEDURE, WHILE A MOB BALLOON WAS INFLATED INSIDE A CONTRALATERAL LEG COMPONENT IN THE LEFT SIDE, THE CONTRALATERAL LEG MIGRATED PROXIMALLY (INTO THE ANEURYSMAL SAC). DUE TO THIS MIGRATION, THE DISTAL LANDING ZONE WAS INSUFFICIENT AND THEREFORE, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED. AFTER ALL THE STENT GRAFTS WERE DEPLOYED, A DISSECTION WAS OBSERVED DURING ANGIOGRAPHY FOR THE LEFT ACCESS VESSELS, BUT NO TREATMENT WAS GIVEN AND SURGICAL INCISION IN THE LEFT COMMON FEMORAL ARTERY WAS CLOSED. AFTERWARDS, AN ECHOGRAPHY SHOWED NO BLOOD FLOW IN THE POSTERIOR TIBIAL ARTERY AND AN ANGIOGRAPHY WAS PERFORMED AGAIN. IT SHOWED BLOOD FLOW DISSIPATING IN THE LEFT EXTERNAL ILIAC ARTERY. REPORTEDLY, THIS MIGHT HAVE BEEN DUE TO A KINK OF THE BLOOD VESSEL. AN ACCESS ROUTE WAS SECURED FROM THE RADIAL ARTERY AND A BARE-METAL STENT (SMART, 10 MM X 60 MM) WAS PLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957375 ↗
• MalfunctionDec 22, 2021Sharp Edges; Sharp Edges

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DSFS). PATIENT¿S PRE-OPERATIVE MEDICAL HISTORY INCLUDED RIGHT UNILATERAL NEPHRECTOMY. THE IMPLANTATION OF DEVICES WAS COMPLETED WITHOUT ANY PROBLEMS. AFTER THE PHYSICIAN REMOVED A DSF1433 FROM THE PATIENT, HE ATTEMPTED TO CLOSE THE RIGHT ACCESS SITE USING PERCLOSE PROGLIDES; HOWEVER, BLEEDING FROM THE RIGHT FEMORAL ARTERY DID NOT STOP. VITAL SIGNS DID NOT CHANGE. THE PHYSICIAN PRESSURIZED THE SITE TO STOP BLEEDING AND THE DSF1433 WAS INSERTED AGAIN. A SURGICAL REPAIR WAS PERFORMED TO CLOSE THE ACCESS SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: WHEN THE DSF1433 WAS REMOVED, A TORN WAS NOTED ON THE SHEATH. A SUTURE OF THE PERCLOSE WAS POSSIBLY CAUGHT IN THE TORN OF THE SHEATH EDGE AND CUT. THIS MIGHT HAVE BEEN CAUSED BECAUSE OF UNIDEAL INSERTION ANGLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13063722 ↗

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.