GORE EXCLUDER AAA Endoprosthesis with C3 DeliveryRecalls & reported problems across all models

We found 51 models of GORE EXCLUDER AAA Endoprosthesis with C3 Delivery by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 988 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Sep 28, 2026 — classified as 50 deaths, 828 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (174 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE EXCLUDER AAA Endoprosthesis with C3 Delivery problems

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery models

51 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths73 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths72 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311413

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 deaths68 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths62 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 deaths60 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311417

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death48 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  47 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths43 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death38 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths36 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths35 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death32 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths29 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death22 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death14 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths11 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  11 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death10 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  10 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  9 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  9 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths8 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death8 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death5 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311413

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311417

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE EXCLUDER AAA Endoprosthesis with C3 Delivery adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Failure to Seal

  Patient problems: Clinical Endoleak

  MAUDE report 50918116 ↗
• InjuryAug 7, 2026Malposition of Device; Migration

  It was reported to Gore that, on (b)(6) 2026, a GORE® EXCLUDER® AAA Endoprosthesis was used for an endovascular aneurysm repair (EVAR). During preparation for introduction of the iliac component on the ipsilateral side, the 18 Fr GORE® DrySeal Flex Introducer Sheath was re-advanced and encountered some resistance. The clinician pushed the sheath past the resistance, causing proximal migration of the GORE® EXCLUDER® AAA Endoprosthesis trunk, resulting in coverage of the renal arteries. A chimney procedure was subsequently performed without complications and blood flow to both renal arteries was maintained. The patient tolerated the procedure.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 50170368 ↗
• InjuryJun 25, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6), 2015, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO A TYPE 1A ENDOLEAK. AN AORTIC EXTENDER WAS USED TO RESOLVE THE LEAK. IT WAS NOTED THAT THE PATIENT HAD PREVIOUS ENDOVASCULAR PROCEDURES IN 2015 AND 2020.

  Patient problems: Clinical Endoleak

  MAUDE report 25621389 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2026, A FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED OF A POTENTIAL NEED FOR REINTERVENTION FOLLOWING CTA IMAGING (DATE UNKNOWN) THAT DEMONSTRATED CONTRAST WITHIN THE ANEURYSM SAC, RAISING CONCERN FOR A SUSPECTED TYPE III ENDOLEAK. ANEURYSM SAC GROWTH WAS NOT NOTED WITH NO SIZE REPORTED ON IMAGING. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION. THE INTERVENTION TARGETED THE RIGHT (IPSILATERAL) SIDE OF THE MAIN BODY GRAFT RATHER THAN A COMPONENT JUNCTION. IT WAS REPORTED THAT THE PHYSICIAN ELECTED TO RELINE THIS SEGMENT USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC161200) TO ADDRESS THE SUSPECTED TYPE III ENDOLEAK. NO ENDOLEAK WAS IDENTIFIED ON INTRA-PROCEDURAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATION. ON (B)(6) 2026, FSA RECEIVED ADDITIONAL INFORMATION FROM THE PHYSICIAN THAT THE ENDOLEAK WAS INDETERMINATE AND THOUGHT TO BE TYPE 2 AT THE END BUT PHYSICIAN CHOSE TO REINTERVENE AND REPAIRED USING ADDITIONAL STENT BECAUSE IT HAD BEEN REPORTED AS TYPE 3 ENDOL

  Patient problems: Clinical Endoleak

  MAUDE report 25594054 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED AFTER THE IMPLANT PROCEDURE; THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS AND THAT PROGRESSED INTO LOWER EXTREMITY PARALYSIS. THERE WAS NO INTERVENTION, THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TO TREAT THE NEUROLOGICAL DEFICIT. REPORTEDLY A SPINAL DRAIN WAS PLACED PRE-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Paralysis

  MAUDE report 25448276 ↗
• InjuryMay 28, 2026No Apparent Adverse Event

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION AND A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO EXTEND COVERAGE PROXIMALLY. IT WAS REPORTED THAT WHEN THE TECH WAS SLIPPING THE PLASTIC TUBE OFF, IT LOOKED LIKE THE STENT MOVED PROXIMAL ON THE CATHETER AND THE LINE SEEMED TO BREAK. ANOTHER GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS PREPPED AND IMPLANTED IN IT¿S PLACE. THE PATIENT TOLERATED THE PROCEDURE. THE FIRST DEVICE WAS NOT USED AND WAS DISCARDED AT THE SITE AND NOT AVAILABLE FOR EVALUATION BY GORE.

  Patient problems: Aneurysm

  MAUDE report 25325444 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2026, POST PROCEDURE IMAGES REVEALED TWO DISTAL ENDOLEAKS AND A TYPE III ENDOLEAK. THERE WAS A REINTERVENTION.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25237010 ↗
• InjuryMay 13, 2026Migration

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF FOR AN UNKNOWN ETIOLOGY AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY WHICH DETERMINED DISTAL MIGRATION OF THE DEVICES (DISTANCE UNKNOWN). ON (B)(6) 2026 THE PATIENT UNDERSENT REINTERVENTION AND TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER DEVICES AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE IMPLANTED ALONG WITH ENDO ANCHORS TO RESTORE COVERAGE UP TO THE RENAL ARTERIES. THE DEVICE MIGRATION IS ATTRIBUTED TO DISEASE PROGRESSION AND THROMBUS IDENTIED BY THE IMAGES PROVIDED. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 25165299 ↗
• MalfunctionMay 13, 2026Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: (DATE: (B)(6) 2026), THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH C3® DELIVERY SYSTEM (EXCLUDER DEVICE). THE DEVICE WAS DELIVERED TO THE TARGET LESION THROUGH DSF1833 INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS WITHDRAWN TO THE DISTAL END OF THE ENDO. THE DEPLOYMENT KNOB OF EXCLUDER DEVICE WAS ROTATED AND PULLED TO DEPLOY THE DEVICE. THE WHITE DEPLOYMENT LINE ON THE KNOB WAS PULLED OUT OF THE CATHETER, AND IT WAS FOUND THAT THE PROXIMAL END OF THE ENDO WAS NOT FULLY EXPANDED. PHYSICIAN TURNED TO THE BACKUP DEPLOYMENT MECHANISM; BUT LINE 1 WAS NOT FOUND. THEREFORE, THE EXCLUDER DEVICE WAS WITHDRAWN INTO THE INTRODUCER SHEATH AND REMOVED COMPLETELY. ANOTHER EXCLUDER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE AND HAD NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157746 ↗
• InjuryMay 11, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, CT IMAGING DEMONSTRATED AN ENLARGING ANEURYSM SAC MEASURING APPROXIMATELY 5.3 × 5.9 CM WITH FINDINGS SUGGESTIVE OF A TYPE II ENDOLEAK. ON (B)(6) 2026, ANGIOGRAPHIC EVALUATION WAS PERFORMED TO FURTHER ASSESS AND POTENTIALLY TREAT THE SUSPECTED TYPE II ENDOLEAK. SELECTIVE CATHETERIZATION AND EMBOLIZATION WERE ATTEMPTED; HOWEVER, DEFINITIVE CATHETERIZATION WAS NOT ACHIEVED DUE TO VESSEL TORTUOSITY. NO EMBOLIZATION WAS PERFORMED, AND THE SUSPECTED ENDOLEAK PERSISTED. ON (B)(6) 2026, CT ANGIOGRAPHY CONFIRMED A TYPE II ENDOLEAK WITHIN THE DISTAL AORTIC SAC WITH ANEURYSM SAC ENLARGEMENT MEASURING APPROXIMATELY 6.2 CM. ON (B)(6) 2026, THE PATIENT UNDERWENT AN OPEN SURGICAL REPAIR OF THE ABDOMINAL AORTIC ANEURYSM WITH EXPLANTATION OF THE AORTIC ENDOGRAFT. OPERATIVE FINDINGS INCLUDED AN EXPANDING ANEURYSM WITH A TYPE II ENDOLEAK ATTRIBUTED TO BLEEDING LUMBAR ARTERIES. A MIDLINE LAPAROTOMY WAS PERFORMED WITH EXPOSURE OF THE INFRARENAL AORTA AND BILATERAL COMMON ILIAC ARTERIES. THE ANEURYSM SAC

  Patient problems: Aneurysm expansion; Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25137664 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE AAA24-01 TAMBE POST APPROVAL STUDY AND INFORMATION REGARDING THIS EVENT WAS GATHERED FROM THE IMEDIDATA CLINICAL DATABASE. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IV THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH A CONTAINED RUPTURE OF THE PERIVISCERAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2026, ENDOVASCULAR REPAIR OF THE LEFT COMMON ILIAC ARTERY ANEURYSM WITH A LEFT ILIAC EXTENSION INTO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED. THERE WAS AN AORTIC CUFF IMPLANTED AT THE DISTAL TO TAMBE AT THE JUNCTION WITH THE EXCLUDER BIFURCATING DEVICE TO OVERLAP THIS REGION TO PREVENT A POSSIBLE JUNCTIONAL ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY ON (B)(6) 2026 PATIENT DEVELOPED ACUTE KIDNEY FAILURE, THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 25048557 ↗
• InjuryApr 14, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A LEFT COMMON ILIAC ARTERY ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND AORTIC EXTENDER). REPORTEDLY, DURING DEVICE PREPARATION, THE SCRUB NURSE OPENED THE AORTIC EXTENDER DEVICE ONTO THE STERILE SETUP AND DURING THAT PREPARATION, FOUND A 1 - 1.5 CM SEPARATION OF THE STENT GRAFT FROM THE DELIVERY CATHETER ALBEIT STILL HELD ON BY A THREAD. NO DAMAGE WAS NOTED TO THE OLIVE TIP. THE YELLOW PACKING COVER OVER THE GRAFT WAS STILL IN SITU WHEN THIS WAS FOUND AND CONCERN WAS THAT THIS WOULD SNAP WITH THE REMOVAL OF THE YELLOW PROTECTIVE CAP ALONG WITH THAT THE GRAFT WOULD BE LOOSE ONCE THE YELLOW PROTECTIVE CAP WAS REMOVED. DEVICE WAS ASSUMED FAULTY AND THEREFORE NOT IMPLANTED AS PHYSICIAN SUSPECTED IT TO BE A MANUFACTURING FAULT. PATIENT WAS LEFT WITH THE TYPE 1A ENDOLEAK AND IS BEING BROUGHT BACK FOR REINTERVENTION PROCEDURE ON (B)(6) 2026 FOR INSERTION OF AN AORTIC EXTENDER AS NO SPARE DEVICE WAS AVAILABLE ONSITE DURING THE INITIAL PROCEDURE. ON (B)(6) 2026, PATIENT UNDERWENT SUCCESSFUL REINTERVENTION PROCEDURE TO TREAT THE TYPE 1A ENDOLEAK W

  Patient problems: Clinical Endoleak

  MAUDE report 24877089 ↗
• MalfunctionApr 3, 2026Difficult to Advance

  ON (B)(6) 2026, DURING AN ENDOVASCULAR PROCEDURE IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE GUIDEWIRE DURING DELIVERY OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DEVICE WAS WITHDRAWN AND UPON EXAMINATION IT WAS NOTED THAT THE TIP/OLIVE WAS BENT. THE DEVICE WAS DISCARDED AT THE SITE AND ANOTHER DEVICE WAS IMPLANTED WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782156 ↗
• InjuryMar 30, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER, TRUNK IPSILATERAL LEG C3, TWO CONTRALATERAL LEGS, TWO ILIAC EXTENDERS) AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (TWO ILIAC BRANCH COMPONENTS (IBE) AND TWO INTERNAL ILIAC COMPONENTS). ON (B)(6) 2026, PATIENT UNDERWENT A BILATERAL IBE REINTERVENTION PROCEDURE FOR THE TYPE 3 ENDOLEAK WITH AN ANEURYSM GROWTH (SIZE UNKNOWN) FROM THE LAST FOLLOW-UP PATIENT HAD (DATE UNKNOWN). FIELD SALES ASSOCIATE (FSA) NOTED THAT THE INFERIOR MESENTERIC ARTERY (IMA) WAS EMBOLIZED, AFTER WHICH, PHYSICIANS EXPLAINED TO FSA THAT THE PATIENT PREVIOUSLY UNDERWENT A REINTERVENTION FOR TYPE 2 ENDOLEAK AT APPROXIMATELY 1 TO 1.5-YEARS POST-OP EVAR INITIAL PROCEDURE. THE PHYSICIANS STATED THAT THE 1-YEAR POST EVAR REPAIR WAS DONE BY COIL EMBOLIZING A LARGE INFERIOR MESENTERIC ARTERY TO STOP ANEURYSM GROWTH FROM A TYPE 2 ENDOLEAK. THE PATIENT WAS THEN LOST IN FOLLOW-UPS UNTIL RECENTLY WHEN THE IMAGING SCANS REVEALED THAT THE PATIENT'S BRIDGE LIMBS INTO BOTH IBE DEVICES HAVE PULLED OUT CAUSING A TYPE 3 ENDOLEAK. THE BRIDGE LIMBS

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24719109 ↗
• InjuryMar 30, 2026Malposition of Device; Migration

  THE FOLLOWING WAS REPORTED TO GORE OVER THE IMEDIDATA DATABASE AND THE STUDY SITE: ON (B)(6) 2026, THE PATIENT UNDERWENT A PRE-OPERATIVE PROCEDURE TO TREAT HYDRONEPHROSIS, WHICH WAS SUCCESSFULLY RESOLVED BILATERALLY. PRIOR TO THE STUDY-SITE INTERVENTION, THE PATIENT WAS TREATED AT ANOTHER HOSPITAL FOR RENAL INSUFFICIENCY. DURING THAT HOSPITALIZATION, A URETERAL STENT WAS PLACED, AND THE PATIENT REMAINED ADMITTED FOR ONE WEEK. THE PATIENT PRESENTED LATER TO THE STUDY SITE AND WAS AN EMERGENCY CASE FOLLOWING AN INCIDENTAL FINDING OF A CLINICALLY RELEVANT ANEURYSM. THE STUDY SITE PERFORMED A BILATERAL ENDOVASCULAR PROCEDURE TO TREAT AN AORTOILIAC ANEURYSM AND RESOLVED THE FINDING ON (B)(6) 2026. DURING THE NIGHT OF (B)(6) 2026, A (B)(6) YEAR-OLD MALE PATIENT WAS OPERATED AND AN INTRA-PROCEDURAL RENAL ARTERY INTERVENTION TO PLACE TWO STENT GRAFTS (2X BXA062902E - GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) FOR LEFT AND RIGHT RENAL ARTERY WAS NECESSARY. IT WAS COMPLETED SUCCESSFULLY. FOLLOWING ALL PREVIOUSLY IMPLANTED GORE® DEVICES FOR THE ILIAC BRANCHES, IT WAS USED A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT, SN: (B)(6)) WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES - CONTRALATE

  Patient problems: Obstruction/Occlusion

  MAUDE report 24710522 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
• GORE TAG Conformable Thoracic Stent Graft25 models · 325 reports