GORE EXCLUDER AAA EndoprosthesisRecalls & reported problems across all models

We found 81 models of GORE EXCLUDER AAA Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 1,121 adverse event reports in the FDA's MAUDE database, received between May 5, 2016 and Sep 29, 2026 — classified as 45 deaths, 990 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (180 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 problems

GORE EXCLUDER AAA Endoprosthesis models

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

• GORE EXCLUDER AAA Endoprosthesis PLC271000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death63 reports
• GORE EXCLUDER AAA Endoprosthesis PLC271200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death56 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths40 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths34 reports
• GORE EXCLUDER AAA Endoprosthesis PLC271400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths33 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death33 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death29 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death29 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC141200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death28 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  27 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death26 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 deaths26 reports
• GORE EXCLUDER AAA Endoprosthesis PLC231000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  25 reports
• GORE EXCLUDER AAA Endoprosthesis PXC201000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• GORE EXCLUDER AAA Endoprosthesis PLC161200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death24 reports
• GORE EXCLUDER AAA Endoprosthesis PLC121200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  24 reports
• GORE EXCLUDER AAA Endoprosthesis PLA360400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 deaths22 reports
• GORE EXCLUDER AAA Endoprosthesis PLC161000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis PLC201200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death21 reports
• GORE EXCLUDER AAA Endoprosthesis PLC181000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis PLL161407

  System, Endovascular Graft, Aortic Aneurysm Treatment
  21 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death17 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  17 reports
• GORE EXCLUDER AAA Endoprosthesis PLA280300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 deaths17 reports
• GORE EXCLUDER AAA Endoprosthesis PXC201200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  16 reports
• GORE EXCLUDER AAA Endoprosthesis PXC181000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  15 reports
• GORE EXCLUDER AAA Endoprosthesis PLA260300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  14 reports
• GORE EXCLUDER AAA Endoprosthesis PLL161007

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths14 reports
• GORE EXCLUDER AAA Endoprosthesis PXC121200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXC141400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PLA320400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  13 reports
• GORE EXCLUDER AAA Endoprosthesis PXC141000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  12 reports
• GORE EXCLUDER AAA Endoprosthesis PXL161407

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death12 reports
• GORE EXCLUDER AAA Endoprosthesis PLA230300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths12 reports
• GORE EXCLUDER AAA Endoprosthesis PXC141200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  11 reports
• GORE EXCLUDER AAA Endoprosthesis PLC161400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  11 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death9 reports
• GORE EXCLUDER AAA Endoprosthesis PXC201400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death8 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281412

  System, Endovascular Graft, Aortic Aneurysm Treatment
  8 reports
• GORE EXCLUDER AAA Endoprosthesis PXC121000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PXC181400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281218

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281414

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281416

  System, Endovascular Graft, Aortic Aneurysm Treatment
  7 reports
• GORE EXCLUDER AAA Endoprosthesis PLL161207

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death7 reports
• GORE EXCLUDER AAA Endoprosthesis PXA230300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death6 reports
• GORE EXCLUDER AAA Endoprosthesis PXA280300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis PXC161200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231418

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis PXT311417

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• GORE EXCLUDER AAA Endoprosthesis PXA260300

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis PXC121400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis PXC161400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• GORE EXCLUDER AAA Endoprosthesis PXL161207

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis PXT311413

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis PXT311415

  System, Endovascular Graft, Aortic Aneurysm Treatment
  4 reports
• GORE EXCLUDER AAA Endoprosthesis PXC181200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis PXL161007

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261214

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis RLT281216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• GORE EXCLUDER AAA Endoprosthesis PXC161000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXT261216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXT281212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXC271200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXC271000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXC231000

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• GORE EXCLUDER AAA Endoprosthesis PXT231212

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE EXCLUDER AAA Endoprosthesis PXT281216

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE EXCLUDER AAA Endoprosthesis PXC231200

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• GORE EXCLUDER AAA Endoprosthesis PXC231400

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent GORE EXCLUDER AAA Endoprosthesis adverse event reports

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

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore on September 17, 2026 from the iMedidata database: On (b)(6) 2026, a patient with abdominal aortic aneurysm (no iliac involvement) underwent primary procedure for endovascular treatment. One GORE® EXCLUDER® Conformable AAA Endoprosthesis was implanted in infrarenal abdominal aorta, two GORE® EXCLUDER® AAA Endoprosthesis were implanted in the left and right common iliac artery respectively.On (b)(6) 2026, a subtle and non-flow limiting small dissection membrane in the right and left external iliac artery was reported. The dissection is uncomplicated and not adjacent to the stent grafts. This event is listed as related to treatment/procedure, ongoing, and not caused by a Gore accessory, No treatment is required. On (b)(6) 2026, the patient was discharged from the hospital.

  Patient problems: Aortic dissection

  MAUDE report 50929833 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Aortic dissection

  MAUDE report 50929830 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, this patient underwent endovascular treatment for an Aortoiliac aneurysm (AAA) and was implanted with GORE® EXCLUDER® Conformable AAA ENDOPROSTHESIS devices. Additionally, during the index procedure the patient¿s right common iliac artery was coil embolized. Pre-procedure computed tomography angiography (CTA) performed on (b)(6) 2026, determined the maximum diameter of the abdominal aorta measured 59mm, with a maximum diameter proximal landing zone of 24mm. The maximum diameter of the right common iliac artery (RCIA) measured 37.7mm and the maximum diameter of the left common iliac artery (LCIA) measured 32mm. Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system was reported. There were no corrective procedure(s) or complications related to the device, procedure, or withdrawal of the delivery system. The patient tolerated the procedure and was discharged to home (self-care) on (b)(6) 2026. On (b)(4), 2026, the patient experienced ongoing buttock claudication related to the treatment/procedure.On an unknown date in (b)(6) 2026, a type II Endo leak was determined and reported to be due to

  Patient problems: Reduced Blood Flow

  MAUDE report 50168745 ↗
• InjuryJul 27, 2026Device Endoleak

  The following was reported: On (b)(6) 2026, the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm. The patient was treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprostheses. The GORE® devices were successfully implanted. The patient was discharged on (b)(6) 2026. On (b)(6) 2026, the patient underwent a CTA. GIS noted that the patient had a Type II Endoleak. The clinical site reported that the patient had a Type IA Endoleak. The physician stated that a reintervention procedure is scheduled for (b)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 50046107 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. DURING THE PROCEDURE, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICE, A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE USED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FLOW LIMITING EXTERNAL ILIAC DISSECTION WAS CONDUCTED BY A CTA. IT WAS NOTED THAT THE LIKELY CAUSE OF RIGHT EXTERNAL ILIAC DISSECTION WAS DUE TO CLAMP INJURY FROM THE ILIAC CONDUIT. NO IMPLANTED DEVICES WERE ATTRIBUTED TO THE DISSECTION. ACCORDING TO THE PHYSICIAN, NO OCCLUSION OF THE DEVICE OR VESSEL WAS NOTICED. IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT UNDERWENT THE RIGHT ILIAC ARTERY STENTING (TWO GRAFTS WERE IMPLANTED). THE EVENT WAS RESOLVED. THE PATIENT IS DOING WELL. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Vascular Dissection

  MAUDE report 25616336 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTOILIAC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIA)WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 56MM WITH A MAXIMUM DIAMETER PROXIMAL LANDING ZONE OF 25.4MM. THE MAXIMUM DIAMETER OF THE RICA AND LCIA WERE NOT PROVIDED. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP CTA AND WAS REPORTED TO HAVE A TYPE II ENDOLEAK INVOLVING THE INFERIOR MESENTERIC ARTERY (IMA) AND LUMBAR ARTERIES. THERE IS NO LOSS OF PATENCY TO A GORE® DEVICE AND NO DEVICE INTEGRITY EVENTS REPORTED. THIS EVENT IS NOTED TO BE ON GOING AND NO TREATMENT WAS PROVIDED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25450226 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449443 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED SLIGHT ANEURYSM SAC ENLARGEMENT WITH A PERSISTENT TYPE II ENDOLEAK RELATED TO THE L3/L4 LUMBAR ARTERIES. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION FOR THE TYPE II ENDOLEAK AND ENDOANCHORS WERE PLACED. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 25447367 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. ADDITIONALLY, ENDOSTAPLES /ENDOANCHORS WERE PLACED DURING THE INDEX PROCEDURE. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58 MM. THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 15.4 MM AND LEFT COMMON ILIAC ARTERY (LCIA) MEASURED 12.5MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58MM. NO ENDOLEAKS OR OTHER DEVICE INTEGRITY EVENTS WERE REPORTED. ON (B)(6) 2026, THE PATIENT UNDERWENT FOLLOW-UP CTA WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 58MM. NO ENDOLEAKS OR

  Patient problems: Vascular Dissection

  MAUDE report 25446734 ↗
• InjuryJun 5, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS IN CONJUNCTION WITH GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE PROCEDURE WAS INITIALLY PLANNED AS A UNILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE) APPROACH; HOWEVER, DUE TO TORTUOUS ILIAC ANATOMY, THIS APPROACH WAS DETERMINED TO BE NOT FEASIBLE. DURING VASCULAR ACCESS PREPARATION USING PROGLIDE, AND PRIOR TO INITIATION OF THE INTENDED ENDOVASCULAR REPAIR, A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED. AS THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECREASE, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS DEPLOYED ACROSS THE RIGHT EXTERNAL ILIAC ARTERY TO CONTROL BLEEDING. FOLLOWING HEMODYNAMIC STABILIZATION, THE TREATING TEAM ELECTED TO ABANDON THE IBE APPROACH DUE TO INCREASING PROCEDURAL COMPLEXITY AND DURATION AND PROCEEDED WITH A STANDARD AAA EVAR, WHICH INCLUDED COIL EMBOLIZATION AND COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY. FINAL INTRAOPERATIVE IMAGING DEMONSTRATED SATISFACTORY RESULTS, AND THE PATIENT WAS TRANSFERRED TO RECO

  Patient problems: Clinical Endoleak

  MAUDE report 25414745 ↗
• DeathMay 28, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. REPORTEDLY, THE DEVICES WERE USED ACCORDING TO THE GORE INSTRUCTIONS FOR USE (IFU). ON (B)(6) 2026 A PROXIMAL TYPE I ENDOLEAK WAS NOTICED. ACCORDING TO THE PHYSICIAN, CALCIUM IN THE NECK AND IN THE INFERIOR ASPECT OF THE RENAL ARTERY CAUSED A PROXIMAL TYPE I ENDOLEAK. REPORTEDLY, ON (B)(6) 2026, THE TYPE I ENDOLEAK WAS BALLOONED USING A COOK CODA BALLOON. ACCORDING TO THE PHYSICIAN, BALLOONING IN ANATOMY WAS THE CAUSE OF THE AORTIC RUPTURE, HOWEVER, THE PHYSICIAN INFLATED THE BALLOON IN STANDARD PRACTICE. REPORTEDLY, AT THE PROCEDURE, THE PATIENT WAS CONVERTED TO AN OPEN REPAIR AND A BIFURCATED SURGICAL GRAFT WAS INSERTED. IT WAS REPORTED THAT BOTH AORTIC EXTENDERS AND THE PROXIMAL PART OF THE MAIN BODY WERE EXPLANTED. THE PHYSICIAN CUT THE BIFURCATED BODY AND LEFT THE LIMBS IN. THEN A GRAFT TO THE LIMBS WAS SUTURED. THE RUPTURE WAS SOLVED. THE PATIENT WAS RECOVERING IN THE HOSPITAL. (THIS INFORMATION WAS COVERED AND REPORTED UNDER THE REPORT# 3007284313-2026-04758). ALSO, THE

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

  MAUDE report 25322733 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ALLEGEDLY, ON (B)(6) 2026, DURING A CT SCAN, AN ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN) WAS OBSERVED DISTALLY. NO ENDOLEAK OR OTHER ISSUES WERE NOTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH A PLC231000 DEVICE WAS IMPLANTED DISTAL TO AN EXISTING CONTRALATERAL LIMB ON THE RIGHT SIDE, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 25273234 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ALLEGEDLY, ON (B)(6) 2026, DURING A CT SCAN, AN ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN) WAS OBSERVED DISTALLY. NO ENDOLEAK OR OTHER ISSUES WERE NOTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH A PLC231000 DEVICE WAS IMPLANTED DISTAL TO AN EXISTING CONTRALATERAL LIMB ON THE RIGHT SIDE, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 25271572 ↗
• 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 25236952 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT INTERNAL ILIAC ARTERY WAS PARTIALLY COVERED. THIS WAS UNPLANNED, THE PATIENT HAD ¿SHORT¿ ANATOMY. THERE WAS PARTIAL FLOW AT THE END OF THE PROCEDURE. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25185013 ↗

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

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