GORE EXCLUDER AAA Endoprosthesis PLC271000Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00733132618538), received between Jan 2, 2019 and Jun 9, 2026 — classified as 1 death, 57 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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 63 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 8, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE VIA A TGR STUDY ALERT NOTIFICATION ON APRIL 27, 2026: ON (B)(6) 2025, THE PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ALL DEVICES WERE SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. FOLLOW-UP CTA IMAGING ON (B)(6) 2025 AND ON (B)(6) 2026 EACH REVEALED A TYPE II ENDOLEAK. BASED ON THESE FINDINGS, THE PHYSICIAN HAS ELECTED TO PLAN A REINTERVENTION ON (B)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 25124578 ↗
• InjuryMar 30, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE ON MARCH 4, 2026 FROM THE IMAGING DATABASE AND IMEDIDATA BASE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR A COMMON ILIAC ARTERY ANEURYSM. THE PATIENT WAS TREATED USING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN THE RIGHT COMMON ILIAC ARTERY AND RIGHT INTERNAL ILIAC ARTERY. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES. THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS IN THE INFRARENAL ABDOMINAL AORTA AND THE EXTENDER WAS IN LEFT RENAL ARTERY. ALL GORE® DEVICES WERE SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT A CTA, WHICH REVEALED A TYPE II ENDOLEAK. THE IMAGING SPECIALIST ALSO REPORTED A DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY, BEGINNING DISTAL TO THE STENT WITHIN THE LEFT COMMON ILIAC ARTERY. NO REINTERVENTION HAS OCCURRED.

  Patient problems: Clinical Endoleak

  MAUDE report 24729642 ↗
• InjuryJan 20, 2026Obstruction of Flow; Human-Device Interface Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE TRUNK IPSILATERAL LEG CONFORMABLE WAS DELIVERED UP THE PATIENT'S RIGHT SIDE THEN USED THE RE-CONSTRAINING AND ANGULATION WITH NO ISSUES AND DEPLOYED FINE. THE CONTRALATERAL LIMB WAS MEASURED AND DEPLOYED ON THE PATIENT'S LEFT SIDE WITH NO ISSUES THEN THE IPSILATERAL LIMB OF MAIN BODY DEPLOYED, AFTER WHICH, THE IPSILATERAL EXTENSION LIMB MEASURED AND DEPLOYED WITH NO ISSUES. THE FINAL BALLOONING WAS DONE WITH THE COOK CODA BALLOON BY THE VASCULAR ASSISTANT. THE BALLOON WAS POSITIONED AT THE PROXIMAL NECK, SLIGHTLY BELOW PROXIMAL GRAFT MARKERS JUST DISTAL TO THE RIGHT RENAL ARTERY, UPON INFLATION THIS SLIGHTLY PULLED THE MAIN BODY GRAFT DOWN FEW MILLIMETERS, HOWEVER, PHYSICIAN WAS OKAY WITH THE GRAFT POSITION & NO TYPE 1 ENDOLEAK WAS NOTED. THE RIGHT ILIAC OVERLAP AND DISTAL ILIAC WERE BALLOONED INSIDE THE GRAFT, UPON THE SECOND SQUEEZE OF THE BALLOON, THE RIGHT GRAFT LIMB 'POPPED' OUTWARD. THE GRAFT DID NOT DISCONNECT, ONLY THE BOTTOM OF

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 24122901 ↗
• InjuryDec 1, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, THE CUSTOMER REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT UNDERWENT ANOTHER ENDOVASCULAR PROCEDURE TO ADDRESS A LEAK UTILIZING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23682155 ↗
• InjuryNov 12, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2025, A REINTERVENTION OF 24-HOUR LYSIS WAS INITIATED, AND BLOOD FLOW WAS RESTORED TO TREAT GRAFT THROMBOSIS. ON (B)(6) 2025 AFTER LYSIS COMPLETED, A SUPRA RENAL FIXATION CUFF WAS IMPLANTED PROXIMAL TO THE IMPLANTED GRAFT. AN ADDITIONAL GRAFT WAS IMPLANTED DISTALLY TO EXTEND THE LIMB ON THE LEFT SIDE. THE PATIENT TOLERATED THE REINTERVENTION (CAPTURED UNDER (B)(4)). ON AN UNKNOWN DATE IN SEPTEMBER 2025, THE PATIENT UNDERWENT CTA IMAGING WHERE CONTRAST WAS SEEN OUTSIDE THE GRAFTS, INDICATING THE PATIENT HAD A TYPE 1B ENDOLEAK IN THE LEFT HYPOGASTRIC ARTERY AND IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE 1B ENDOLEAK IN THE LEFT HYPOGASTRIC ARTERY, DISTAL TO THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE (INTERNAL ILIAC COMPONENT). IN ADDITION, THE TYPE 1B ENDOLEAK WAS TREATED IN THE RIGHT COMMON ILIAC ARTERY, DISTAL TO A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE (27 MM CONTRALATERAL LEG ENDOPROSTHESIS). THE PATIENT HAD TWO PREVIOUSLY IMPLANTED 27 MM

  Patient problems: Clinical Endoleak

  MAUDE report 23535134 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT WAS IMPLANTED WITH GORE®EXCLUDER®AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM AND A GORE®EXCLUDER®ILIAC BRANCH ENDOPROSTHESIS (CEB) WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY (RCIA) AND EXTENDED INTO THE RIGHT INTERNAL ILIAC ARTERY (RIIA) USING GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. THE PHYSICIAN THEN EXTENDED COVERAGE OF THE CEB WITH A GORE®EXCLUDER®AAA CONTRALATERAL LEG DEVICE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS AND WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DETERMINED TO HAVE A THROMBOSED RCIA AND REIA (CEB231210A, PLC271000). ON (B)(6) 2025, THE PATIENT UNDERWENT THROMBECTOMY OF THE REIA AND RIGHT COMMON FEMORAL ARTERY (RCFA) BY OPEN FEMORAL ARTERY EXPOSURE. A GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED TO RELINE AND EXTEND COVERAGE DOWN TO THE EXTERNAL AND FEMORAL ARTERY. AN ANGIOGRAM SHOWED BOTH THE INTERNAL AND EXTERNAL ILIAC ARTERIES WERE OPEN AND PATENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22538307 ↗
• InjuryMay 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WITH A PREVIOUS GORE GRAFT HAS A TYPE 1B AND SUSPECTED POSSIBLE TYPE 1A ENDOLEAK PER CT SCANS. THE TYPE 1B ENDOLEAK IS ON THE LEFT LIMB AND PHYSICIAN PLANS TO DO A COIL EMBOLIZE OF THE LEFT HYPOGASTRIC ARTERY AND EXTEND INTO THE LEFT EXTERNAL ILIAC ARTERY UTILIZING A CONTRALATERAL LEG ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT THE REINTERVENTION PROCEDURE FOR THE TYPE 1B ENDOLEAK ON THE LEFT SIDE. DURING THE PROCEDURE, ANGIO WAS TAKEN WHICH SHOWED NO LEAKS FROM TOP PROXIMAL SIDE, THEREFORE, THE PHYSICIAN ELECTED NOT TO DO ANYTHING UP THERE BECAUSE HE DID NOT SEE A TYPE 1A LEAK. PHYSICIAN STATED THERE IS A 9CM AAA AND THE LEFT LIMB WAS COMPLETELY OFF THE WALL CAUSING THE LEAK. PROCEDURE WENT WELL AND PATIENT IS DOING FINE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22052016 ↗
• InjuryMar 15, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND UNILATERAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. AN RLT311413 TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S AORTA, A CEB231410A ILIAC BRANCH COMPONENT AND HGB161407A INTERNAL ILIAC COMPONENT WERE IMPLANTED IN THE PATIENT'S LEFT ILIAC ARTERY, AND A PLC271000 CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGING COMPONENT. A PLC231000 CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE IPSILATERAL LIMB. IMAGING EVALUATION SUGGESTS THAT THE PATIENT'S AORTIC NECK IS APPROXIMATELY 70 DEGREES. ON (B)(6) 2024, POST-IMPLANTATION NON-CONTRAST CT REVEALED THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT APPEARED TO BE COMPRESSED AT THE ANGULATED PORTION OF THE AORTA. ON (B)(6) 2025, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD PRESENTED WITH LEG PAIN. EVALUATION OF POST-IMPLANTATION CTA IMAGING, DATED (B)(6) 2025, REVEALED THAT THE AORTA HAD DISSECTED AND THAT THE ENTIRE DEVICE SYSTEM HAD THROMBOSED AND OCCLUDED. THE DISSECTION REPORTEDLY EXTENDED PROXIMAL TO THE PATIENT'S DESCENDI

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21613802 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH THE IMPLANTED GRAFT PARTIALLY THROMBOSED IN BOTH ILIAC ARTERY LIMBS AND THE MAIN BODY OF THE GRAFT HAD COLLAPSED DUE TO ANGULATION OF THE AORTA. ON (B)(6) 2025, A REINTERVENTION OF 24-HOUR LYSIS WAS INITIATED, RESULTING IN THE RESTORATION OF BLOOD FLOW TO THE PARTIALLY THROMBOSED AREA. ON (B)(6) 2025, AFTER LYSIS COMPLETED, A SUPRA RENAL FIXATION CUFF WAS IMPLANTED PROXIMAL TO THE IMPLANTED GRAFT. AN ADDITIONAL GRAFT WAS IMPLANTED DISTALLY TO EXTEND THE LIMB ON THE LEFT SIDE. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Thromboembolism

  MAUDE report 21351577 ↗
• InjuryOct 16, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENTS IN THE AAA1303 EXCC PIVOTAL STUDY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 61MM. ON (B)(6) 2022, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 66MM. A TYPE II ENDOLEAK WAS OBSERVED. NO TREATMENT WAS PERFORMED AND THE PATIENT WAS MONITORED. ON (B)(6) 2023, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 66MM. ON (B)(6) 2023, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 70MM. ON (B)(6) 2024, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 73MM. ON (B)(6) 2024, CT IMAGING REVEALED THAT THE MAXIMUM DIAMETER OF THE ANEURYSM/LESION WAS 84MM. ON (B)(6) 2024, THE SUBJECT PRESENTED TO THE FACILITY FOR FOLLOW-UP. IT WAS REPORTED THAT, DUE TO THE CONTINUED ANEURYSM ENLARGEMENT, A CONVERSION TO OPEN REPAIR WILL BE PERFORMED. THE PROCEDURE IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Clinical Endoleak

  MAUDE report 20466173 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE THROUGH THE PROCEDURE, SEVERAL UNITS OF BLOOD WERE GIVEN. ON (B)(6) 2024, APPROXIMATELY SEVEN HOURS POST ENDOVASCULAR PROCEDURE, THE PHYSICIAN REINTERVENED TO TREAT A DISTAL TYPE I ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED. REPORTEDLY ON (B)(6)2024, THE PATIENT EXPIRED. THE PHYSICIAN REPORTED THE PATIENT NEVER RECOVERED FROM BEING HEMODYNAMICALLY UNSTABLE DUE TO THE RUPTURED ABDOMINAL AORTIC ANEURYSM. THERE IS NO ALLEGATION THAT THE DEATH OR GORE DEVICE OR PROCEDURE CONTRIBUTED TO OR CAUSED THE PATIENT¿S DEATH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19726248 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS BRANCH COMPONENT (B)(6), GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL COMPONENT (B)(6), A GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(6), A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL COMPONENT HGB161407A, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS RLT281412. THE DEVICES WERE IMPLANTED IN THE RIGHT COMMON ILIAC. DURING THE PROCEDURE, THE SURGICAL TEAM MISSED AN ADDITIONAL (B)(6) THAT WAS USED AS A BRIDGE LIMB FROM THE CONTRALATERAL LIMB OF THE (B)(6) TO THE CEB (B)(6), AS WELL AS THE PREVIOUSLY NOTED PLC271000 THAT WAS USED TO EXTEND THE IPSILATERAL LIMB OF THE (B)(6) INTO THE LEFT COMMON ILIAC. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS TREATED FOR AN ANEURYSM IN THE LEFT COMMON ILIAC. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC121400. BECAUSE THE LEFT HYPOGASTRIC WAS TOO SMALL TO ALLOW IMPLANT OF AN IBE DEVICE, THE PHYSICIAN DECIDED TO INTENTIONALLY COVER THE VESSEL. THE PHYSICIAN STATED THAT THEY COULD NOT BE SURE IF THERE WAS A TYPE IB ENDOLEAK, AS THE PATIENT HAS POOR KIDNEY FUNC

  Patient problems: Clinical Endoleak

  MAUDE report 19639295 ↗
• InjuryJun 6, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A PLC271000 CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. THERE WERE NO REPORTED ISSUES WITH DEVICE PLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2024, A DISTAL TYPE I ENDOLEAK WAS OBSERVED FROM THE PLC271000 IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. THE PATIENT WAS TRANSFERRED TO (B)(6) FOR REINTERVENTION. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED BY (B)(6). A GORE® EXCLUDER® ILIAC BRANCH COMPONENT WAS IMPLANTED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE INTERNAL ILIAC ARTERY WAS PRESERVED AND THE ENDOLEAK WAS SUCCESSFULLY TREATED. THERE WERE NO PATIENT ADVERSE EVENTS DURING THE REINTERVENTION, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19480531 ↗
• InjuryMay 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THIS PATIENT PRESENTED WITH A POSSIBLE DISTAL TYPE 1B ENDOLEAK ASSOCIATED A WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) WITHIN THE LEFT COMMON ILIAC ARTERY (LCIA). THE PHYSICIAN NOTED DISEASE PROGRESSION IN THE PATIENT'S LCIA. THE PHYSICIAN DECIDED TO EXTEND COVERAGE OF THE CONTRALATERAL LEG DOWN TO THE EXTERNAL ILIAC ARTERY. ADDITIONALLY, COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC TO ARTERY WAS PERFORMED. THE CASE WAS COMPLETED WITHOUT INCIDENT AND PATIENT IS REPORTED TO BE DOING FINE WITH NO ENDOLEAK SEEN.

  Patient problems: Clinical Endoleak

  MAUDE report 19326016 ↗
• InjuryMar 29, 2024Partial Blockage; Malposition of Device; Partial Blockage; Malposition of Device

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES, (CEB231410A, CEB231010A, HGB161007A), AND TWO GORE® EXCLUDER® ENDOPROSTHESES, (PLC181000, PLC271000. THE PHYSICIAN INTENDED TO IMPLANT ONE OF THE EXCLUDERS HIGH IN THE FLOW DIVIDER OF THE MAIN BODY, BUT IT CAUSED MORE BLOCKAGE OF BLOOD FLOW THAN EXPECTED BECAUSE THE EXCLUDER COVERED THE OTHER SIDE OF THE GRAFT. THE PHYSICIAN COMPLETED THE PROCEDURE, BUT THEN BROUGHT THE PATIENT BACK INTO SURGERY AND IMPLANTED ANOTHER EXCLUDER, (PLC161000), ON THE OPPOSITE SIDE TO THE SAME LEVEL AS THE FIRST SIDE TO REMEDY THE ISSUE OF FLOW BLOCKAGE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 19004351 ↗
• InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2017, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND TWO LIMBS. THE PATIENT TOLERATED THE PROCEDURE. ON 3-MAR-2024, THE PATIENT PRESENTED WITH MID BACK PAIN. IMAGING SHOWED A DESCENDING AORTIC PAU. THE PHYSICIAN ALSO NOTED A POSSIBLE TYPE IA ENDOLEAK ON THE MAIN BODY, AND TYPE IB ENDOLEAKS ON EACH OF THE LIMBS. WHILE ATTEMPTING TO TREAT THE PAU, THE PHYSICIAN TORE THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN USED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM TO REPAIR THE PAU. THE PHYSICIAN THEN RELINED THE EXISTING GRAFTS, WHICH REPAIRED THE ENDOLEAKS AND THE TORN REIA. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN HAS NO OPINION ON THE CAUSE OF THE EVENT.

  Patient problems: Clinical Endoleak

  MAUDE report 18980078 ↗
• InjuryMar 21, 2024Migration; Migration

  ON (B)(6) 2022, PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION SURGERY DUE TO LEFT LIMB MIGRATING (DISTANCE UNKNOWN) PROXIMALLY FROM THE LEFT COMMON ILIAC ARTERY INTO THE AORTA. THERE ALSO WAS DILATION OF THE LEFT COMMON ILIAC ARTERY. PHYSICIAN EXTENDED THAT LIMB USING A PLC271400, SERIAL NUMBER (B)(6). PHYSICIAN ALSO FURTHER EXTENDED DISTALLY INTO THE REMAINING COMMON ILIAC ARTERY WITH A PLC231000. PHYSICIAN USED 5 ENDO ANCHORS IN THE DISTAL LIMB AT THE END AND THE FINAL RESULT SHOWED NO CURRENT ENDOLEAK. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE, AS PATIENT MISSED MANY FOLLOW-UP APPOINTMENTS. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18956549 ↗
• InjuryMar 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED AN ANEURYSMAL SEGMENT THAT HAD DEVELOPED DISTAL TO THE ORIGINAL IMPLANTED DEVICE. THERE WAS A REINTERVENTION ON (B)(6) 2024, THE PHYSICIAN IMPLANTED ADDITIONAL ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 18919222 ↗
• InjuryFeb 16, 2024Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. A CONFORMABLE TRUNK-IPSILATERAL LEG COMPONENT AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS WERE IMPLANTED. ON (B)(6) 2024, THE PHYSICIAN INFORMED THE GORE REPRESENTATIVE THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED DISTALLY APPROXIMATELY 3CM DOWN INTO THE ANEURYSM SAC. ADDITIONALLY, THROMBUS WAS OBSERVED IN THE DISTAL LIMBS AND IN THE PATIENT'S LEFT RENAL ARTERY. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT PRESENT. THERE WAS NO REPORTED PATIENT ANATOMY THAT WAS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ON THE SAME DAY, THE DEVICE SYSTEM WAS EXPLANTED. A LEFT RENAL ARTERY BYPASS WAS PERFORMED, A THROMBECTOMY WAS PERFORMED IN BOTH ILIAC ARTERIES, A DACRON GRAFT WAS SURGICALLY IMPLANTED, AND A CUT DOWN WAS PERFORMED AT THE PATIENT'S LEFT GROIN TO RESOLVE REMAINING THROMBUS. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18718561 ↗
• InjuryOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: I HAD A DR. DO A CASE ON AN OLD EXCLUDER PATIENT LOST TO FOLLOW UP. THE CASE AND DEVICES ARE IN THE IMAGES ATTACHED. THE FILMS ARE AVAILABLE ON THE CLOUD. MY UNDERSTANDING IS HE PRESENTED TO THE EMERGENCY ROOM WITH A RUPTURE FROM A TYPE 1B ENDO LEAK AROUND THE RIGHT LIMB. HIS WEIGHT WAS 121 KG. PAST MEDICAL HISTORY, SIGNIFICANT FOR PERIPHERAL ARTERY DISEASE, HYPERTENSION, HYPER CHOLESTEROLEMIA, AND CORONARY ARTERY DISEASE. MEDICATION¿S ARE LIPITOR, 50 MG, LIPITOR, 20 MG, ASPIRIN 325 MG. PROXIMAL CUFFS WERE PLACED TO THE LEVEL OF THE RIGHT RENAL DESPITE EVIDENCE OF LEAK. TO FIX THE RIGHT ILIAC LEAK, THE RIGHT INTERNAL ILIAC WAS COIL EMBOLIZED AND A 121000 PLACED PROXIMAL, THEN 121200 DISTAL IN THE RCIA. LASTLY, 161007 WAS PLACED ACROSS THE COILED VESSEL, AND EXTENDED INTO THE REIA. THERE WAS NO LEAK SEEN ON THE LEFT ILIAC SIDE. SHE WILL SEE THE PATIENT AND FOLLOW UP AND DISCUSS OPTIONS TO TREAT THE DILATING LEFT COMMON ILIAC ARTERY IN THE FUTURE. THE PHYSICIAN ATTRIBUTED THIS ISSUE TO OVERALL ARTERIAL DILATION FROM PROGRESSING DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922987 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6), 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM AND BILATERAL ILIAC AORTIC ANEURYSM TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT IMAGES DATED (B)(6), 2023, REVEALED A TYPE III ENDOLEAK (COMPONENT DISCONNECTION). THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAD SLIPPED OUT OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (LOT/SERIAL NUMBER IS UNKNOWN). REPORTEDLY THE PATIENT HAD TORTUOUS ANATOMY. ON (B)(6), 2023, THERE WAS A REINTERVENTION, THE AREA WAS BRIDGED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ((B)(6)). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17865784 ↗
• InjurySep 29, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (HGB161007A & CEB231010A), GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261218 & PLC271000). SOMETIME DURING A FOLLOW UP IN (B)(6) 2023 (DATE UNKNOWN), CTA SCANS SHOWED THE SEPARATION OF THE CONTRALATERAL LIMB AND THE IBE DEVICE AND THERE IS A LARGE COMMON ILIAC ANEURYSM (SIZE UNKNOWN). IT IS A TYPE 3 ENDOLEAK (COMPONENT DISCONNECTION). ON (B)(6) 2023, THE PATIENT WAS SCHEDULED TO UNDERGO A REINTERVENTION ON A SEPARATION BETWEEN THE IBE DEVICE AND THE 27MM BRIDGE PIECE (CONTRALATERAL) INTO THE COMMON ILIAC ANEURYSM FROM THE INITIAL IMPLANT. HOWEVER, ON THE DAY OF THE PROCEDURE, THE PATIENT HAD COVID DUE TO WHICH THE PHYSICIAN DELAYED THE REINTERVENTION BY 2-WEEKS AND IF PATIENT CONDITION WAS BETTER THEN THEY WILL INTERVENE. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT A ZONE 10- COMMON ILIAC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG) AND DOING A REVISION TO THE PRIOR EVAR. REPORTEDLY, THE CONTRALATERAL DEVICE (SN#(B)(6)) WAS TO

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17847232 ↗
• InjuryAug 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR (EVAR) PROCEDURE TO TREAT ABDOMINAL AORTA ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND TWO CONTRALATERAL LEGS). ONE OF THE CONTRALATERAL LEGS, A PLC271000 LIMB WAS USED TO SEAL THE RIGHT COMMON ILIAC ARTERY. THE INITIAL RESULT WAS SUCCESSFUL. DURING FOLLOW UPS, THE AAA SAC HAD GROWN. THE CT SCAN MEASUREMENTS WERE 63.7 MM X 54.5 MM ON (B)(6) 2021 AND 71.7 MM X 64.3 MM ON (B)(6) 2023. THE RIGHT COMMON ILIAC ARTERY APPEARED TO BE DEGENERATING AROUND THE PLC271000 CONTRALATERAL LIMB. REPORTEDLY, IT WAS FELT THERE WAS AN ENDOLEAK, BUT UNABLE TO TELL IF IT WAS A TYPE 1B OR TYPE 2. AN ANGIOGRAM WAS PERFORMED RECENTLY (DATE UNKNOWN) THAT DID NOT CLEARLY SHOW AN ENDOLEAK. DUE TO THE GROWTH AND SUSPICION OF A TYPE 1B ON THE RIGHT SIDE, THE PHYSICIAN DECIDED TO BRING THE PATIENT BACK FOR A REINTERVENTION PROCEDURE AND THAT IT WOULD TAKE CARE OF THE ENDOLEAK, IF IT WERE ACTUALLY PRESENT. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 10 COMMON ILIAC REVISION PROCEDURE WITH A RIGHT SIDED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PLACEMENT INT

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17595947 ↗
• InjuryJun 28, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 61.1MM. THE PATIENT TOLERATED THE PROCEDURE. FROM SEPTEMBER 6, 2018 TO DECEMBER 31, 2020 THE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCANS SHOWED THAT THE MAXIMUM ABDOMINAL AORTIC DIAMETER INCREASED FROM 61MM TO 67MM. REPORTEDLY, ON (B)(6) 2018, A BILATERAL ILIAC ARTERIES ANEURYSM ENLARGEMENT WAS NOTICED. ON (B)(6) 2020, THE PATIENT UNDERWENT A BILATERAL COMMON ILIAC ANEURYSM REPAIR WITH ILIAC BRANCH ENDOPROSTHESES ON BOTH SIDES. THE REINTERVENTION WAS DONE SUCCESSFULLY, HOWEVER, THE EVENT IS STILL ONGOING. ACCORDING TO THE PHYSICIAN, DISEASE PROGRESSION CAUSED THE ANEURYSM ENLARGEMENT. AT THE BEGINNING, BOTH RIGHT AND LEFT ARTERIES HAD THE HIGH AORTIC/VESSEL MEASUREMENTS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 17222153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)