GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261416Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00733132622467), received between Oct 11, 2018 and Sep 10, 2025 — classified as 2 deaths, 37 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN APPLICATION UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). ON (B)(6) 2025, FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THERE IS A TYPE 1A AND 1B ENDOLEAK ON THE PATIENT'S RIGHT SIDE WITH AN EXCLUDER GRAFT. ON (B)(6) 2025, ADDITIONAL INFORMATION RECEIVED THAT THERE IS A CONFIRMED TYPE 1A ENDOLEAK BASED ON CT SCANS AS ANEURYSM HAS GROWN TO 7CM. PHYSICIAN IS PLANNING A REINTERVENTION BUT PROCEDURAL DETAILS AND DATE HAS NOT BEEN DECIDED YET.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23015549 ↗
• InjuryJul 17, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 55 MM IN DIAMETER. REPORTEDLY, THE INFERIOR MESENTERIC ARTERY WAS COIL EMBOLIZED. ON (B)(6) 2021, A TYPE II ENDOLEAK WITH SAC ENLARGEMENT WAS DIAGNOSED MEASURING 60 MM COMPARED TO 48 MM ON (B)(6) 2020. ON (B)(6) 2022 COIL EMBOLIZATION WAS PERFORMED. IT ALSO WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT EXPIRED DUE TO A REASON UNKNOWN AND UNRELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22528919 ↗
• InjuryJul 3, 2025Material Deformation; Device Endoleak; Material Deformation; Device Endoleak

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2025 A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED IN A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM. FOR 30 DAY FOLLOW-UP EXAM, ON (B)(6) 2025, THE PHYSICIAN DISCOVERED A TYPE 1A ENDOLEAK DUE TO THE PROXIMAL PART OF THE DEVICE NOT BEING FULLY EXPANDED. THERE IS NO PROBLEM FOR THE PATIENT, AND THE PHYSICIAN PLAN TO BALLOON THE DEVICE IN THE NEXT DAYS. IT WAS ADDITIONALLY REPORTED THAT THE STATE OF THE DEVICE EXPANSION DURING THE INITIAL IMPLANT PROCEDURE WAS NOT DISCLOSED.

  Patient problems: Clinical Endoleak

  MAUDE report 22393358 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2016, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 45MM. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP IMAGING FROM (B)(6) 2016 TO (B)(6) 2021 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS STABLE IN SIZE 42MM. THE FOLLOW UP IMAGING FROM (B)(6) 2023 TO (B)(6) 2024 SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 53MM TO 67MM. ON (B)(6) 2024, A TYPE II ENDOLEAK WAS NOTICED. ON (B)(6) 2024, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE. REPORTEDLY, THIS PROCEDURE WAS UNSUCCESSFUL AS THE SURGEON WAS UNABLE TO GET A PROPER ACCESS TO THE ANEURYSM FOR EMBOLIZATION. ON (B)(6) 2024, A REINTERVENTION PROCEDURE OCCURRED, AND ALL DEVICES WERE EXPLANTED. THE PROCEDURE WAS COMPLETED VIA OPEN REPAIR. THE PATIENT TOLERATED PROCEDURE WELL. ON (B)(6) 2024, THE PATIENT HAD A BACTEREMIA AND WAS TREATED BY IV ANTIBIOTICS. ACCORDING TO THE SURGEON WHO PERFORMED THE EXPLANT, AFTER REVIEWING THE CASE AVAILABLE NOTES IN THE PATIENT'S C

  Patient problems: Aneurysm expansion; Bacteremia; Clinical Endoleak

  MAUDE report 21509507 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  IT WAS REPORTED TO GORE (THOUGHT A GEPROMED LEVEL 1 MACROSCOPIC ANALYSIS FOR EXPLANTED GRAFTS 24-022) THAT A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS IMPLANTED ON (B)(6) 2021, IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (MEASURED 75 MM). ON (B)(6) 2021, A TYPE II ENDOLEAKS FROM THE LUMBAR ARTERIES WERE VISUALIZED ON THE ANGIOSCAN. ON (B)(6) 2024, AFTER ABOUT 2 YEARS AND 7 MONTHS, THE ENDOPROSTHESIS WAS EXPLANTED DUE TO THE TYPE II ENDOLEAK FROM THE LUMBAR ARTERIES WITH ENLARGEMENT OF THE ANEURYSM SAC (88 MM).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19379594 ↗
• DeathFeb 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 64.4MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE FOLLOW UP ULTRASOUND DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 62MM. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPIRED DUE TO THE ANEURYSM RUPTURE. NO TREATMENT WAS DONE. ACCORDING TO THE SITE THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE INFORMATION WAS PROVIDED BY RELATIVES. NO MORE INFORMATION IS AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE SITE: WE DON'T HAVE THE FURTHER RECORDS AS OF NOW. WE HAVE SENT THE REQUEST FOR FURTHER INFORMATION FROM OHIO DEPARTMENT OF HEALTH AND ALSO GRANT MEDICAL CENTER WHERE HE WAS HOSPITALIZED BACK IN (B)(6) 2023. WE WILL UPDATE YOU AS SOON AS WE GET THE FORMAL DOCUMENTS. BEFORE WE GET THE FORMAL DOCUMENTS, WE CANNOT STATE IF THE EVENT WAS RELATED OR UNRELATED TO THE DEVICE. IT WILL BE UPDATED AS SOON AS WE GET THE RECORDS.

  Patient problems: Insufficient Information; Ruptured Aneurysm

  MAUDE report 18717148 ↗
• MalfunctionDec 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE TRUNK IPSILATERAL LEG WAS IMPLANTED USING A BALLERINA TECHNIQUE. POST OPERATIVE IMAGING SHOWED COMPRESSION OF THE TRUNK IPSILATERAL LEG WHERE IT PASSES UNDER THE CONTRALATERAL LEG IN A BALLERINA TECHNIQUE. A POSSIBLE WIRE FRACTURE IN THE TRUNK IPSILATERAL LEG WAS ALSO REPORTED. NO ENDOLEAKS WERE OBSERVED AND THE DEVICES WERE PATENT. THE DEVICE APPEARS TO BE COMPRESSED BUT HEMODYNAMICS APPEAR TO BE NORMAL AND THE PATIENT IS NOT PRESENTING WITH ANY SYMPTOMS. NO REINTERVENTION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272785 ↗
• MalfunctionSep 8, 2023Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE CONTRALATERAL GATE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM WAS COLLAPSED AFTER DEPLOYMENT. REPORTEDLY, THE DEVICE DID NOT OPEN FULLY IN THE GOLDEN RING OF THE CONTRALATERAL GATE OF THE MAIN BODY. ALL OTHER PARTS IN THE TRUNK AND GATE DID OPEN. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE PROBLEM. THE PHYSICIAN CONFIRMED THAT THE ANATOMY WAS NOT AN ISSUE FOR THIS PROBLEM. IT WAS ABLE TO SOLVE THE PROBLEM BY COMING FROM ABOVE AND SNARED IN THE AAA SACK. REPORTEDLY, A GORE® MOLDING & OCCLUSION BALLOON WAS USED AT THE CONTRALATERAL GATE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING FINE.

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

  MAUDE report 17716479 ↗
• InjuryJul 7, 2022Microbial Contamination of Device; Microbial Contamination of Device

  ON (B)(6) 2015, A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (MEASURED 50.6 MM) WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(4). ON (B)(6) 2021, THE PATIENTS WAS ADMITTED WITH TYPE II ENDOLEAK AND A SUDDEN GROWTH OF THE ANEURYSMAL SAC (80 MM). THE ENDOLEAK WAS EMBOLIZED WITH SOME METALLIC SPIRAL AND GLUE. THIS EVENT WAS REPORTED SEPARATELY WITH MANUFACTURER REPORT NUMBER 3007284313-2022-02017. AFTER THE PROCEDURE THE PATIENT STARTED WITH A FEVER AND COVID POSITIVE RESULTS AND WAS MOVED TO COVID WARD. AFTER THE FLOGISTIC INDEX CONTINUES TO BE HIGH A MONTH LATER, AN ANTIBIOTIC THERAPY AND INFECTIVE CONSULTATION WAS INITIATED. ON (B)(6) 2022, AFTER A MISSED CLINICAL IMPROVEMENT A PET SCAN WAS PERFORMED THAT CONFIRMED INFECTION OF STENT GRAFT. IT WAS REPORTED THAT IT IS NOT POSSIBLE TO CONFIRM IF THE INFECTION IS RELATED TO THE EMBOLIZATION OR DUE TO PRIOR ILLNESSES. ON (B)(6) 2022, THE PATIENT UNDERWENT CONVERSION AND RECEIVED A BIOLOGICAL GRAFT REPLACEMENT. THE EXPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS TESTED POSITIVE FOR STAPHYLOCOCCUS CAPITIS AND STAPHYLOCOCCUS LUGDUNENSIS, POSTOPERATIVE HEMOCULTURE TESTED POSITIVE FOR CANDIDA ALBICANS. ON (B)(6) 2022, IT WAS

  Patient problems: Bacterial Infection; Fungal Infection

  MAUDE report 14943462 ↗
• InjuryJul 7, 2022Microbial Contamination of Device; Patient-Device Incompatibility; Microbial Contamination of Device; Patient-Device Incompatibility

  ON (B)(6) 2015, A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (MEASURED 50.6 MM) WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(4). ON (B)(6) 2021, THE PATIENTS WAS ADMITTED WITH TYPE II ENDOLEAK AND A SUDDEN GROWTH OF THE ANEURYSMAL SAC (80 MM). THE ENDOLEAK WAS EMBOLIZED WITH SOME METALLIC SPIRAL AND GLUE. IN WAS ADDITIONALLY REPORTED THAT AFTER THE PROCEDURE THE PATIENT STARTED WITH A FEVER AND COVID POSITIVE RESULTS AND WAS MOVED TO COVID WARD.

  Patient problems: Aneurysm; Aneurysm expansion; Clinical Endoleak

  MAUDE report 14943422 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2022, FOLLOW UP EXAMINATION REVEALED A TYPE II ENDOLEAK. THE REINTERVENTION FOR THE TYPE II ENDOLEAK WAS PERFORMED ON (B)(6) 2022, HOWEVER, THE PHYSICIAN COULD NOT ACCESS THE LUMBAR ARTERIES THAT WERE CAUSING THE TYPE II DUE TO ANATOMICAL RESTRICTIONS. THE PHYSICIAN IS GOING TO PERFORM A CT IN THE NEXT FEW MONTHS TO ASSESS PATIENT CONDITION. THE ANEURYSM SAC HAS GROWN OVER 5MM IN THE PAST YEAR.

  Patient problems: Aneurysm

  MAUDE report 14289276 ↗
• InjuryFeb 8, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ILIAC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM, A GORE® EXCLUDER® AAA ENDOPROSTHESIS, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT TOLERATED THE PROCEDURE. ON THE ONE MONTH FOLLOW UP VISIT, IT WAS REPORTED LIMB COMPRESSION OCCURRED IN THE GATE AREA OF THE MAIN BODY, CAUSING LEFT LEG CLAUDICATION. THE PHYSICIAN PLANS TO REINTERVENE ON (B)(6) WITH KISSING VBX STENTS AT THE LEVEL OF THE MAIN BODY FLOW DIVIDER. RECEIVED INFORMATION FROM FSA. REINTERVENTION WAS PERFORMED ON (B)(6) 2022. PHYSICIAN GAINED BILATERAL ACCESS AND PLACED BILATERAL KISSING 11 MM VBX STENTS IN THE COMPRESSED AREA OF THE LIMB. IVUS CONFIRMED PATENCY. PHYSICIAN REPORTS PALPABLE PULSES ON THE LEFT FOOT WHICH WERE PREVIOUSLY ABSENT.

  Patient problems: Numbness

  MAUDE report 13484689 ↗
• InjuryJan 31, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION TO TREAT A POSSIBLE TYPE IB ENDOLEAK. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392875 ↗
• InjurySep 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2019 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED DISTAL TYPE I ENDOLEAK AND ENLARGEMENT OF THE ANEURYSM. THE IPSILATERAL LEG WAS RELINED WITH TWO ADDITIONAL GORE® EXCLUDER® ENDOPROSTHESES AND EXTENDED COVERAGE TO THE LEFT HYPOGASTRIC ARTERY. ANGIOGRAPHY PERFORMED INTRAPROCEDURE WAS UNABLE TO VISUALIZE AN ENDOLEAK. THE AMOUNT OF ANEURYSM ENLARGEMENT WAS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT ANGIOGRAPHY AND A PROXIMAL TYPE I ENDOLEAK WAS DETERMINED AND SHOWED THE ANEURYSM HAD ENLARGED TO 8CM. THE PHYSICIAN IS DISCUSSING A COURSE OF TREATMENT WITH THE PATIENT WHICH MAY INCLUDE EXPLANT OF THE DEVICES. IT WAS REPORTED THAT DEVICE APPOSITION IS POOR AT THE AREA OF THE RENAL ARTERIES DUE TO CALCIFICATION OF THE AORTIC NECK IN THIS AREA, NO DEVICE MIGRATION REPORTED.

  Patient problems: Aneurysm

  MAUDE report 12555573 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT IMPLANT OF A PACEMAKER. A GROIN INFECTION WAS IDENTIFIED POST PROCEDURE, WHICH WAS SUSPECTED TO HAVE SPREAD TO THE GORE® DEVICES, DEMONSTRATED BY A WHITE BLOOD CELL SCAN. THEREFORE, ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN SURGICAL CONVERSION WHEREBY THE GORE® DEVICES WERE EXPLANTED AND REPLACED WITH AN AORTO-BIFEMORAL DACRON GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 12513225 ↗
• InjuryAug 17, 2021Adverse 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) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE ANEURYSM MEASURED 61 MM. ON (B)(6) 2021, A TYPE II ENDOLEAK WAS DISCOVERED AND TREATED BY MEANS OF EXPLANTATION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH AORTO-BI-ILIAC BYPASS.

  Patient problems: Aneurysm

  MAUDE report 12331952 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. BETWEEN FOLLOW UP DATES ON (B)(6) 2021 AND (B)(6) 2021, THE ANEURYSM HAS EXPANDED FROM 5.5 CM TO 7.1 CM WITH AN UNDETERMINED SOURCE OF ENDOLEAK. ON (B)(6) 2021, A REINTERVENTION OCCURRED TO TREAT THE UNIDENTIFIED ENDOLEAK. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS EXTENDED PROXIMALLY WITH AN AORTIC EXTENDER ENDOPROSTHESIS TO THE LEFT RENAL ARTERY, AND DISTAL EXTENSION WAS ACHIEVED INTO THE RIGHT COMMON ILIAC WITH A CONTRALATERAL LEG ENDOPROSTHESIS TO RULE OUT WHAT WAS PERCEIVED AS POSSIBLE TYPE I PROXIMAL AND TYPE I DISTAL ENDOLEAKS. THE PROCEDURE CONCLUDED SUCCESSFULLY, AND THE PATIENT WILL BE FOLLOWED UP LATER TO SEE IF THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 11855901 ↗
• InjuryApr 14, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  I AM FORWARDING INFORMATION I RECEIVED TODAY FOR A CASE FROM (B)(6). PATIENT NAME: (B)(6). DOB: (B)(6). ENDOLEAK: TYPE 1A. DEVICE: EXCLUDER. 2 CTA IMAGE SETS (GORE CLOUD): (B)(6) 2016 AND (B)(6) 2021.

  Patient problems: Aneurysm

  MAUDE report 11666062 ↗
• InjuryApr 5, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A MAXIMUM DIAMETER MEASURING 50.3MM. FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2017, AN ENDOLEAK OF INDETERMINATE ORIGIN WAS OBSERVED. ON THE SAME DAY AN INTERVENTION WAS PERFORMED WHEREBY THE ENDOLEAK WAS EMBOLIZED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 11616524 ↗
• InjuryMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2017, THIS PATIENT UNDERWENT TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO A PROXIMAL TYPE I ENDOLEAK. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 11478107 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 50MM IN DIAMETER AND WAS IMPLANTED WITH GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. THE PATIENT IS ENROLLED IN THE GRT 10-11 STUDY. THE PATIENT TOLERATED THE INITIAL PROCEDURE. THE FOLLOW-UP ON (B)(6) 2016, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 48MM. REPORTEDLY, FROM (B)(6) 2017 TO (B)(6) 2020, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 49MM TO 58MM. IT WAS REPORTED THAT ON (B)(6) 2020, A TYPE II ENDOLEAK WAS DETERMINED AND THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11346492 ↗
• InjuryOct 23, 2020Adverse 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) 2015 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 65.2MM IN DIAMETER WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018 A PROXIMAL TYPE I AND A TYPE II ENDOLEAK WAS DISCOVERED. THE MAXIMUM AORTIC DIAMETER WAS 72MM BY ULTRASOUND. THE TYPE II WAS FROM THE SMA TO IMA. ON (B)(6) 2018 THE TYPE II ENDOLEAK WAS TREATED BY MEANS OF COIL EMBOLIZATION. ON (B)(6) 2019 AN ADDITIONAL AORTIC ENDOGRAFT OF UNKNOWN TYPE WAS IMPLANTED TO TREAT THE TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10731067 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE ANEURYSM MEASURED 61 MM. FOLLOW UP EXAMINATION ON (B)(6) 2020 REVEALED THE ANEURYSM MEASURED 80 MM ALONG WITH A TYPE II ENDOLEAK. ON (B)(6) 2020 A REINTERVENTION TOOK PLACE WHEREBY CT GUIDED EMBOLIZATION OF THE TYPE II ENDOLEAK WAS PERFORMED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME SELF-CARE ON THE SAME DAY.

  Patient problems: Aneurysm

  MAUDE report 10541612 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2020, A TYPE II ENDOLEAK WAS DISCOVERED ON FOLLOW UP EXAMINATION. ANEURYSM ENLARGEMENT OF GREATER THAN 5MM WAS ALSO NOTED. ON (B)(6) 2020, COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY AND LT ILIOLUMBAR ARTERY WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 10138861 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN INFLAMMATORY AORTA COMPLICATED BY CANCER TREATMENT WITH CHEMOTHERAPY. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH CONTINUED ANEURYSMAL DEGRADATION AT THE PROXIMAL END OF THE GRAFT AND IN THE LEFT COMMON ILIAC ARTERY. THAT DAY THE PHYSICIAN PLACED THREE COOK ENDOVASCULAR CUFFS PROXIMALLY UP TO THE NEXT RENAL ARTERY ALONG WITH A GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS (PLL161007 LOT #20056981) IN THE LEFT COMMON ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10094560 ↗

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