GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231218Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132622351), received between Oct 4, 2018 and Mar 27, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Migration; Migration

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE LEFT IPSI LEG BARELY LANDED IN THE EXTERNAL ILIAC, AND THERE WAS CONCERN THAT THE GRAFT MIGHT PULL BACK INTO THE ANEURYSM. THE PHYSICIAN DECIDED AGAINST FURTHER ACTION AT THAT TIME, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A TYPE IB ENDOLEAK, AS THE IPSI LEG OF THE MAIN BODY HAD PULLED BACK INTO THE ANEURYSM. THE PHYSICIAN EXTENDED THE IPSI LIMB WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND REPAIRED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18987349 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2016. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 50.1MM. FROM (B)(6) 2018 TO (B)(6) 2020 THE FOLLOW UP SCANS SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 51MM TO 66MM. ON (B)(6) 2018, A TYPE IIB ENDOLEAK FROM 3 LUMBAR ARTERIES WAS FIRST NOTED. ACCORDING TO THE SITE, THE TYPE II ENDOLEAK WAS THE CAUSE OF THE ENLARGING SAC SIZE. ON (B)(6) 2020, THE PATIENT UNDERWENT A COILING EMBOLIZATION PROCEDURE. REPORTEDLY, COILING OF THE LUMBAR ARTERY WAS UNSUCCESSFUL, AND THE EXTENSION OF THE AORTIC STENT GRAFT WAS PERFORMED. THE PATIENT DISCHARGED HOME ON (B)(6) 2020. REPORTEDLY, THE ANEURYSM WAS MONITORED POST ENDOLEAK TREATMENT ON (B)(6) 2020. FURTHER TREATMENT WAS REQUIRED DUE TO THE INCREASING OF THE ANEURYSM SAC SIZE. ON (B)(6) 2021, THE AORTIC ANEURYSM/LESION WAS 60MM. ON (B)(6) 2021, A PERSISTENT TYPE IIB ENDOLEAK WAS DETERMINED, AND THE PATIENT UNDERWENT A PERCUTANEOUS CYANOACRYLATE GLUE AND LIPIODOL EMBOLIZATION PROCEDU

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18764163 ↗
• InjuryJan 27, 2022Structural Problem; Structural Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND A UNILATERAL RIGHT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE THE PATIENT THE PATIENT COMPLAINED OF LEFT SIDE CLAUDICATION. ON AN UNKNOWN DATE, FOLLOW COMPUTED TOMOGRAPHY (CT) DETERMINED COMPRESSION OF THE LEFT IPSILATERAL LIMB AT THE LEVEL OF THE FLOW DIVIDER. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION AND ANGIOJET THROMBECTOMY WAS PERFORMED FOLLOWED BY PLACEMENT OF A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE AREA OF COMPRESSION. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CONFIRM PATENCY OF THE GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13373907 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, A TYPE II ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, AN INTERVENTIONAL RADIOLOGIST PERFORMED A COIL EMBOLIZATION PROCEDURE WITH 2ML ONYX COILS AND THE PATIENT WAS DISCHARGED TO HOME ON THE SAME DAY.

  Patient problems: Aneurysm

  MAUDE report 11958130 ↗
• InjuryMar 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT WAS REPORTEDLY LOST TO FOLLOW-UP. ON (B)(6) 2020 THE PATIENT PRESENTED WITH ABDOMINAL PAIN. CT IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ANEURYSM ENLARGEMENT WAS REPORTED. AMOUNT OF ENLARGEMENT IS REPORTEDLY UNAVAILABLE. IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK WAS SHORT. NO FURTHER INFORMATION REGARDING THE PATIENT'S ANATOMY WAS AVAILABLE. THE ENDOLEAK WAS REPORTEDLY SUSPECTED TO BE CAUSED BY THE PATIENT'S SHORT ANGLE AORTIC NECK. REPORTEDLY THE PHYSICIAN OPTED TO EXPLANT ALL THREE IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESES, INCLUDING A TRUNK-IPSILATERAL LEG COMPONENT, AN AORTIC EXTENDER COMPONENT, AND A CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO THE ENDOLEAK AND THE AMOUNT OF ANEURYSM ENLARGEMENT, AS WELL AS THE SHORT ANGLE OF THE PATIENT'S AORTIC NECK NOT ALLOWING FOR ADDITIONAL TREATMENT OPTIONS. THE PATIENT TOLERATED THE EXPLANT PROCEDURE.

  Patient problems: Aneurysm; Pain

  MAUDE report 9901419 ↗
• InjuryNov 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS THROMBUS AND PLAQUE LOCATED IN THE PATIENT'S SUPERIOR AORTIC NECK THAT COULD HAVE CONTRIBUTED TO THE PROXIMAL TYPE I ENDOLEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373153 ↗
• InjuryMay 30, 2019Collapse; Collapse

  ON (B)(6) 2019, THIS PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, PRIOR TO THE (B)(6) 2019 PROCEDURE, THERE WAS A PREVIOUS STENTED DISSECTION THAT WAS PRESENT BEFORE THE ENDOGRAFT PLACEMENT IN THE DISTAL RIGHT COMMON ILIAC ARTERY WITH A 12MM X 30MM SELF-EXPANDING STENT. IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2019, WITH SYMPTOMS OF AN ISCHEMIC RIGHT LEG. COMPUTED TOMOGRAPHY REVEALED A COMPRESSION OF THE PROXIMAL GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS LIMB AT THE LEVEL OF THE BIFURCATION OF THE ENDOGRAFT. BOTH THE RLT231218 AND PLC121400 DEVICES WERE COMPRESSED AT THE PROXIMAL AREA OF OVERLAP, BOTH LIMBS WERE IN AN AREA WHERE THE AORTA MEASURES 16MM TOTAL. THERE IS A CT ON POST OP DAY ONE THAT SHOWS THIS, BUT THE IMAGES ARE NOT AVAILABLE TO GORE FOR EVALUATION. THE PHYSICIAN REINTERVENED AND DEPLOYED AN 8MM X 27MM BALLOON EXPANDABLE BARE METAL STENT AND POST DILATED TO 10MM. ANGIOGRAM REVEALED RESOLUTION OF COMPRESSION AND PALPABLE PULSE RETURNED TO THE RIGHT GROIN. THE FINAL ANGIOGRAM SHOWED NO SIGN OF EXTRAVASATION. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8656766 ↗
• InjuryFeb 18, 2019Adverse 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 85.7MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2017 THE ANEURYSM MEASURED 75MM. ON (B)(6) 2018 A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2018 THE ANEURYSM MEASURED 72MM. ON (B)(6) 2019 AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED.

  Patient problems: Aneurysm

  MAUDE report 8348572 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2018, REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE IS ANEURYSM SAC ENLARGEMENT, EXACT AMOUNT IS UNKNOWN. THE PHYSICIAN REINTERVENED ON (B)(6) 2018, AND IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS (B)(4), TO RELINE THE CURRENTLY IMPLANTED DEVICE. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8176711 ↗
• InjuryOct 20, 2018Adverse 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 49.7MM IN DIAMETER WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2015 THE ANEURYSM MEASURED 48.2MM. ON (B)(6) 2016 THE ANEURYSM MEASURED 45.7MM. ON (B)(6) 2017 THE ANEURYSM MEASURED 46.1MM. ON (B)(6) 2018 THE ANEURYSM MEASURED 52.1MM. ON (B)(6) 2018 THE ANEURYSM MEASURED 58.6MM. ON (B)(6) 2018 A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. A CT SCAN GUIDED EMBOLIZATION WAS PERFORMED WITH ONYX. ON (B)(6) 2018 THE ANEURYSM MEASURED 58.3MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988249 ↗
• InjuryOct 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, A POST-OPERATIVE COMPUTED TOMOGRAPHY SCAN REPORTEDLY REVEALED A COMPRESSED IPSILATERAL LIMB. ACCORDING TO THE REPORT, THE PATIENT¿S ABDOMINAL AORTA WAS NARROW (MEASURING APPROX. 18MM IN DIAMETER). IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC, BUT PHYSICIAN OPTED FOR RE-INTERVENTION AS A PRECAUTIONARY MEASURE. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY AN ADDITIONAL EXCLUDER® DEVICE WAS IMPLANTED TO PROVIDE ADDED RADIAL FORCE AND ENSURE DISTAL BLOOD FLOW. PATENCY OF THE IPSILATERAL LIMB WAS PRESERVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935093 ↗

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)