GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261216Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132622429), received between Aug 14, 2018 and Jun 30, 2023 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING ARTICLE WAS REVIEWED: ELIZABETH A. ANDRASKA, ET AL (2022) ¿LONGER FOLLOW-UP INTERVALS FOLLOWING ENDOVASCULAR AORTIC ANEURYSM REPAIR ARE SAFE AND APPROPRIATE AFTER MARKED ANEURYSM SAC REGRESSION, JOURNAL OF VASCULAR SURGERY, VOLUME 76, ISSUE 2, AUGUST 2022, PAGES 454-460. (HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S0741521422001926) HTTPS://DOI.ORG/10.1016/J.JVS.2022.01.079 THIS WAS A MULTIHOSPITAL SINGLE-INSTITUTION RETROSPECTIVE COHORT STUDY. ELECTIVE INFRARENAL EVARS PERFORMED BETWEEN 2008 AND 2011 WERE RETROSPECTIVELY REVIEWED. AAA SAC DIAMETERS USING THE MINOR AXIS MEASUREMENT FROM ULTRASOUND IMAGING OR COMPUTER TOMOGRAPHY ANGIOGRAM IMAGING WERE COMPARED WITH THE BASELINE DIAMETER FROM THE 1-MONTH POSTOPERATIVE COMPUTER TOMOGRAPHY ANGIOGRAM. THE PRIMARY OUTCOME WAS A COMPOSITE OF FREEDOM FROM POSTOPERATIVE REINTERVENTION OR RUPTURE. WE COMPARED THOSE WITH AAA SACS WHO REGRESSED TO PREDEFINED MINIMUM DIAMETER THRESHOLDS WITH THOSE WHO DID NOT. OUTCOMES WERE PLOTTED WITH KAPLAN-MEIER CURVES AND COMPARED USING LOG-RANK TESTING AND FINE-GRAY REGRESSION USING DEATH AS A COMPETING RISK, CLUSTERED ON GRAFT TYPE. FOR PATIENTS WHOSE AAA REACHED THE MINIMUM SAC DIAM

  Patient problems: Clinical Endoleak

  MAUDE report 17240723 ↗
• InjuryJun 29, 2023Migration; Migration

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT HAD AN ABDOMINAL ARTOGRAM. AFTER THE PROCEDURE, THE PATIENT LEFT THE OFFICE, BUT THEN REPORTED FEELING LIGHTHEADED, DIZZY AND NAUSEATED, AND THEY WENT TO AN ER. THE PATIENT ALSO REPORTED MILD LOWER BACK PAIN. THE ER DID A CT SCAN OF THE ABDOMEN/PELVIS, AND DISCOVERED A RETROPERITONEAL BLEED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND UNDERWENT A REINTERVENTION ON (B)(6) 2023. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM HAD MIGRATED DISTALLY APPROXIMATELY 2.5CM BELOW THE RENALS, AND THE NECK HAD DILATED UP TO 28-29MM. TWO CONFORMABLE EXCLUDER CUFFS WERE ADDED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Dizziness; Nausea; Pain

  MAUDE report 17225225 ↗
• InjuryMar 1, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED BY THE COMPLAINANT THAT, "AFTER EXPERIENCING PERSISTENT ABDOMINAL PAIN, [THE PATIENT] UNDERWENT COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) OF THE ABDOMEN AND PELVIS ON (B)(6) 2018." ON (B)(6) 2018, THE PHYSICIAN REVIEWED THE CTA WITH THE PATIENT. THE MEDICAL RECORDS REPORT THAT THE PATIENT WAS, "¿.REFERRED TO US BY DR. (B)(6) FOR ABDOMINAL AORTIC ANEURYSM." THE MEDICAL RECORDS REPORT, "...THE PATIENT WAS FOUND TO HAVE A 4.8CM AAA. HE COMPLAINS OF MIDLINE ABDOMINAL PAIN, BUT ALSO EPIGASTRIC PAIN THAT WORSENS AFTER HE EATS. CTA WAS REVIEWED AND SHOWS A 4.8CM AAA WITH PENETRATING ULCERS, AS WELL AS CELIAC STENOSIS. THE SMA IS WIDELY PATENT.¿ THE COMPLAINANT NOTES THAT, "THE CTA IMAGING OF [THE PATIENT'S] ANATOMY REVEALED THAT THERE WAS APPROXIMATELY 7 MILLIMETERS OF NORMAL AORTA BETWEEN THE RIGHT RENAL ARTERY AND THE SUPERIOR ASPECT OF THE ANEURYSM." THE COMPLAINANT FURTHER NOTES THAT, "...THE FDA-APPROVED LABELING FOR THE GORE C3 STENT GRAFT [GORE® EXCLUDER® AAA ENDOPROSTHESIS] REQUIRES AT LEAST 15 MILLIMETERS OF NORMAL AORTA BETWEEN THE LOWEST RENAL ARTERY AND THE SUPERIOR ASPECT OF THE ANEURYSM,". IT WAS NOTED BY THE COMPLAINANT THAT APPARENT, "ADVANCED TECHNIQUES, OUTS

  Patient problems: Obstruction/Occlusion

  MAUDE report 11393358 ↗
• InjuryJun 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 FOLLOW-UP CT IMAGING IDENTIFIED AN ENDOLEAK ORIGINATING AT THE BOTTOM OF THE CONTRALATERAL GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE ENDOLEAK WAS SUSPECTED TO BE EITHER A TYPE II OR TYPE III ENDOLEAK. NO ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2019 A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. REPORTEDLY ANGIOGRAPHY IDENTIFIED THAT THE ENDOLEAK WAS A TYPE II ENDOLEAK. THE PHYSICIAN PROPHYLACTICALLY IMPLANTED A GORE® EXCLUDER® PLL161407 ILIAC EXTENDER IN THE CONTRALATERAL GATE OF THE PREVIOUSLY IMPLANTED TRUNK-IPSILATERAL LEG COMPONENT. THE TYPE II ENDOLEAK WAS NOT EMBOLIZED. REPORTEDLY THE TYPE II ENDOLEAK PERSISTS. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8720250 ↗
• InjuryMay 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2019 THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO PLACE AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584482 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT REINTERVENTION FOR ANEURYSM ENLARGEMENT OF APPROXIMATELY 9MM WITHIN A THREE MONTH TIME PERIOD. THE PROXIMAL TRUNK WAS RELINED WITH TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS AND TWO GORE® CONTRALATERAL LEG COMPONENTS WERE USED TO RELINE THE LIMBS. AN ENDOLEAK WAS SUSPECTED HOWEVER INTRA-PROCEDURE IMAGING DID NOT IDENTIFY ANY ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8142951 ↗
• DeathAug 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ISOLATED ANEURYSM OF THE RIGHT COMMON ILIAC ARTERY IN THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AS WELL AS GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. ON (B)(6) 2018, COMPUTED TOMOGRAPHY IMAGING IDENTIFIED AN INFECTION AROUND THE ILIAC BRANCH ENDOPROSTHESES. AN ABSCESS IS HELD RESPONSIBLE FOR HAVING SPREAD THE BACTERIAL INFECTION TO THE PELVIC REGION. THERE WAS NO INFECTION KNOWN TO HAVE EXISTED IN THE AREA OF TREATMENT PRIOR TO DEVICE IMPLANT. ON (B)(6) 2018, ALL GORE® EXCLUDER ENDOPROSTHESES WERE REPORTED TO HAVE BEEN EXPLANTED DUE TO THE INFECTION. ON (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT HAS DIED. THE EXACT DATE AND CAUSE OF DEATH ARE CURRENTLY UNKNOWN.

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 7815797 ↗
• InjuryAug 14, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018 THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED AND IT WAS STATED THAT AFTER THE DEPLOYMENT WAS PERFORMED THE PROXIMAL END OF THE CONTRALATERAL GATE APPEARED CONSTRAINED AND WOULD NOT ALLOW PASSAGE OF A GUIDEWIRE. THE DISTAL END OF THE CONTRALATERAL GATE WAS REPORTED TO BE OPEN. ACCORDING TO THE PHYSICIAN, THE PROXIMAL END OF THE GATE APPEARED ¿TWISTED OR COLLAPSED¿. IT WAS REPORTED THERE WERE NO ANATOMICAL RESTRICTIONS THAT CAUSED OR CONTRIBUTED TO THE DEVICE REMAINING PARTIALLY CONSTRAINED AND THE EXACT CAUSE OF THE CONSTRAINED OR ¿TWISTED OR COLLAPSED¿ GATE IS REPORTEDLY UNKNOWN. SEVERAL ATTEMPTS TO ACCESS THE CONTRALATERAL GATE WERE REPORTEDLY UNSUCCESSFUL. IT WAS REPORTED THAT NO BLOOD FLOW WAS SEEN GOING THROUGH THE CONTRALATERAL GATE CREATING AN UNINTENTIONAL AORTO-UNI-ILIAC (AUI) DEVICE. IT WAS FURTHER REPORTED THAT A FEMORAL-FEMORAL BYPASS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7780026 ↗

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