GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281414Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132610716), received between Jun 29, 2018 and Oct 24, 2024 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RMT281414 AND PXC141000) WAS IMPLANTED ON (B)(6) 2014 IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURED 60 MM. DUE TO A TYPE 1A ENDOLEAK WITH AN ONSET DATE OF (B)(6) 2022, THE PATIENT RECEIVED A PROXIMAL EXTENSION USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER ENDOPROSTHESIS PLA320400) ON (B)(6) 2022. ON THE FOLLOW-UP EXAM ON (B)(6) 2022, THE ABDOMINAL AORTIC ANEURYSM OF 66 MM WAS MEASURED. ALL FOLLOW-UP EXAMS THEREAFTER MEASURED A DECREASE OF THE ANEURYSM SIZE (55 MM AS OF (B)(6) 2024).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20520957 ↗
• InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2012, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS RMT281414, A GORE® EXCLUDER® AAA ENDOPROSTHESIS PXC141200, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS PXC271000. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, FSA REPORTED THAT HE WAS DOING A CASE WITH A PHYSICIAN WHO NOTED THAT ONE OF HIS PATIENTS HAD A TYPE IB ENDOLEAK WHICH MAY REQUIRE REINTERVENTION IN THE FUTURE. PATIENT AND DEVICE INFORMATION WAS PROVIDED. THE PHYSICIAN HAD NOTED THE ENDOLEAK ON AN ANGIOGRAM, AND PERFORMED EMBOLIZATION OF THE LEFT INTERNAL ILIAC ON (B)(6) 2024. THE ENDOLEAK IS SCHEDULED TO BE TREATED IN ABOUT TWO WEEKS.

  Patient problems: Clinical Endoleak

  MAUDE report 19584618 ↗
• InjuryNov 17, 2023Migration; Migration

  ON (B)(6) 2014, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM RUPTURE, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RMT281414). ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS NOTED. ON (B)(6) 2018, REINTERVENTION SURGERY WAS PERFORMED . AORTIC EXTENDER WAS IMPLANTED. PATIENT TOLERATED THE PROCEDURE (CAPTURED IN PSTS# (B)(4)). ON (B)(6) 2023 AN ANGIOGRAM WAS PERFORMED, WHICH SHOWED A COMPONENT SEPARATION, TYPE 3 ENDOLEAK BETWEEN THE MOST DISTAL AORTIC EXTENDER (PLA SERIAL# REMAINS UNKNOWN) AND THE EXCLUDER MAIN BODY. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT. ON (B)(6) 2023, PATIENT UNDERWENT REINTERVENTION SURGERY, IN WHICH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) DEVICE WAS UTILIZED TO BRIDGE BETWEEN THE MAIN BODY AND THE AORTIC EXTENDER, TO EXCLUDE THE COMPONENT SEPARATION. PATIENT TOLERATED THE PROCEDURE. FSA REPORTS PHYSICIAN DOES NOT KNOW THE EXACT CAUSE OF TYPE 3 ENDOLEAK, BUT THERE WAS DISTAL MIGRATION (DISTANCE UNKNOWN) OF RMT281414. FSA ALSO REPORTS THE ABDOMINAL AORTA APPEARS TO HAVE LENGTHENED AND BECOME SOMEWHAT ANGLED, POSSIBLY CONTRIBUTING TO THE COMPONENT SEPARATION. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 18164847 ↗
• InjuryAug 11, 2023Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  ON (B)(6) 2013, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17511127 ↗
• InjuryMar 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THE PATIENT WAS TREATED FOR AN UNKNOWN ISSUE. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, A TYPE IA ENDOLEAK WAS DETECTED. THE PHYSICIAN IS UNSURE OF THE CAUSE OF THE ENDOLEAK. A REINTERVENTION IS PLANNED. IMAGES ARE AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 16619120 ↗
• InjuryMar 1, 2022Adverse 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 A 55MM MEASURED ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, THE ANEURYSM ENLARGED TILL 68MM. ON (B)(6) 2016, THE INFERIOR MESENTERIC ARTERY WAS EMBOLIZED DUE TO A TYPE II ENDOLEAK WITH A SAC ENLARGEMENT. THIS INFORMATION HAS BEEN ALREADY REPORTED. FOLLOW UP CTA FROM (B)(6) 2017 TILL (B)(6) 2019 SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 73MM TO 89MM. ON (B)(6) 2020, THE PATIENT UNDERWENT THE EXPLANT PROCEDURE TO TREAT THE ANEURYSM ENLARGEMENT (UNKNOWN AMOUNT) AND A TYPE II ENDOLEAK CAUSED BY THE FAILURE OF THE PREVIOUS EMBOLIZATION PROCEDURE. REPORTEDLY, THE AORTOILIAC BYPASS WAS PERFORMED. ACCORDING TO THE SITE, THE EVENT WAS RELATED TO BOTH AORTIC DEVICE AND PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13635209 ↗
• InjuryMay 5, 2021Migration; Migration

  ON (B)(6) 2011, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED FOUR GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE. ON 5-APR-2021, THE GORE FSA WAS SENT IMAGES BY A PHYSICIAN FOR A PATIENT THAT THEY WOULD LIKE CONSIDERED FOR THE (B)(6) TRIAL. THE RMT281414 HAD MIGRATED, AND WAS NOW LYING SIDEWAYS IN THE ANEURYSMAL SAC, RESULTING IN A TYPE IA ENDOLEAK. NO DECISION HAS BEEN MADE REGARDING REINTERVENTION AT THIS TIME. IMAGES WERE RETURNED FOR EVALUATION. THE EVALUATION STATED: THE PREVIOUSLY IMPLANTED ENDOGRAFT APPEARS TO BE APPROXIMATELY 45MM DISTAL TO THE LOWEST RENAL ARTERY. THE AORTIC DIAMETER JUST DISTAL TO THE LOWEST RENAL ARTERY ~ 42MM (AVERAGE) NO PRE-IMPLANTATION IMAGES ARE AVAILABLE TO ASSESS DIAMETERS AND LENGTHS. THE AORTA APPEARS TORTUOUS. THERE IS NO EVIDENCE OF GRAFT KINKING OR ABNORMALITY WITHIN THE GRAFT EXCLUDING THE FACT THAT IT APPEARS 4CM DISTAL TO THE LOWEST RENAL ARTERY. THE LEFT HYPO APPEARS TO HAVE BEEN COVERED DURING THE DEVICE PLACEMENT. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A TYPE 1B ENDOLEAK.

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

  MAUDE report 11777645 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN OFFICE STATED THAT THE DATE THE EVENT WAS IDENTIFIED WAS ON (B)(6) 2019 (THESE IMAGES ARE NOT AVAILABLE). ON (B)(6) 2019, THE PHYSICIAN REINTERVENED TO TREAT AN ENLARGING ABDOMINAL AORTIC ANEURYSM SECONDARY TO DISTAL MIGRATION OF PREVIOUS IMPLANTED AORTIC STENT GRAFT WITH A PROBABLE TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES, THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8992482 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2014, INFECTION OF THE RIGHT GROIN WOUND WAS IDENTIFIED. ON THE SAME DAY INCISION AND DRAINAGE OF THE RIGHT GROIN WOUND WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED TO GORE.

  Patient problems: Unspecified Infection

  MAUDE report 8812415 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK. DATE AND MODALITY OF IMAGES IS UNKNOWN. THE REASON FOR THE ENDOLEAK IS UNKNOWN. THE PHYSICIAN REINTERVENED ON (B)(6) 2019, AND IMPLANTED TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8649773 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THERE WERE TWO NON-GORE® BALLOON EXPANDABLE STENTS (BRAND IS UNKNOWN) IMPLANTED DISTAL TO THE GORE® EXCLUDER® LIMBS, ONE ON EACH SIDE. IT WAS REPORTED THAT ULTRASOUND IMAGES DATED ON (B)(6) 2018, REVEALED A POSSIBLE OCCLUDED LIMB ON THE LEFT SIDE OF THE IMPLANTED GRAFT. ON (B)(6) 2018, THE PHYSICIAN REINTERVENED AND DILATED THE RIGHT LIMB WITH A 12MMX4CM BALLOON AND DID A FEM-FEM BYPASS SURGERY. THE OCCLUDED LIMB WAS OCCLUDED FROM THE DISTAL END OF THE STENT ON THE LEFT LIMB UP TO THE FLOW DIVIDER OF THE RMT281414 DEVICE. THE FIELD SALES ASSOCIATE RECALLS THE PXC14122 DEVICE WAS ON THE LEFT SIDE ALSO AND OCCLUDED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8248735 ↗
• InjuryDec 11, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED A SUSPECTED PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS REPORTEDLY DUE TO DISTAL MIGRATION (AMOUNT UNKNOWN) OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE MIGRATION WAS REPORTED CAUSED BY DILATATION OF THE AORTIC NECK CAUSING A LOSS OF SEAL. ON (B)(6) 2018, A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED FOR PROXIMAL EXTENSION OFF OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8151632 ↗
• InjuryJun 29, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-OPERATIVE IMAGING REVEALED A MAXIMUM ANEURYSM DIAMETER OF 51 MM. DURING THE PROCEDURE, THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED. A TYPE II ENDOLEAK WAS OBSERVED AT TIME OF CLOSURE OF THE LAST ACCESS ROUTE. HOWEVER, NO TYPE II ENDOLEAK WAS NOTED ON (B)(6)2012, PRIOR TO HOSPITAL DISCHARGE DURING COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING. AT ONE MONTH FOLLOW-UP ON (B)(6) 2013, DOPPLER ULTRASOUND REVEALED A TYPE II ENDOLEAK. AT SIX MONTHS FOLLOW-UP ON (B)(6) 2013, CTA IMAGING REVEALED TYPE II ENDOLEAKS OF THE LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY WITH A STABLE 51 MM ANEURYSM DIAMETER. AT ONE YEAR FOLLOW-UP ON (B)(6) 2013, COMPUTED TOMOGRAPHY IMAGING CONFIRMED A MAXIMUM ANEURYSM DIAMETER OF 55 MM. ON THIS VISIT AS WELL AS ON (B)(6) 2014, THE TWO TYPE II ENDOLEAKS WERE FOUND TO PERSIST. ON (B)(6) 2018, CTA IMAGING SHOWED AN ANEURYSM DIAMETER OF 68 MM AND THE KNOWN TYPE II ENDOLEAKS. ON (B)(6) 2018, THE INFERIOR MESENTERIC ARTERY AS WELL AS THE ANEURYSM SAC WERE EMBOLIZED.

  Patient problems: No Code Available

  MAUDE report 7649562 ↗

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