GORE EXCLUDER AAA Endoprosthesis PXC141200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132609956), received between Sep 11, 2018 and Jul 31, 2025 — 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.

• InjuryJul 31, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND CONTRALATERAL LEG). ON (B)(6) 2025, A CTA WORK-UP REPORT WAS PROVIDED TO FIELD SALES ASSOCIATE SHOWING A GORE EXCLUDER DEVICE THAT HAS MIGRATED 26MM DISTALLY AND SHOWS OBSERVABLE EVIDENCE OF GRAFT INTEGRITY FAILURE (NITINOL FRACTURES WITH A DILATED PROXIMAL NECK). BILATERAL HYPOGASTRIC ARTERIES OCCLUDED NATIVELY WITH DISTAL RIGHT COMMON ILIAC ARTERY ANEURYSMAL AND THE RIGHT EXTERNAL ILIAC ARTERY IS CALCIFIED. PHYSICIAN PLANS TO DO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) REINTERVENTION AT SOME POINT (DATE NOT SCHEDULED YET) TO RELINE THE ORIGINAL GRAFTS WITH A CONFORMABLE TRUNK IPSILATERAL GRAFT AND A CONTRALATERAL LIMB IN OFF-LABEL USE DUE TO DILATED PROXIMAL NECK ANEURYSMAL. THE ANEURYSM GROWTH (SIZE UNKNOWN) IS DUE TO THE MIGRATION.

  Patient problems: Aneurysm expansion

  MAUDE report 22675199 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A CT IMAGING REVEALED ANEURYSM ENLARGEMENT APPROXIMATELY 20MM, AND A TYPE II ENDOLEAK FROM INFERIOR MESENTERIC ARTERY WAS SUSPECTED. IN (B)(6) 2020, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. (THIS EVENT WAS REPORTED UNDER (B)(4)). ON AN UNKNOWN DATE, A TYPE III ENDOLEAK (UNKNOWN WHETHER COMPONENT DISCONNECTION NOR TEAR/DISRUPTION IN GRAFT MATERIAL) AND A TYPE II ENDOLEAK WAS SUSPECTED FROM AN IMAGING. ON (B)(6) 2020, RE-INTERVENTION PLACING ADDITIONAL STENT GRAFT AT THE CONNECTION OF THE PXT261218 AND PXC141200 WAS PERFORMED. THE PHYSICIAN ELECTED TO MONITOR TYPE II ENDOLEAK, AND NO TREATMENT WAS PERFORMED FOR TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. (THIS EVENT WAS REPORTED UNDER (B)(4)). ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS OBSERVED, INFLAMMATORY ANEURYSM AND DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE WERE SUSPECTED ON THE COMPUTED TOMOGRAPHY ANGIOGRAPHY. ON (B)(6) 2024, A RE-INTERVENTION WAS PERFORMED, AFTER THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZ

  Patient problems: Aneurysm expansion

  MAUDE report 21146585 ↗
• InjuryJan 6, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A PXT261216 TRUNK-IPSILATERAL LEG COMPONENT AND PXC141200 CONTRALATERAL LEG COMPONENT WERE IMPLANTED. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POSSIBLE PROXIMAL TYPE I OR TYPE II ENDOLEAK AFFECTING THE PXT261216, AND A POSSIBLE DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. IT WAS NOTED THAT THE RIGHT ILIAC ARTERY WAS DILATED AND THE DEVICE WAS NOT OPPOSED TO THE VESSEL WALL. ANGIOGRAPHY WAS PERFORMED, AND A SMALL ENDOLEAK WAS OBSERVED PROXIMALLY. THE DEVICE WAS BALLOONED WITH A GORE® MOLDING & OCCLUSION BALLOON CATHETER. THE ENDOLEAK WAS STILL PRESENT SO A GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY. THE AORTIC EXTENDER WAS BALLOONED AND THE ENDOLEAK REMAINED. THE PHYSICIAN WAS REPORTEDLY UNABLE TO CONFIRM WHETHER THE ENDOLEAK WAS A PROXIMAL TYPE I OR TYPE II. THE PHYSICIAN EXTENDED THE DEVICE IN THE RIGHT COMMON ILIAC ARTERY USING ANOTHER DEVICE TO EXTEND INTO THE DISTAL COMMON ILIAC ARTERY. NO FURTHER ENDOLEAK WAS OBSERVED DISTALLY. THERE WERE NO FURTHER REPORTED ISSUED. THE PATI

  Patient problems: Clinical Endoleak

  MAUDE report 21086016 ↗
• InjuryApr 18, 2024Adverse 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 (AAA) AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS (CIAA). THE AAA WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESES (RLT261418/(B)(6)). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) THIS DATE DETERMINED THE AAA MAXIMUM DIAMETER MEASURED 68MM, THE LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) MAXIMUM DIAMETER MEASURED 60MM; AND THE RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA) MAXIMUM DIAMETER MEASURED 45MM. THE LCIAA WAS TREATED WITH A PXC141400/(B)(6) AND A PXC141200/ (B)(6) WITH EMBOLIZATION OF THE LIIA. THE RCIAA, THE IPSILATERAL SIDE WAS EXTENDED WITH A PXC141200/13972402 WITH COIL EMBOLIZATION OF RIIA. THE PATIENT IS REPORTED TO HAVE A MAXIMUM INFRARENAL NECK ANGLE OF 75 DEGREES, A PROXIMAL LANDING ZONE DIAMETER RANGING 23-19MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REPORTS THE MAXIMUM DIAMETER OF THE AAA MEASURED 63MM, THE MAXIMUM DIAMETER OF THE LCIAA MEASURED 41MM AND THE MAXIMUM DIAMETER OF THE RCIAA MEASURED 53MM. ON (B)(6) 2023, FOLLOW-UP CTA REPORTS THE MAXIMUM DIAMETER OF THE

  Patient problems: Rupture

  MAUDE report 19131074 ↗
• InjuryOct 20, 2022Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2016 WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT PRESENTED WITH COMPLETE THROMBOSIS OF THE CONTRALATERAL LEG ENDOPROSTHESIS (PLC141200) UP TO THE INTERNAL BIFURCATION OF THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT231416) AND PARTIAL THROMBOSIS OF THE IPSILATERAL LEG OF THE RLT231416. ADDITIONALLY, SOME THROMBUS FORMATION ABOVE THE BIFURCATION OF THE RLT231416 WAS NOTED. A REINTERVENTION TO RELINE THE IPSILATERAL LEG ON THE PATIENT'S RIGHT WAS PLANNED FOR (B)(6) 2022. THE PATIENT'S LEFT WILL NOT BE TREATED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15640118 ↗
• InjuryJun 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK IN THE RIGHT LEG WAS REPORTEDLY OBSERVED. THE CAUSE OF THE ENDOLEAK WAS NOT REPORTED. ON (B)(6) 2014, A REINTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND DISTALLY ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12005435 ↗
• InjuryAug 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2009 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS NOTED BY THE PHYSICIAN THAT THE LENGTH OF THE PATIENT'S LEFT COMMON ILIAC ARTERY WAS SHORT. ON AN UNKNOWN DATE A SUSPECTED DISTAL TYPE I ENDOLEAK ON THE CONTRALATERAL LEG COMPONENT, LOCATED ON THE PATIENT'S LEFT SIDE, AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) WERE OBSERVED. THE CLINICAL SALES ASSOCIATE STATED THAT THE DISTAL TYPE I ENDOLEAK WAS NOT CONFIRMED ON IMAGING AT THE TIME OF THE FOLLOW-UP VISIT, BUT IT WAS SUSPECTED THAT THE MINOR ENDOLEAK MAY HAVE BEEN PRESENT FROM THE INITIAL PROCEDURE DUE TO THE DIAMETER OF THE PATIENT'S LEFT COMMON ILIAC ARTERY HAVING ENLARGED WHERE THE DEVICE WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION. AN ADDITIONAL GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS USED TO EXTEND THE CONTRALATERAL LEG COMPONENT ON THE PATIENT'S LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10461368 ↗
• InjuryOct 25, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS LOST TO FOLLOW UP IN 2018, HOWEVER RETURNED FOR FOLLOW UP ON OR ABOUT (B)(6) 2019. COMPUTED TOMOGRAPHY REVEALED A POSTERIOR CONTRAST BLUSH. THE RADIOLOGIST INTERPRETED IT AS A TYPE II ENDOLEAK FROM AN INTERIOR MESENTERIC ARTERY. HOWEVER, THE PHYSICIAN DETERMINED IT TO BE A TYPE I DISTAL ENDOLEAK. IT APPEARED THAT THE LEFT CONTRALATERAL LEG COMPONENT DID NOT HAVE SUFFICIENT DISTAL SEAL. ON (B)(6) 2019, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT THE TYPE I DISTAL ENDOLEAK. AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC161000/20743849) WAS IMPLANTED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 9239923 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ISSUES. IT WAS REPORTED THAT THE DISTAL SEAL ZONE OF BOTH LEGS WAS SHORT (DISTANCE UNKNOWN). ON AN UNKNOWN DATE, LATE FOLLOW- UP POST-OPERATIVE IMAGING IDENTIFIED ENLARGEMENT OF THE ANEURYSM. THE AMOUNT OF ENLARGEMENT WAS UNKNOWN. NO ENDOLEAK WAS OBSERVED AT THIS TIME AND THE CAUSE OF ANEURYSM ENLARGEMENT WAS UNABLE TO BE DETERMINED. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND ADDITIONAL DEVICES WERE IMPLANTED TO EXTEND THE LEGS ON BOTH SIDES. FINAL ANGIOGRAPHY SHOWED NO ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8504831 ↗
• InjuryFeb 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A TYPE II ENDOLEAK WAS REPORTEDLY IDENTIFIED ORIGINATING FROM A RIGHT ILIOLUMBAR ARTERY OCCURRING VIA A RIGHT INTERNAL ILIAC ARTERY. REPORTEDLY, NO ANEURYSM ENLARGEMENT WAS NOTED. IT WAS REPORTED, THAT THE LANDING ZONE FOR THE ORIGINAL IMPLANTED CONTRALATERAL LEG COMPONENT WAS SHORT. ON (B)(6) 2019, A REINTERVENTION TO TREAT THE TYPE II ENDOLEAK WAS REPORTEDLY PERFORMED. IT WAS REPORTED, THE PHYSICIAN PERFORMED A COIL EMBOLIZATION PROCEDURE OF THE RIGHT INTERNAL ILIAC ARTERY. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS ALSO REPORTEDLY USED TO EXTEND INTO THE PATIENT¿S EXTERNAL ILIAC ARTERY. IT WAS REPORTED, THE ENDOLEAK WAS RESOLVED. NO FURTHER ISSUES WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8302313 ↗
• InjurySep 11, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT281418/(B)(4), PXL161407/(B)(4), PLA280300/(B)(4), PXC141400/(B)(4), AND PXC141200/(B)(4)) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK WITH ANEURYSMAL ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2018, THE PATIENT UNDERWENT COIL-EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT THE TYPE II ENDOLEAK. HOWEVER, THE ENDOLEAK REPORTEDLY REMAINED AFTER THE PROCEDURE. ON (B)(6) 2015, A TYPE II ENDOLEAK ORIGINATING FROM THE IMA AND LUMBAR ARTERIES WAS CONFIRMED BY COMPUTED TOMOGRAPHIC ANGIOGRAPHY. ON THIS DATE, THE PATIENT UNDERWENT AN OPEN PROCEDURE WHEREBY THE STENT GRAFT COMPONENTS WERE EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND, THEREFORE, WERE NOT AVAILABLE FOR ANALYSIS BY GORE.

  Patient problems: No Code Available

  MAUDE report 7865536 ↗

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