GORE EXCLUDER AAA Endoprosthesis PXT231416Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132610150), received between Sep 14, 2018 and Oct 17, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 17, 2025Adverse 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) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DEVICES WERE DEPLOYED WITH BILATERAL COMMON ILIAC ARTERY LANDING. ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEFT INTERNAL ILIAC ARTERY ANEURYSM, ADDITIONAL STENT GRAFTS WERE IMPLANTED. AN ULCER-LIKE PROJECTION (ULP) WAS OBSERVED AT THE DISTAL END OF THE RIGHT COMMON ILIAC ARTERY, BUT NO INTERVENTION WAS PERFORMED AT THAT TIME. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION DUE TO ENLARGEMENT OF THE ULP AT THE DISTAL END OF THE RIGHT COMMON ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED WITH PLUGS, AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED EXTENDING INTO THE RIGHT EXTERNAL ILIAC ARTERY. ATTENDING PHYSICIAN¿S COMMENT: ULP WAS ALSO OBSERVED IN THE DESCENDING AORTA, SUGGESTING THE POSSIBILITY OF AN UNDERLYING PATHOLOGICAL VASCULAR CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 23320535 ↗
• InjuryNov 13, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2005, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT231416, PXL161407, AND PXC161000 WERE IMPLANTED). ON AN UNKNOWN DATE, AND ENDOLEAK WAS OBSERVED. THE TYPE OF ENDOLEAK AND LOCATION OF ENDOLEAK REMAINS UNKNOWN. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THIS ENDOLEAK. PHYSICIAN RELINED AN EXCLUDER GRAFT. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20674811 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED DUE TO A TYPE IB ENDOLEAK OF THE LEFT SIDE (PXC141000) AND ANEURYSM ENLARGEMENT WHICH WERE FOUND DURING A FOLLOW-UP EXAMINATION. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED IN THE LEFT SIDE AND THE ENDOLEAK DISAPPEARED. ALSO, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED IN THE RIGHT SIDE (DISTAL TO PXT231416) AS WELL TO PREVENT TYPE IB ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19727845 ↗
• InjuryJul 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS OBTAINED FROM PROGRAM AND ABSTRACTS OF THE 29TH ANNUAL MEETING OF THE JAPANESE SOCIETY OF ENDOVASCULAR INTERVENTION. NORIHIRO ANDO, ET AL. FOUR CASES THAT REQUIRED OPEN SURGERY AFTER ENDOVASCULAR AORTIC REPAIR. THE AUTHORS REPORT ON 4 CASES OF ANEURYSM ENLARGEMENT OR RUPTURE DUE TO ENDOLEAK (EL) FOLLOWING ENDOVASCULAR AORTIC REPAIR (EVAR) THAT REQUIRED OPEN SURGERY. THE CASES WERE FOUR MALE PATIENTS IN THEIR 70S OR 80S. TWO WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND THE OTHER TWO WERE TREATED WITH MEDTRONIC ENDURANT. IN 2 EXCLUDER CASES AND 1 ENDURANT CASE, ANEURYSM ENLARGEMENT DUE TO TYPE II EL OCCURRED, AND TRANSARTERIAL LUMBAR ARTERY EMBOLIZATION AND PERCUTANEOUS LUMBER ARTERY EMBOLIZATION WERE PERFORMED; HOWEVER, THE ENLARGEMENT CONTINUED AND THUS, SURGICAL ANEURYSMORRHAPHY WAS PERFORMED. AFTER THE SURGERY, ANEURYSM SHRINKAGE WAS SHOWN IN 2 CASES. ALTHOUGH FURTHER ENLARGEMENT WAS NOTED IN 1 CASE, IT STOPPED 2 YEARS LATER.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17421015 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, A TYPE I ENDOLEAK WAS DISCOVERED ON FOLLOW UP. THE PHYSICIAN ATTRIBUTES THE ENDOLEAK TO A COMBINATION OF DISEASE PROGRESSION AND SEVERE ANGULATED AORTIC NECK. ON (B)(6) 2022, A REINTERVENTION OCCURRED WHEREBY AN AORTIC EXTENDER COMPONENT (CXA260005/23237966) WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14788781 ↗
• InjuryApr 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2007, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES, ONE IN THE LCIA AND ONE IN THE RCIA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN PERFORMED A REINTERVENTION, AFTER FOLLOW UP SHOWED ANEURYSM ENLARGEMENT ON BOTH SIDES. HE BELIEVES DISEASE PROGRESSION CAUSED THE ENLARGEMENT, AS NO ENDOLEAKS WERE FOUND. HE IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AS WELL AS EMBOLIZING THE LCIA. THE PATIENT TOLERATED THE PROCEDURE. IMAGES WERE RECEIVED AND EVALUATED.

  Patient problems: Aneurysm

  MAUDE report 14252073 ↗
• InjuryJan 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH 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). THERE IS ANEURYSM SAC ENLARGEMENT REPORTED (AMOUNT IS UNKNOWN). THE CAUSE FOR THE TYPE I ENDOLEAK IS UNKNOWN. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND IMPLANTED A PALMAZ STENT (50X10) AND BALLOONED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11219795 ↗
• InjurySep 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. DURING THE INITIAL PROCEDURE, A TYPE II ENDOLEAK ORIGINATING FROM THE LUMBAR ARTERY WAS OBSERVED. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE ANEURYSM ENLARGED TO 80 MM. ON (B)(6) 2020, THIS PATIENT UNDERWENT A REINTERVENTION. INTRAOPERATIVE ANGIOGRAPHY REVEALED TYPE II ENDOLEAKS, AND A POSSIBLE TYPE I ENDOLEAK. THE POSSIBLE TYPE I ENDOLEAK WILL BE MONITORED. AFTER LIGATION OF THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY, THROMBECTOMY INSIDE THE ANEURYSM SAC, AND ANEURYSM PLICATION WERE PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 10574496 ↗
• InjurySep 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. DURING THE INITIAL PROCEDURE, A TYPE II ENDOLEAK ORIGINATING FROM THE LUMBAR ARTERY WAS OBSERVED. THE ENDOLEAK WAS MONITORED. IT WAS REPORTED THE DIAMETER OF THE ANEURYSM WAS 61 MM. ON AN UNKNOWN DATE IN (B)(6) 2015, IT WAS REPORTED THE ANEURYSM HAD GRADUALLY ENLARGED (AMOUNT UNKNOWN). THEREFORE, THE EMBOLIZATION OF THE LUMBAR ARTERY WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 10574158 ↗
• InjuryAug 27, 2020Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON (B)(6) 2009 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, PROXIMAL MIGRATION (DISTANCE UNKNOWN) OF THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT LOCATED ON THE PATIENT'S RIGHT SIDE, AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) WERE OBSERVED. THE PHYSICIAN STATED THAT APPROXIMATELY 10 YEARS AFTER THE INITIAL PROCEDURE IT WAS NOTED THAT THE VESSEL DIAMETER WHERE THE IPSILATERAL LIMB WAS LOCATED HAD ENLARGED, AND THE LIMB MIGRATED. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION. A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS USED TO EXTEND THE IPSILATERAL LEG DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10460907 ↗
• InjuryApr 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT IS UNKNOWN IF THE PATIENT'S COMMON ILIAC ARTERIES WERE ANEURYSMAL. ON AN UNKNOWN DATE, THE IMAGING IDENTIFIED THAT THE DISTAL OF THE LEFT COMMON ILIAC ARTERY BECAME AN ANEURYSMAL. ON (B)(6) 2019, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE LEFT COMMON ILIAC ARTERY ANEURYSM. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE TO EXTEND COVERAGE OF THE IPSILATERAL LEG DISTALLY.

  Patient problems: Aneurysm

  MAUDE report 8514586 ↗
• InjuryJan 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, FOLLOW UP FILMS WERE READ THAT REVEALED A LARGE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2018, A REINTERVENTION OCCURRED WHEREBY ADDITIONAL GORE® DEVICES WERE IMPLANTED TO TREAT THE ENDOLEAK. THREE GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESES WERE IMPLANTED IN THE RENAL ARTERIES AS PART OF A SNORKEL PROCEDURE, THEN THREE GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS WERE IMPLANTED PROXIMALLY TOWARDS THE SUPERIOR MESENTERIC ARTERY TO TREAT THE TYPE I ENDOLEAK. THE ENDOLEAK WAS SUCCESSFULLY TREATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212608 ↗
• InjurySep 14, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT HAD A SIGNIFICANT AORTIC NECK ANGLE APPROXIMATELY 2-3 CM BELOW THE LOWEST RENAL ARTERY. ON (B)(6) 2018, DURING FOLLOW UP ANGIOGRAPHY, IT WAS SUSPECTED THAT THE AORTIC NECK OF THE TRUNK-IPSILATERAL LEG COMPONENT HAD INFOLDED. THIS DIAGNOSIS WAS CONFIRMED ON A CTA PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAS SOME THROMBUS AND CLAUDICATION IN THE LOWER LIMBS. A REINTERVENTION IS PLANNED FOR (B)(6) 2018.

  Patient problems: Atrial Perforation

  MAUDE report 7877873 ↗

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)