GORE EXCLUDER AAA Endoprosthesis PXT261218Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610204), received between Oct 18, 2018 and Mar 18, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (4 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.

• InjuryMar 18, 2024Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER THE INITIAL PROCEDURE, THE PATIENT WAS FOLLOWED UP AT ANOTHER HOSPITAL AND ANEURYSM ENLARGEMENT WAS NOTED; HOWEVER, HE REFUSED FURTHER TREATMENT AND THE ANEURYSM ENLARGEMENT WAS LEFT AS IT WAS. EVENTUALLY, THE ANEURYSM SIZE REACHED 10 CM, AND THE PATIENT VISITED THE REPORTING HOSPITAL. A PLAIN CT SCAN SHOWED DISTAL MIGRATION OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PATIENT WAS EXPLAINED ABOUT THE TREATMENT AGAIN AND AGREED TO RECEIVING ENDOVASCULAR REPAIR. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN ANGIOGRAPHY SHOWED DISTAL MIGRATION OF THE DEVICE BUT NO OBVIOUS ENDOLEAK WAS FOUND. AN ADDITIONAL AORTIC EXTENDER WAS DEPLOYED PROXIMAL TO THE PREVIOUS DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 18923786 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A TYPE II ENDOLEAK ORIGINATED FROM THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY WAS OBSERVED. ON (B)(6) 2014, A REINTERVENTION TOOK PLACE, BOTH THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY WERE EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12447103 ↗
• InjuryMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AFTER PROCEDURE IMAGES CONFIRMED THAT THERE WAS NO COMPLICATIONS OR ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, DURING A CONTROL CT SCAN, IT WAS OBSERVED THAT THE ANEURYSMATIC SAC HAD INCREASED (UNKNOWN AMOUNT). ALSO, A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2016, THE ENDOLEAK WAS EMBOLIZED. ON AN UNKNOWN DATE, ALMOST 3 YEARS AFTER EMBOLIZATION PROCEDURE, THE PATIENT PRESENTED WITH AN ABDOMINAL PAIN. DURING ANOTHER IMAGE EXAM, IT WAS NOTED THAT THE ANEURYSM HAD INCREASED IN SIZE (UNKNOWN AMOUNT) AND THE PATIENT WAS SUBMITTED TO ANOTHER PROCEDURE. REPORTEDLY, ON (B)(6) 2019, AN AORTIC CUFF WAS IMPLANTED. ON AN UNKNOWN DATE IN 2020, THE PATIENT WAS HOSPITALIZED DUE TO A STRONG ABDOMINAL PAIN. IT WAS REPORTED THAT THE ANEURYSM INCREASED TOO MUCH, AND THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A MEDTRONIC DEVICE (PROXIMAL REINFORCEMENT THROUGH ANCHORS). AS THERE WAS NO SIGN OF THE ANEURYSM BEING REDUCED, THE PHYSICIAN DID NOT BELIEVE THAT THERE WAS A POSSIBILITY OF TYPE I , TYPE II OR TYPE III ENDOLEAKS. THE PHYSICIAN SUSPECT

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

  MAUDE report 11780295 ↗
• InjurySep 3, 2020Migration; Migration

  FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, A 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. (ABOVE EVENT WAS REPORTED UNDER MPDCASE-(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 A IMAGING. ON (B)(6) 2020, RE-INTERVENTION PLACING ADDITIONAL STENT GRAFT AT THE CONNECTION OF THE (B)(4) WAS PERFORMED. THE PHYSICIAN ELECTED TO MONITOR TYPE II ENDOLEAK, AND NO TREATMENT WAS PERFORMED FOR TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10488929 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, A 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.

  Patient problems: Aneurysm

  MAUDE report 10486080 ↗
• InjuryJan 14, 2020Migration; Migration

  ON (B)(6) 2005, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW-UP COMPUTED TOMOGRAPHY ILLUSTRATES APPROXIMATELY 18MM DISTAL MIGRATION OF THE DEVICE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REINTERVENTION AND A MEDTRONIC CUFF WAS PLACED PROXIMALLY. ON (B)(6) 2019, COMPUTED TOMOGRAPHY IMAGES SHOW A TYPE III ENDOLEAK AND A SLIGHT SEPARATION OF THE EXCLUDER DEVICE AND THE MEDTRONIC DEVICE. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY TO REGAIN PROXIMAL SEAL AND TREAT THE ENDOLEAK. ADDITIONALLY, TWO CONTRALATERAL LEG COMPONENTS WERE PLACED ON EITHER SIDE TO ENSURE COVERAGE OF THE DISCONNECT AREA OF THE TYPE III ENDOLEAK. IT WAS REPORTED THAT DEGENERATION OF THE PATIENT'S PROXIMAL AORTIC NECK WAS ALSO A FACTOR. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 9587858 ↗
• InjuryDec 16, 2019Migration; Migration

  ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW-UP EXAMINATIONS WERE PERFORMED AT A REFERRING HOSPITAL. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE REFERRING HOSPITAL WITH ABDOMINAL PAIN AND TRANSFERRED TO THIS HOSPITAL. ON THE SAME DAY, COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY WAS PERFORMED, AND IT REVEALED 2-3 CM DISTAL MIGRATION OF THE PROXIMAL PORTION OF THE ENDOPROSTHESIS, A PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT (FROM 75 MM TO 82 MM). THE PHYSICIAN REPORTED THAT DETAILED COURSE AFTER THE INITIAL PROCEDURE AND THE CAUSE OF THESE ISSUES WERE UNKNOWN. DIAGNOSIS OF IMPENDING RUPTURE WAS MADE, AND IT WAS DECIDED TO PERFORM EMERGENCY PROCEDURE. TWO AORTIC EXTENDER COMPONENTS WERE ADDITIONALLY IMPLANTED PROXIMAL TO THE PREVIOUSLY IMPLANTED ENDOPROSTHESIS, AND FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9477288 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING IDENTIFIED A SUSPECTED ENDOLEAK (TYPE UNKNOWN) WITH AN UNKNOWN AMOUNT OF ANEURYSM ENLARGEMENT. ON (B)(6) 2018, IMAGING REPORTEDLY IDENTIFIED A TYPE II ENDOLEAK. ON THE SAME DAY, IT WAS REPORTED THE TRUNK-IPSILATERAL LEG COMPONENT WAS RELINED WITH A CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7980076 ↗

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