GORE EXCLUDER AAA Endoprosthesis PXT281416Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610310), received between Aug 11, 2018 and Aug 24, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2021Adverse 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) 2021 THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A SUSPECTED ENDOLEAK OF UNKNOWN ORIGIN WHEREBY AN ILIAC EXTENDER (PLC161200/21808672A) WAS PLACED TO EXTEND THE TRUNK-IPSILATERAL LEG COMPONENT TO THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12360121 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAS SIGNIFICANT MIGRATION OF HER GORE® EXCLUDER® AAA ENDOPROSTHESES (COMPUTED TOMOGRAPHY DATED (B)(6) 2021). THE ANEURYSM STARTS ALMOST IMMEDIATELY BELOW THE RENAL ARTERIES. THERE IS NO ANEURYSM SAC ENLARGEMENT. A FUTURE REINTERVENTION IS BEING CONSIDERED, UTILIZING A FENESTRATED/BRANCH GRAFT (NON GORE DEVICE) REPAIR. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 11645899 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES (DATE IS UNKNOWN) REVEALED THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT281416/7302070) HAD MIGRATED DISTALLY (AMOUNT OF MIGRATION IS UNKNOWN). THE CAUSE OF THE MIGRATION APPEARS TO BE DISEASE PROGRESSION, REPORTEDLY THE ANEURYSM SAC HAS ENLARGED PROXIMALLY (AMOUNT OF ENLARGEMENT IS UNKNOWN) OF THE RENAL ARTERIES. THE PATIENT IS NOT AN ENDOVASCULAR CANDIDATE. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 11311328 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2021, THIS PATIENT UNDERWENT REINTERVENTION FOR A COMMON ILIAC ARTERY ANEURYSM AND A DILATED INTERNAL ILIAC ARTERY. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND COVERAGE ON THE LEFT IPSILATERAL SIDE DOWN TO THE LEVEL OF THE INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11303101 ↗
• InjuryOct 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON OCTOBER 25, 2019 THE PHYSICIAN REPORTED TO THE FIELD SALES ASSOCIATE THAT THE MOST RECENT IMAGING FOR THE PATIENT STILL SHOWED CONTRAST IN THE ANEURYSM SAC. DATE OF IMAGING WAS REPORTED AS (B)(6), 2019. THE PHYSICIAN WAS REPORTEDLY UNABLE TO DETERMINE IF THE CONTRAST IN THE ANEURYSM SAC WAS RELATED TO THE PREVIOUSLY TREATED PROXIMAL TYPE I ENDOLEAK, OR IF IT WAS DUE TO A TYPE II ENDOLEAK ORIGINATING FROM A SMALL BUT PATENT INFERIOR MESENTERIC ARTERY NEAR THE SAME AREA. NO ANEURYSM ENLARGEMENT WAS REPORTED. THE ANEURYSM SAC WAS REPORTEDLY 7.8CMX9.3CM. AN ANEURYSM SAC ANALYSIS WAS REQUESTED. NO PLANS FOR REINTERVENTION WERE REPORTED. A DIAGNOSTIC ANGIOGRAM WAS REPORTEDLY PLANNED. ON (B)(6), 2019 A DIAGNOSTIC ANGIOGRAM WAS PERFORMED. A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY WAS CONFIRMED. IT WAS REPORTED THAT AN EMBOLIZATION WILL BE PERFORMED AT A LATER DATE. THE DATE OF PROCEDURE HAS REPORTEDLY NOT BEEN DETERMINED YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9183017 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THIS PROCEDURE, THE INFERIOR MESENTERIC ARTERY WAS COIL EMBOLIZED INTENTIONALLY. ON AN UNKNOWN DATE IN (B)(6) 2019 ((B)(6) 2019 WILL BE USED AS DATE OF EVENT), IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK, AT THE DISTAL END OF THE IPSILATERAL LEG OF THE ENDOPROSTHESIS. THE PHYSICIAN SUGGESTED THAT THE DISTAL TYPE I ENDOLEAK OCCURRED DUE TO THE PROXIMAL MIGRATION OF THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (DISTANCE IS UNKNOWN). ON (B)(6) 2019, AN ADDITIONAL TREATMENT WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK. A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED FOR DISTAL EXTENSION ON THE ALREADY IMPLANTED IPSILATERAL LEG ENDOPROSTHESIS AND BALLOONING WAS PERFORMED SEVERAL TIMES TO BOND TIGHTLY THE ENDOPROSTHESIS TO THE BLOOD VESSEL WALL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8563010 ↗
• InjuryAug 11, 2018Adverse 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) 2007 A PATIENT UNDERWENT TREATMENT WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TRUNK IPSILATERAL LEG COMPONENT (PXT281416/04779224) AND A CONTRALATERAL LEG COMPONENT (PXC141000/04777940). ON (B)(6) 2007, THE PATIENT WENT IN FOR A SECOND PROCEDURE TO PLACE AN AORTIC EXTENDER (PXA2803000/04702076).(CAPTURED EVENT # (B)(6)). ON (B)(6) 2018, A REINTERVENTION TOOK PLACE TO TREAT DISEASE PROGRESSION NOTED IN THE LEFT COMMON ILIAC ARTERY. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS UTILIZED TO TREAT THIS. IT WAS NOT POSSIBLE TO PRESERVE THE INTERNAL ILIAC ARTERY, HOWEVER THERE WERE NO REPORTED PROBLEMS WITH THE DEVICE ITSELF, SO THIS VESSEL WAS COIL EMBOLIZED. THE RIGHT COMMON ILIAC WAS SLIGHTLY ANEURYSMAL BUT IT WAS DECIDED NOT TO TREAT THIS AREA AT THIS TIME.

  Patient problems: Aneurysm

  MAUDE report 7775175 ↗

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