GORE EXCLUDER AAA Endoprosthesis PXT231216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132610112), received between Oct 3, 2018 and Jun 12, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2013, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER ALL DEVICES WERE IMPLANTED, A TYPE II ENDOLEAK WAS OBSERVED. HOWEVER, NO TREATMENT FOR THE TYPE II ENDOLEAK WAS PERFORMED AND THE PROCEDURE WAS CONCLUDED. ON (B)(6) 2017, THE INFERIOR MESENTERIC ARTERY WAS LIGATED AND ANEURYSMORRHAPHY WAS PERFORMED BY THE OPEN SURGERY BECAUSE OF THE TYPE II ENDOLEAK FROM THE IMA WITH THE ANEURYSM ENLARGEMENT WAS CONFIRMED. AFTER THE REINTERVENTION ON (B)(6) 2017, IT WAS UNKNOWN IF THERE WAS ANY ENDOLEAK, BUT THE ANEURYSM WAS ENLARGED. ON (B)(6) 2023, NO ENDOLEAK WAS OBSERVED, BUT GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED PROXIMALLY OF THE TRUNK AND DISTALLY OF BOTH LEGS. AFTER ALL DEVICES WERE IMPLANTED, NO ENDOLEAK WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17108474 ↗
• InjuryNov 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  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. ON (B)(6) 2022, THE PHYSICIAN REPORTED THE PATIENT HAS A SUSPECTED DISTAL TYPE I ENDOLEAK ASSOCIATED WITH THE GORE® EXCLUDER® TRUNK IPSILATERAL LEG ON THE RIGHT SIDE. THE PATIENT UNDERWENT REINTERVENTION THIS DATE AND CONTRALATERAL LEG COMPONENT WAS IMPLANTED ON THE RIGHT SIDE TO EXTEND COVERAGE. THE PHYSICIAN NOTED THAT IMAGING SHOWED AN ENDOLEAK BUT IT DID NOT APPEAR TO COMMUNICATE WITH THE ANEURYSM SAC. THE PHYSICIAN REPORTED ANEURYSM ENLARGEMENT BUT THE AMOUNT WAS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 15820836 ↗
• InjuryOct 16, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2008 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 THE PATIENT PRESENTED WITH A POSSIBLE ENDOLEAK ACCORDING TO ULTRASOUND DIAGNOSIS. THE PHYSICIAN COMPLETED AN ANGIOGRAM THAT DID NOT IDENTIFY AN ENDOLEAK. REPORTEDLY THE DEVICE APPEARED TO BE IN GOOD POSITION FROM THE ORIGINAL REPAIR, AND THE ANEURYSM SAC SIZE APPEARED TO BE STABLE. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED POSSIBLE ENDOTENSION. THE DECISION WAS MADE TO RELINE THE ORIGINAL IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY 4 APTUS ENDOANCHOR DEVICES WERE PLACED AT THE PROXIMAL PORTION OF THE ORIGINAL TRUNK-IPSILATERAL LEG COMPONENT. THE DEVICE WAS THEN RELINED WITH A PLA230300 AORTIC EXTENDER COMPONENT WHICH WAS PLACED ABOVE THE FLOW DIVIDER OF THE ORIGINAL MAIN BODY. BOTH LIMBS WERE ALSO RELINED. A PLC141400 CONTRALATERAL LEG COMPONENT WAS USED TO RELINE THE ORIGINAL IPSILATERAL LIMB, LOCATED ON THE PATIENT'S RIGHT SIDE. A PLC121400 CONTRALATERAL LEG COMPONENT WAS USED TO RELINE THE ORIGINAL CONTRALATERAL LEG COMPONENT LOCATED ON THE PATIENT'S LEFT SIDE. IT WAS REPORTED THAT IMPLANTATION WAS COMPLETED WITHOUT INC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9200357 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, AN ULTRASOUND DATED (B)(6) 2019, REVEALED ANEURYSM ENLARGEMENT (5.8CM TO 6.3CM). FOLLOW UP COMPUTED TOMOGRAPHY (DATE UNKNOWN) REVEALED THE PATIENT HAD A TYPE I ENDOLEAK WITH DISTAL MIGRATION OF THE PROXIMAL NECK OF THE GRAFT (AMOUNT OF MIGRATION IS UNKNOWN). THE PHYSICIAN REINTERVENED ON (B)(6) 2019, AND IMPLANTED A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8628348 ↗
• InjuryOct 24, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE (PATIENT LOST TO FOLLOW-UP), THE PATIENT REPORTEDLY UNDERWENT A RE-INTERVENTION(S) TO TREAT A TYPE II ENDOLEAK. IT WAS ALSO REPORTED THE PATIENT LATER REFUSED TREATMENT OF A SUSPECTED TYPE I ENDOLEAK. ON (B)(6) 2018, PRESENTED TO THE HOSPITAL WITH A RUPTURED AORTIC ANEURYSM. IT WAS REPORTED THE RUPTURE WAS TREATED WITH AN OPEN PROCEDURE SURGICAL REPAIR PLACING A "TUBE GRAFT¿ BETWEEN THE RENAL ARTERIES AND EXCLUDER LIMBS. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Perforation of Vessels

  MAUDE report 8002261 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, THE PATIENT WAS REPORTED TO HAVE A TYPE II ENDOLEAK. THE ANEURYSM SAC WAS REPORTED TO MEASURE 10CM. ON (B)(6) 2018, THE PATIENT UNDERWENT EXPLANT OF THE DEVICES AND SURGICAL REPAIR OF THE ABDOMINAL AORTA. IT WAS REPORTED THAT THE SOURCE OF THE TYPE II ENDOLEAK WAS MULTIPLE LUMBAR ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED AT THE SITE.

  Patient problems: Aneurysm

  MAUDE report 7931207 ↗

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)