GORE EXCLUDER AAA Endoprosthesis PXT281212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132610259), received between May 26, 2023 and Jun 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (PXT281212) WAS DEPLOYED, AND ITS IPSILATERAL LEG WAS EXTENDED BY A CONTRALATERAL LEG ENDOPROSTHESIS (PXC181000). ANOTHER CONTRALATERAL LEG ENDOPROSTHESIS (PXC201400) WAS DEPLOYED AS A CONTRALATERAL LIMB. AS THE PXC201400 LANDED ON A TIGHTLY CURVED LEFT COMMON ILIAC ARTERY, IT WAS REINFORCED BY A CORDIS PALMAZ® STENT. THE FINAL ANGIOGRAPHY CONFIRMED A TYPE ENDOLEAK, WHICH WAS DECIDED TO BE MONITORED AND LEFT UNTREATED. THE PATIENT TOLERATED THE PROCEDURE. (REF. (B)(4)) ON (B)(6) 2015, REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE ENDOLEAK. WHILE SECURING THE LEFT RENAL FLOW BY USING A BOSTON SCIENTIFIC EXPRESS¿ VASCULAR SD AS A CHIMNEY GRAFT, AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDED TO THE PROXIMAL END OF THE PREVIOUSLY IMPLANTED PXT281212. THE FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. (REF. (B)(4)) ON AN UNKNOWN DATE AROUND 2021, A FOLLOW-UP EXAMINATION CONFIRMED AN UNKNOWN AMOUNT OF ANEURYSM ENLARGEMENT. AS TREATMENT, THE PATIENT UNDERWENT AN OPEN VASCULA

  Patient problems: Aneurysm

  MAUDE report 17037059 ↗
• InjuryMay 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (PXT281212) WAS DEPLOYED, AND ITS IPSILATERAL LEG WAS EXTENDED BY A CONTRALATERAL LEG ENDOPROSTHESIS (PXC181000). ANOTHER CONTRALATERAL LEG ENDOPROSTHESIS (PXC201400) WAS DEPLOYED AS A CONTRALATERAL LIMB. AS THE PXC201400 LANDED ON A TIGHTLY CURVED LEFT COMMON ILIAC ARTERY, IT WAS REINFORCED BY A CORDIS PALMAZ® STENT. THE FINAL ANGIOGRAPHY CONFIRMED A TYPE ENDOLEAK, WHICH WAS DECIDED TO BE MONITORED AND LEFT UNTREATED. THE PATIENT TOLERATED THE PROCEDURE. (REF. MPDCASE-(B)(4)) ON (B)(6) 2015, REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE ENDOLEAK. WHILE SECURING THE LEFT RENAL FLOW BY USING A BOSTON SCIENTIFIC EXPRESS¿ VASCULAR SD AS A CHIMNEY GRAFT, AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDED TO THE PROXIMAL END OF THE PREVIOUSLY IMPLANTED PXT281212. THE FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS. THE REPORTING PHYSICIAN STATED THAT THE PROXIMAL TYPE I ENDOLEAK WAS PREDICTABLE AS THE PATIENTS¿ INFRARENAL NECK LENGTH WAS SHORT AND THE PROXIMAL LANDING ZONE WAS SHORTER THAN WHAT WAS REQUIRED IN THE

  Patient problems: Aneurysm

  MAUDE report 17008916 ↗

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