GORE EXCLUDER AAA Endoprosthesis PXC121000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132609918), received between Jan 2, 2019 and Sep 27, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT311413/15200324, PXC121400/15426697, PXC121000/15426697, PLC201000/13722896). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT WAS EVALUATED FOR TYPE II ENDOLEAK, HOWEVER, THE PATIENT DID NOT RETURN FOR ANY FOLLOW-UPS. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT UNDERWENT EMBOLIZATION FOR A TYPE II ENDOLEAK. THE PROCEDURE WAS NOT SUPPORTED BY A GORE ASSOCIATE. ON (B)(6) 2024, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) COUPLED WITH A RUPTURING ABDOMINAL AORTIC ANEURYSM INTO THE RETROPERITONEUM. THE PATIENT UNDERWENT SURGICAL CONVERSION AND THE TRUNK IPSILATERAL COMPONENT AND PORTIONS OF THE CONTRALATERAL LIMBS IN THE DISTAL AORTA WERE CUT OFF AND EXPLANTED. A SURGICAL GRAFT WAS THEN PLACED AND SEWED TO THE DISTAL PORTIONS OF THE GRAFTS LEFT IN PLACE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. THIS PROCEDURE WAS NOT SUPPORTED BY A GORE ASSOCIATE.

  Patient problems: Aneurysm expansion

  MAUDE report 20327533 ↗
• InjurySep 3, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2005, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, A DISTAL TYPE I ENDOLEAK WAS OBSERVED ON THE CONTRALATERAL LEG COMPONENT. LACK OF DISTAL DEVICE SEAL WAS REPORTED AS THE CAUSE OF THE ENDOLEAK. AN INTERVENTION IS PLANNED, BUT HAS NOT YET BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353687 ↗
• InjuryDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNSPECIFIED DATE IN 2002 THE PATIENT WAS IMPLANTED WITH A NON-GORE AORTIC TRUNK DEVICE (ANCURE) FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011 THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER (PXL161407). ON (B)(6) 2013 A REINTERVENTION OCCURRED IN WHICH THE EXISTING CONFIGURATION, INCLUDING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER, WAS RELINED WITH THE FOLLOWING GORE DEVICES: 3 GORE® EXCLUDER AORTIC EXTENDER ENDOPROSTHESIS (PXA230300), 1 GORE® EXCLUDER CONTRALATERAL LEG ENDOPROSTHESIS (PXC121000), AND 1 GORE® ILIAC EXTENDER ENDOPROSTHESIS (PXL161207). THE SPECIFIC REASON FOR THE REINTERVENTION IS UNKNOWN. ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE IB ENDOLEAK. IT IS UNKNOWN WHEN THE ENDOLEAK WAS FIRST IDENTIFIED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. AS REPORTED THERE WAS OBSERVED DILATION ON THE LEFT COMMON ILIAC. COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC WAS PERFORMED AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC121400) WAS LANDED IN THE LEFT EXTERNAL ILIAC IN ORDER TO ADDRESS THE ENDOLEAK AND EXTEND COVERAGE. A LACK OF CIRCUMFERENTIAL SEAL WAS NOTED IN

  Patient problems: Aneurysm

  MAUDE report 13048830 ↗
• InjuryApr 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ENLARGEMENT OF THE PATIENT'S RIGHT COMMON ILIAC ARTERY WAS OBSERVED. IT WAS REPORTED THAT A DISSECTION WAS NOTED EXTENDING FROM AN UNIDENTIFIED LOCATION AROUND THE DISTAL END OF THE CONTRALATERAL LEG COMPONENT LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. REPORTEDLY, THE PHYSICIAN SUGGESTED THAT THE DISSECTION NEAR THE DISTAL END OF THE DEVICE MAY BE THE CAUSE OF THE ILIAC ARTERY ENLARGEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION. THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. AN ADDITIONAL CONTRALATERAL LEG COMPONENT AND A CORDIS S.M.A.R.T. STENT WERE PLACED TO THE LEVEL OF THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY, INTENTIONALLY COVERING THE EMBOLIZED RIGHT INTERNAL ILIAC ARTERY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11616785 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THIS SAME DAY THAT A CONTRALATERAL LEG COMPONENT WAS EXPLANTED/DESTROYED THIS DATE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 9521888 ↗
• InjuryJun 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW UP IMAGING DETERMINED A POSSIBLE UNKNOWN ENDOLEAK. IMAGES WERE PROVIDED TO GORE AND AN EVALUATION SHOWED THE FOLLOWING: IMAGES PROVIDED ARE POST-IMPLANT CTA DATED (B)(6) 2019, ARTERIAL PHASE. A NON-CONTRAST PHASE WAS SUBMITTED BUT MISSING IMAGES, ONLY A COUPLE ARE PROVIDED FOR COMPARISON. THERE APPEARS TO BE A LACK OF WALL APPOSITION AT THE DISTAL END OF THE DEVICE ON THE RIGHT. THERE APPEARS TO BE CONTRAST POOLING OUTSIDE OF THE DISTAL END OF THE DEVICE ON THE RIGHT. THERE APPEARS TO BE CONTRAST POOLING IN THE SAC AT THE LEVEL OF THE IMPLANTED DEVICE. THERE APPEARS TO BE PATENT LUMBAR PRESENT AT THE LEVEL OF THE IMPLANTED DEVICE. THIS MAY OR MAY NOT BE ASSOCIATED WITH A POSSIBLE TYPE II ENDOLEAK. FINDINGS ARE CONSISTENT WITH A DISTAL TYPE I ENDOLEAK. ON (B)(6) 2019 THE PATIENT UNDERWENT A REINTERVENTION TO TREAT THE DISTAL TYPE I ENDOLEAK. COILS WERE PLACED IN THE RIGHT INTERNAL ILIAC ARTERY, AND A CONTRALATERAL LEG COMPONENT (PLC1612007/18460915) WAS PLACED AS AN EXTENSION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745602 ↗
• InjuryJan 2, 2019Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A TYPE II ENDOLEAK WAS REPORTEDLY IDENTIFIED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-WATCH APPROACH IN REGARD TO THE TYPE II ENDOLEAK AND COMPLETED THE PROCEDURE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE ANEURYSM WAS ENLARGED DUE TO THE TYPE II ENDOLEAK ORIGINATING FROM THE VASA VASORUM. A DISTAL TYPE I ENDOLEAK SECONDARY TO PROXIMAL MIGRATION OF THE CONTRALATERAL LEG COMPONENT (B)(4) ON THE RIGHT SIDE WAS ALSO REPORTEDLY IDENTIFIED. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED, AND AN ADDITIONAL EXCLUDER® CONTRALATERAL LEG COMPONENT WAS IMPLANTED DISTALLY ON THE RIGHT SIDE TO TREAT THE DISTAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED. DURING THE SAME PROCEDURE, THE PHYSICIAN REPORTEDLY MADE AN ATTEMPT TO APPROACH THE VASA VASORUM THROUGH THE ANEURYSM TO TREAT THE TYPE II ENDOLEAK, BUT THE APPROACH WAS UNSUCCESSFUL. THE PHYSICIAN ABORTED TREATMENT OF THE TYPE II ENDOLEAK AND WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8208645 ↗

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