GORE EXCLUDER AAA Endoprosthesis PLA320400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132618804), received between Aug 30, 2018 and May 18, 2023 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT HAD PRIOR EVAR ON (B)(6) 2021 AT AN OUTSIDE FACILITY (B)(6) MEDICAL CENTER). A RLT311417 AND PLC141200 WERE IMPLANTED. A REINTERVENTION WAS PERFORMED ON (B)(6) 2022 AT THE SAME FACILITY FOR AN ASSUMED TYPE 1A ENDOLEAK AS THREE PROXIMAL CUFF DEVICES WERE IMPLANTED (PLA320400, CXA320005, CXA360005). I FOUND OUT TODAY THAT THE PATIENT WAS TRANSFERRED OVER THE WEEKEND TO (B)(6) MEDICAL CENTER AND THE DEVICES WERE EXPLANTED BY DR. (B)(6) DUE TO A CONTINUED TYPE 1A ENDOLEAK. THE PT HAD BEEN HAVING ABDOMINAL AND BACK PAIN THAT GOT PROGRESSIVELY WORSE OVER THE PAST FEW DAYS UNTIL IT BECAME UNBEARABLE. THE EXPLANT PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Clinical Endoleak

  MAUDE report 16957109 ↗
• InjuryNov 30, 2022Leak/Splash; Migration; Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ON AN UNSPECIFIED DATE IN 2004 THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH A NON-GORE (MEDTRONIC) GRAFT. ON (B)(6) 2013, THE PATIENT UNDERWENT A REINTERVENTION TO ADDRESS A MIGRATION OF THE NON-GORE (MEDTRONIC) DEVICE THAT HAD BEEN PREVIOUSLY IMPLANTED. TWO GORE® EXCLUDER®AAA ENDOPROSTHESIS AORTIC EXTENDERS WERE IMPLANTED. AS REPORTED, ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE PREVIOUSLY IMPLANTED MEDTRONIC GRAFT HAD MIGRATED RESULTING IN A TYPE III ENDOLEAK BETWEEN THE MEDTRONIC AND THE GORE® EXCLUDER®AAA ENDOPROSTHESIS AORTIC EXTENDERS. AS REPORTED, ON (B)(6) 2022, THE PATIENT UNDERWENT A REINTERVENTION IN WHICH THE IMPLANTED GRAFT WAS RELINED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AS REPORTED THERE WAS PARTIAL COVERAGE OF THE LEFT RENAL WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AS REPORTED THE PHYSICIAN STENTED WITH A VBX. IT WAS NOT CLEAR WHICH OF THE GORE® EXCLUDER®AAA ENDOPROSTHESIS AORTIC EXTENDERS WAS PLACED ADJACENT TO THE NON-GORE DEVICE. IMAGING IS AVAILABLE ON THE CLOUD FOR CONSIDERATION.

  Patient problems: Clinical Endoleak

  MAUDE report 15890283 ↗
• InjuryJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: PHYSICIAN REPORTED PATIENT HAS PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE, POSSIBLE REINTERVENTION TO OCCUR OVER THE WEEKEND. THAT'S ALL THE INFORMATION I HAVE AT THIS TIME, JUST NEED TO KNOW WHAT DEVICES ARE IMPLANTED IN THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 14567783 ↗
• InjuryMay 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, THE PATIENT HAD A REINTERVENTION TO TREAT A PROXIMAL TYPE I ENDOLEAK FROM THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (PSTS EVENT #35806). THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, ANOTHER REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE I ENDOLEAK. TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A TORTUOUS AORTA, WHICH MAY HAVE LED TO THE ENDOLEAKS.

  Patient problems: Insufficient Information

  MAUDE report 14399585 ↗
• InjuryJun 30, 2021Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PLA320400 / 22903558 WAS RETURNED TO TILBURG WAREHOUSE FOR FURTHER PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094412 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE PROXIMAL TYPE I OR TYPE II ENDOLEAK (DATE AND MODALITY OF IMAGES IS UNKNOWN) AND THE PHYSICIAN WANTED TO REINTERVENE. THERE IS ANEURYSM SAC ENLARGEMENT REPORTED (AMOUNT IS UNKNOWN). THE PHYSICIAN DETERMINED THAT IT WAS A PROXIMAL TYPE I ENDOLEAK AND DURING REINTERVENTION PLACED 12 APTUS SCREWS IN THE AREA OF THE PROXIMAL NECK OF THE INITIAL GRAFT (PLA320400/18785494). IN ADDITION, THE PHYSICIAN PLACED A PALMAZ STENT (P4010) IN THE AREA AS WELL TO TREAT THE ENDOLEAK. UPON COMPLETION OF THIS INTERVENTION, THE ENDOLEAK WAS SUCCESSFULLY TREATED AND THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Aneurysm

  MAUDE report 10691998 ↗
• InjuryJun 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PROXIMAL PLACEMENT OF THE TRUNK IPSILATERAL LEG COMPONENT WAS LANDED APPROXIMATELY 2 CM BELOW THE LOWEST (ACCESSORY) RENAL ARTERY. ON (B)(6) 2018, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS WERE PLACED PROXIMALLY TO EXTEND COVERAGE OF THE TRUNK AND RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION DUE TO EXPANSION OF THE ANEURYSM SAC AND A GORE® AORTIC EXTENDER COMPONENT WAS IMPLANTED TO RELINE THE PROXIMAL END. THE CAUSE OF THE ENLARGEMENT WAS NOT DETERMINED; A TYPE II ENDOLEAK WAS SUSPECTED HOWEVER NO VISIBLE ENDOLEAK WAS DETERMINED BY CONTRAST IMAGING AT THE TIME. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION DUE TO ONE OF THE AORTIC EXTENDER COMPONENT APPEARING TO HAVE A DISTAL BIRD BEAK AND THE PATIENT WAS EXPERIENCING BELLY PAIN. AN ADDITIONAL AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY AND

  Patient problems: Aneurysm

  MAUDE report 10169401 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, 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) 2020, REVIEW OF FOLLOW-UP IMAGING DETERMINED WHAT APPEARS TO BE A COMPONENT SEPARATION BETWEEN THE DISTAL AORTIC EXTENDER COMPONENT AND THE MAIN BODY OF THE TRUNK IPSILATERAL LEG COMPONENT. THE OVERLAP ZONE OF THE DEVICES APPEARED TO BE APPROPRIATE. ADDITIONAL TREATMENT IS REQUIRED ON A DATE NOT YET SPECIFIED.

  Patient problems: Aneurysm

  MAUDE report 10070649 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (SIZE UNKNOWN) USING FOUR NON-GORE DEVICES AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. IT WAS REPORTED THE GORE® EXCLUDER® DEVICE WAS IMPLANTED INTO THE NON-GORE MAIN BODY DEVICE IN THE PROXIMAL NECK. THERE IS NO REPORT OF ANY ADDITIONAL GORE DEVICES BEING IMPLANTED AT THIS TIME. ON (B)(6) 2016, FOLLOW UP IMAGING REPORTEDLY IDENTIFIED A TYPE II ENDOLEAK WITH THE ANEURYSM MEASURING 47 MM. IT WAS REPORTED THE ENDOLEAK WAS ¿NOT A TRUE ENDOLEAK, BUT RATHER NON-THROMBOSED SAC.¿ ON (B)(6) 2017, FOLLOW UP IMAGING REPORTEDLY AGAIN IDENTIFIED A TYPE II ENDOLEAK, ALONG WITH A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THE ANEURYSM MEASURED 56 MM. ACCORDING TO THE SITE, THE TYPE II ENDOLEAK WAS ORIGINATING FROM AN ELEMENT OF THE SAC NOT FULLY THROMBOSED, TRACKING TO LUMBAR ARTERIES AND A VERY LARGE INFERIOR MESENTERIC ARTERY. IT WAS REPORTED THE DISTAL TYPE I ENDOLEAK WAS ASSOCIATED WITH ONE OF THE NON-GORE DEVICES AND WAS REPORTEDLY CAUSED BY ¿ENLARGEMENT OF THE COMMON ILIAC ARTERIES, DUE TO EXTREME HYPERTENSION THAT DAY.¿ BETWEEN (B)(6) 2018 AND (B)(6) 2019, FOLLOW-UP EXAMINATIONS REVEALED T

  Patient problems: No Code Available

  MAUDE report 9671486 ↗
• MalfunctionJan 7, 2020Difficult to Insert; Mechanical Problem; Difficult to Remove; Difficult to Insert; Mechanical Problem; Difficult to Remove

  IT WAS REPORTED THAT A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS (PLA) WAS ADVANCE OVER A 0.35¿ LUNDERQUIST GUIDEWIRE OUTSIDE OF THE PATIENT AND GOT STUCK ON THE GUIDEWIRE DURING AN IMPLANT PROCEDURE. FURTHER ADVANCEMENT INTO THE PATIENT WAS NOT POSSIBLE. IT WAS STATED THAT THE GUIDEWIRE WAS WIPED WITH A WET GAUZE AND THE DEVICE WAS FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE PREVIOUSLY. DURING A FORCEFUL ATTEMPT TO REMOVE THE DEVICE OF THE GUIDEWIRE THE PROXIMAL OLIVE OF THE PLA BECAME DETACHED. THE ISSUE HAD NO REPORTED EFFECTS ON THE PATIENT AND THE IMPLANT PROCEDURE WAS COMPLETED AS PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558153 ↗
• InjuryMar 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT, ON (B)(6) 2019, THE PLA320400 AORTIC EXTENDER COMPONENT (LOT #17619304) WAS EXPLANTED FROM THE PATIENT'S ILIAC ARTERY. REPORTEDLY THE DEVICE WAS EXPLANTED DUE TO RAPID EXPANSION OF THE ILIAC ARTERY, AND A PERSISTENT TYPE IB ENDOLEAK. THE ILIAC ARTERY WAS REPORTED TO HAVE EXPANDED 5MM IN A ONE MONTH TIME PERIOD. IT WAS NOTED THAT THE ILIAC ARTERY EXPANSION WAS SUSPECTED TO BE CAUSED BY A CONNECTIVE TISSUE DISORDER. REPORTEDLY THE PHYSICIAN DID NOT SUSPECT THE CONNECTIVE TISSUE DISORDER TO BE PRE-EXISTING. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT A TRUNK-IPSILATERAL LEG COMPONENT AND FOUR CONTRALATERAL LEG COMPONENTS WERE USED IN THE INITIAL PROCEDURE ON (B)(6) 2018. PRIOR TO THE REPORTED EXPLANT, IT WAS ESTABLISHED THAT AN ADDITIONAL PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO PLACE AN ADDITIONAL CONTRALATERAL LEG COMPONENT. THIS PROCEDURE WAS NOT REPORTED TO GORE. THE LOCATION OF THE ADDITIONAL CONTRALATERAL LEG IMPLANTATION WAS NOT REPORTED. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT, IN ADDITION TO THE AORTIC EXTE

  Patient problems: Aneurysm

  MAUDE report 8434180 ↗
• InjuryFeb 13, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PHYSICIAN HAD CHOSEN NOT TO PERFORM ANGIOPLASTY AS THE PATIENT¿S ASCENDING AND PROXIMAL MID DESCENDING THORACIC AORTA; DOWN TO THE BILATERAL COMMON ILIAC ARTERIES WERE REPORTED TO HAVE MULTIPLE SITES OF SPONTANEOUS CHRONIC ARTERIAL DISSECTIONS. ADDITIONALLY, IT WAS REPORTED THAT PATIENT¿S AORTIC NECK LENGTH ONLY MEASURED 8-9MM. INTRAPROCEDURE IMAGING SHOWED A PROXIMAL TYPE I ENDOLEAK AND A GORE® EXCLUDER® AORTIC EXTENDER WAS IMPLANTED WITH CAREFUL ANGIOPLASTY OF THE PROXIMAL END. IMAGING AT THIS TIME SHOWED THE ENDOLEAK HAD BEEN RESOLVED HOWEVER THAT THE AORTIC EXTENDER COMPONENT HAD COMPLETELY COVERED THE LEFT RENAL ARTERY. ATTEMPTS TO MANEUVER THE AORTIC EXTENDER COMPONENT WERE MADE BUT NOT SUCCESSFUL. A LEFT RENAL ARTERY TO LEFT EXTERNAL ARTERY TRANSPOSITION WAS THEN PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8336381 ↗
• InjuryAug 30, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, FOLLOW UP IMAGING DETERMINED A PROXIMAL TYPE I ENDOLEAK DUE TO DISEASE PROGRESSION OF THE PROXIMAL AORTA AND A LACK OF CIRCUMFERENTIAL APPOSITION OF THE MOST PROXIMAL DEVICE; A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT. ENLARGEMENT OF THE ANEURYSM WAS ALSO REPORTED HOWEVER THE AMOUNT IS UNKNOWN AS THE DIAMETER AT THE TIME OF INITIAL IMPLANT IS UNKNOWN. THE DIAMETER AT FOLLOW UP IMAGING WAS REPORTED TO BE 5 CM. THE PATIENT IS BEING MONITORED BY THE PHYSICIAN AND NO REINTERVENTION IS PLANNED AT THIS TIME.

  Patient problems: Aneurysm

  MAUDE report 7834273 ↗

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