GORE EXCLUDER AAA Endoprosthesis PLA230300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132618750), received between Apr 20, 2021 and Nov 14, 2025 — classified as 2 deaths, 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER AND GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDERS TO TREAT A THORACIC DISSECTION IN ZONE 2 THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT SUFFERED PARALYSIS POST PROCEDURE. REPORTEDLY, THE PATIENT PRESENTED ON (B)(6) 2025, WITH CHEST PAIN AND LEG WEAKNESS, SHE DEVELOPED NEUROLOGIC CHANGES AND REQUIRED INTUBATION AND EVENTUALLY WAS FOUND TO HAVE TYPE B DISSECTIONS WITH MASSIVE MALPERFUSION, VISCERAL RENAL AND LOWER EXTREMITY MALPERFUSION AND POSSIBLY SPINAL MALPERFUSION FROM THE COMPLICATED DISSECTION. TREATMENT FOR THE PARALYSIS ON (B)(6) 2025, PERMISSIVE HYPERTENSION AND LEFT UPPER EXTREMITY SPINAL DRAIN PLACEMENT. POST REINTERVENTION ON (B)(6) 2025, THE PATIENT WAS ABLE TO MOVE THE RIGHT UPPER EXTREMITY AND NOT THE LOWER EXTREMITIES AND HAS BEEN MOVED TO A REHABILITATION FACILITY.

  Patient problems: Vascular Dissection

  MAUDE report 23560380 ↗
• MalfunctionJan 7, 2025Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. WHEN DELIVERING A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT PLA230300 BELOW THE LEFT RENAL ARTERY, THE DISTAL PORTION REPORTEDLY SEPARATED. SUBSEQUENTLY, THE DEVICE WAS RETRIEVED FROM THE PATIENT, RESULTING IN PROLONGED OPERATIVE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089262 ↗
• InjuryApr 15, 2024Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY ARE UNKNOWN) REVEALED A PROXIMAL TYPE 1 ENDOLEAK. THERE WAS ANEURYSM ENLARGEMENT (2.2CM) REPORTED. THE PHYSICIAN STATED THE POSSIBLE ROOT CAUSE OF THE ENDOLEAK WAS DISTAL MIGRATION (DISTANCE UNKNOWN); HOWEVER, THERE ARE NO IMAGES TO SUPPORT THIS. ON (B)(6) 2024, A REINTERVENTION OCCURRED. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER) AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THERE WAS NO TORTUOSITY, CALCIUM OR THROMBUS IN THE PATIENT¿S AORTIC ANATOMY.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19109897 ↗
• InjuryApr 11, 2024Migration; Migration

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PRIOR ENDOVASCULAR REPAIR WITH A MEDTRONIC AFIX GRAFT AND A VELA CUFF. GORE® EXCLUDER®AAA ENDOPROSTHESIS WERE IMPLANTED TO TREAT A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE MEDTRONIC DEVICES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER MEASURED 52MM. ON AN UNKNOWN DATE ESTIMATED TO BE ON OR ABOUT (B)(6) 2023, THE PATIENT WAS DETERMINED TO HAVE A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIIA) AND A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE PROXIMAL GRAFTS. ON (B)(6) 2024, THE PATIENT UNDERWENT ADDITIONAL ENDOVASCULAR OF A SUSPECTED PROXIMAL TYPE AND TREATMENT OF THE RCIAA, TWO GORE® EXCLUDER® AORTIC EXTENDERS WERE IMPLANTED PROXIMALLY AND THE RCIAA WAS COIL EMBOLIZED AND EXTENDED DISTALLY WITH A GORE® EXCLUDER® ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE WITH NO ENDOLEAK CONFIRMED, AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024 IN STABLE CONDITION.

  Patient problems: Aneurysm expansion

  MAUDE report 19093775 ↗
• InjuryFeb 6, 2024Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESES (ONE RLT DEVICE & TWO PLC DEVICES). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED WITH INVAGINATION OF THE PREVIOUSLY PLACED RLT DEVICE IN THE INFRARENAL AORTA AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLA). THE PLA DEVICE WAS IMPLANTED SUCCESSFULLY, AND THE INVAGINATION WAS RESOLVED BY COVERAGE FROM THE PLA DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT REPORTED TO GORE THAT THEIR KIDNEYS HAD BEEN OCCLUDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN BUT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE REINTERVENTION EVENT FROM MEDICAL RECORDS ON JANUARY 11, 2024: ON (B)(6) 2022, DURING THE REINTERVENTION PROCEDURE, ANGIOGRAM WAS DONE THAT SHOWED THE TRUNK IPSILATERAL GRAFT HAD FOLDED ON ITSELF IN THE INFRARENAL AORTA AND RESULTED IN A NEAR OCCLUSION AND THERE WAS SEVERE STENOSIS IN THE LEFT LIMB (GORE® EXCLUDER® AAA ENDOPROSTHESIS, CONTRALATERAL LEG, PLC16L400). TO RESOLVE THE INFOLDING, A

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 18655773 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER WAS 52MM. FROM (B)(6) 2015 TO (B)(6) 2017 THE MAXIMUM AORTIC DIAMETER DECREASED FROM 49.8MM TO 45MM. ON (B)(6) 2018, THE MAXIMUM AORTIC DIAMETER WAS 49MM AND LATER, DECREASED IN SIZE TO 45MM ON (B)(6) 2021. REPORTEDLY, ON (B)(6) 2023, A PROXIMAL TYPE I ENDOLEAK WAS DETERMINED. ACCORDING TO THE SITE A CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS AN EXCESSIVE INFRARENAL NECK ANGULATION AND AN AORTIC NECK DILATION (AND). ACCORDING TO THE SITE, THE EVENT WAS NOT DEVICE OR PROCEDURE RELATED. THE PHYSICIAN CONFIRMED THAT THE PROGRESSION OF THE ANEURYSMAL DISEASE AND THE EXCESSIVE PROXIMAL NECK ANGULATION CAUSED THE ENDOLEAK AND PROCEDURAL ISSUES. THERE WAS NO ANEURYSM ENLARGEMENT NOTICED FROM (B)(6) 2018. THE PHYSICIAN IS MONITORING THE PATIENT AND IS PLANNING A PROXIMAL TYPE I ENDOLEAK REPAIR WITH AN AORTIC CUFF. PROCEDURE IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Clinical Endoleak

  MAUDE report 17579302 ↗
• DeathJun 12, 2023Adverse 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) 2023, BILATERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE LEFT AND RIGHT COMMON ILIAC ARTERIES TO TREAT AN AORTOILIAC ANEURYSM. THE PHYSICIAN INITIATED THE PROCEDURE WITH ENDOVASCULAR LITHOTRIPSY BILATERALLY IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES WITH A SHOCKWAVE DEVICE. THE VBX DEVICES WERE IMPLANTED WITHOUT DIFFICULTY OR COMPLICATIONS. AFTER POST DILATION A FINAL CTA WAS RUN THAT INDICATED A BLEED IN THE AORTA. AT THAT TIME A GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS IMPLANTED FOR A ZONE 9 INFRARENAL DISSECTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT EXPIRED. MORE INFORMATION IS BEING OBTAINED INCLUDING WHEN AND HOW THE PATIENT EXPIRED AND IF THE PATIENT'S DEATH WAS GORE DEVICE RELATED.

  Patient problems: Vascular Dissection

  MAUDE report 17111997 ↗
• InjuryMay 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2023, THE GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS WAS EXPLANTED. REASON FOR EXPLANT IS UNKNOWN.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 16870966 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH GORE® AORTIC EXTENDER ENDOPROSTHESIS WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2021, POST PROCEDURE THE PATIENT EXPERIENCED SPINAL CORD ISCHEMIA. TREATMENT WAS A LUMBAR DRAIN AND MEDICATION. THE PATIENT TOLERATED THE PROCEDURE AND THE SPINAL CORD ISCHEMIA RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 14731627 ↗
• InjuryAug 4, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2016 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A PENETRATING AORTIC ULCER USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE BILATERAL GROIN HEMATOMAS. BILATERAL FEMORAL ARTERY EXPLORATION AND REPAIR WAS PERFORMED.

  Patient problems: Hematoma

  MAUDE report 12274381 ↗
• DeathJun 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RIGHT COMMON ILIAC ARTERY ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ON (B)(6) 2015. ON (B)(6) 2017, THE PATIENT PRESENTED WITH AN AORTO-ENTERIC FISTULA AND RELATED GRAFT INFECTION. THE DEVICES WERE EXPLANTED, AND A BOWEL RESECTION WAS DONE. THE PATIENTS DIED ON (B)(6) 2017, DUE TO A SEPTIC PROBLEM.

  Patient problems: Bacterial Infection; Fistula

  MAUDE report 11918737 ↗
• InjuryApr 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICE WAS FULLY DEPLOYED, AND A BALLOON WAS USED TO HELP SEAT THE GRAFT. IN DOING SO, THE AORTA RUPUTURED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED TO COVER THE RUPTURED AREA. BECAUSE OF THE LOCATION OF THE RUPTURE, THE RIGHT RENAL WAS COVERED BY THE EXCLUDER. THE PATIENT TOLERATED THE PROCEDURE. THE AORTA WAS HEAVILY CALCIFIED IN THE AREA OF THE IMPLANT, AND IT IS BELIEVED THE PHYSICIAN OVERINFLATED THE BALLOON, CAUSING THE RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695370 ↗

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