GORE EXCLUDER AAA Endoprosthesis PLA360400Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00733132618439), received between Jun 26, 2018 and Dec 21, 2025 — classified as 5 deaths, 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PATIENT WAS TO BE IMPLANTED WITH A GORE EXCLUDER TO EXTEND ABDOMINAL STENT GRAFT (CUFF) DURING TREATMENT OF ABDOMINAL AORTIC ANEURYSM PROCEDURE. THE PATIENT'S ILIAC ARTERY WAS DISTORTION, SO THE SHEATH WAS WITHDRAWN TO THE COMMON ILIAC ARTERY. CUFF DELIVERY WAS PERFORMED, AND SIGNIFICANT RESISTANCE WAS FOUND DURING THE DELIVERY PROCESS. PHYSICIAN PREPARED TO WITHDRAW THE CUFF AND SHEATH. DURING THE WITHDRAWAL PROCESS, IT WAS FOUND THAT THE CUFF HAD PARTIALLY DEPLOYED IN EXTERNAL ILIAC ARTERY WITHOUT INITIATING DEPLOYMENT. PHYSICIAN SUCCESSFULLY REMOVED THE CUFF AND SHEATH. THE PATIENT TOLERATED THE PROCEDURE AND SAFELY RETURNED TO WARD AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861275 ↗
• DeathApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT TREATMENT OF ABDOMINAL AORTIC ANEURYSM RUPTURE WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT351414/11417444). ON AN UNKNOWN DATE, A PROXIMAL TYPE I ENDOLEAK WAS DISCOVERED. ON (B)(6) 2017, THE PATIENT UNDERWENT A PLANNED REINTERVENTION AND TWO GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS (PLA360400/13671846, PLA360400 / (B)(6) WERE IMPLANTED PROXIMALLY TO EXTEND COVERAGE. IT IS UNKNOWN IF THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2019, FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 78.2MM. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REPORTS A PROXIMAL TYPE I ENDOLEAK NOT RELATED TO THE DEVICE OR PROCEDURE. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 147.0MM, THE PATIENT WAS SCHEDULED FOR A PROCEDURE AT A FUTURE DATE HOWEVER IT WAS CANCELLED BY THE PATIENT WHO EXPRESSED NO ADDITIONAL PROCEDURES WERE WANTED. ON (B)(6) 2024, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH A RUPTURED ANEURYSM AND THE FAMILY OPTED FOR COMFORT CARE ONLY. THE PATIENT EXPIRED IN THE ER.

  Patient problems: Rupture

  MAUDE report 21739696 ↗
• DeathMar 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM RUPTURE UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA IN ZONE 9. IT WAS REPORTED THAT THE PATIENT PRESENTED SYMPTOMATIC OF A RUPTURED ANEURYSM. HIS LEFT RENAL WAS INTENTIONALLY COVERED BECAUSE THE ANEURYSM EXTENDED TO THE LEFT RENAL. ALSO, TWO CONTRALATERAL LEGS WERE PLACED IN THE PATIENT. A FINAL ANGIOGRAM WAS PERFORMED THAT SHOWED NO EVIDENCE OF ENDOLEAK AND THE CONTAINMENT OF THE ANEURYSM SAC. THE RIGHT RENAL WAS FUNCTIONAL WITH NO ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT'S RENAL FUNCTION DECLINED. THE PHYSICIAN PERFORMED AN OPEN RENAL REVASCULARIZATION WITH ENDOSCOPIC INTERVENTION. THE PHYSICIAN ALSO PERFORMED A LAPAROTOMY. AT SOME POINT DURING THESE PROCEDURES, AN AORTIC EXTENDER AND NON-GORE BARE METAL STENT WAS PLACED IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), THE FSA WAS IN COMMUNICATION WITH THE PHYSICIAN. THE PHYSICIAN STATED THE PATIENT EXPIRED. THE EXACT EXPIRATION DATE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21733601 ↗
• DeathJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT ADMITTED TO THE EMERGENCY DEPARTMENT AND WAS UNSTABLE. AFTER IMPLANTING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, A TYPE I ENDOLEAK WAS PRESENT. MULTIPLE AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO TRY TO RESOLVE THE ENDOLEAK. THE PROXIMAL TYPE I ENDOLEAK REMAINED AND THE PHYSICIAN CHOSE TO CONVERT TO AN OPEN REPAIR. DURING THE OPEN REPAIR THE PATIENT CODED AND COULD NOT BE REVIVED. THE PATIENT EXPIRED DURING THE OPEN REPAIR. THE PHYSICIAN REPORTED THAT TOO MUCH BLOOD HAD BEEN LOST AND THERE WAS A RUPTURE AT THE RENAL ARTERIES. IT IS UNKNOWN IF THE IMPLANT OF ONE OF THE GORE ENDOPROSTHESIS CAUSED THE RUPTURE AT THE RENAL ARTERIES. THE FSA WAS NOT PRESENT AT THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19543320 ↗
• DeathJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT ADMITTED TO THE EMERGENCY DEPARTMENT AND WAS UNSTABLE. AFTER IMPLANTING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, A TYPE I ENDOLEAK WAS PRESENT. MULTIPLE AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO TRY TO RESOLVE THE ENDOLEAK. THE PROXIMAL TYPE I ENDOLEAK REMAINED AND THE PHYSICIAN CHOSE TO CONVERT TO AN OPEN REPAIR. DURING THE OPEN REPAIR THE PATIENT CODED AND COULD NOT BE REVIVED. THE PATIENT EXPIRED DURING THE OPEN REPAIR. THE PHYSICIAN REPORTED THAT TOO MUCH BLOOD HAD BEEN LOST AND THERE WAS A RUPTURE AT THE RENAL ARTERIES. IT IS UNKNOWN IF THE IMPLANT OF ONE OF THE GORE ENDOPROSTHESIS CAUSED THE RUPTURE AT THE RENAL ARTERIES. THE FSA WAS NOT PRESENT AT THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19543195 ↗
• InjuryMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD AN EXTREMELY ANGULATED AORTIC NECK. WHILE DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS THE DEVICE MIGRATED APPROXIMATELY 5MM BELOW THE LEFT RENAL ARTERY (LOWEST RENAL ARTERY). THIS RESULTED IN A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED A CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS TO TREAT THE ENDOLEAK. THE DEVICE ALSO MIGRATED DISTALLY INTO THE PROXIMAL PORTION INSIDE THE NECK OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. THE PROXIMAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN IMPLANTED A SECOND AORTIC EXTENDER ENDOPROSTHESIS AND BALLOONED. THERE WAS A SLIGHT BLUSHING DURING THE FINAL ANGIOGRAM, THE PROXIMAL TYPE I ENDOLEAK REMAINED. REPORTEDLY, THE FINAL ANGIOGRAPHY IMAGES WERE POOR QUALITY DUE TO THE PATIENT¿S OBESITY. BOTH A PROXIMAL TYPE I AND A DISTAL TYPE I ENDOLEAK REMAINED. ONE UNIT OF BLOOD WAS GIVEN DURING THE PROCEDURE DUE TO THE RUPTURED ANEURYSM UPON

  Patient problems: Clinical Endoleak

  MAUDE report 19374093 ↗
• InjuryAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY ANGIOGRAPHY WHICH DETERMINED ENLARGEMENT OF THE ANEURYSM TO 37MM AND A SMALL PROXIMAL TYPE I ENDOLEAK DUE TO DILATION OF THE AORTA AT THE LEVEL OF THE RENAL ARTERIES. ON (B)(6) 2023, THE PATIENT IS SCHEDULED TO UNDERGO PLACEMENT OF A PHYSICIAN MODIFIED GRAFT TO TREAT THE ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE OR WILL BE PROVIDED AS IT IS A NON-GORE PROCEDURE AT THE UNIVERSITY OF FLORIDA HOSPITAL AND WILL NOT BE SUPPORTED BY GORE.

  Patient problems: Aneurysm expansion

  MAUDE report 17482192 ↗
• InjuryMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A PREVIOUS TREATMENT FOR A TYPE I ENDOLEAK (MANUFACTURER UNKNOWN). THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. REPORTEDLY, PRE-TREATMENT ULTRASOUND SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 134MM. ON (B)(6) 2016, A PERSISTENT TYPE I ENDOLEAK WAS IDENTIFIED. NO TREATMENT HAS BEEN REPORTED TO GORE. REPORTEDLY, FROM (B)(6) 2016, THE ANEURYSM DECREASED IN SIZE FROM 157MM TO 154.7MM. ON (B)(6) 2019, IT WAS CONFIRMED A PERSISTENT TYPE I ENDOLEAK. THERE WAS NO ANEURYSM ENLARGEMENT AND NO REINTERVENTION REPORTED. REPORTEDLY, THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD ONLY ONE TREATMENT FOR A TYPE I ENDOLEAK IN 2016. REPORTEDLY, THE FOLLOW-UP ON (B)(6) 2020, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 215MM. REPORTEDLY, THERE WAS NO TYPE I ENDOLEAK NOTICED. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD A COMBINATION OF A TYPE II OR TYPE III ENDOLEAK. REPORTEDLY, THE ANEURYSM ENLARGEMENT WAS NOT ATTRIBUTED TO THE TYPE I FOUND ON (B)(6) 2016. ACCORDING TO THE PHYSICIAN THE ANEURYSM ENLARGEMENT WAS LIKELY DUE TO THE TYPE II ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 14346830 ↗
• InjuryFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY AT AN UNKNOWN ANATOMICAL LOCATION AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESES (PLA360400/17845806). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY AT AN UNKNOWN ANATOMICAL LOCATION AND UNDERWENT AN UNSPECIFIED ADDITIONAL PROCEDURE UTILIZING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES (PLA360400/21783487/22062911). ON (B)(6) 2022, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (CXT). FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502470 ↗
• InjuryDec 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON DECEMBER 29, 2021, IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER PHYSICIAN AND IS NO LONGER BEING FOLLOWED.

  Patient problems: Aneurysm

  MAUDE report 13056762 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A HUGE PSEUDOANEURYSM AT THE PROXIMAL ANASTOMOSIS OF AN OLD AORTO-BI-ILIAC GRAFT WITH EROSION OF THE ANTERIOR SPINE WITH TWO DIFFERENT VERTEBRAE. THREE GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH BACK PAIN. COMPUTED TOMOGRAPHY SCANS DATED ON (B)(6) 2021, REVEALED THE GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES APPEAR TO BE CREATING PRESSURE ON THE PATIENT¿S ANTERIOR LUMBAR SPINE AND CAUSING EROSION INTO THE ANTERIOR ASPECT OF IT (CODED 5000-C: OTHER ¿ EXPLAINED IN FILE). AN ADDITIONAL CT SCAN TAKEN ON (B)(6) 2021 IS INCLUDED IN THE IMAGING EVALUATION THAT WAS CONDUCTED. THIS EVALUATION DEMONSTRATED THE EXISTENCE OF A TYPE 1B ENDOLEAK. FURTHER INFORMATION REGARDING REINTERVENTION WAS NOT PROVIDED.

  Patient problems: Erosion; Pain

  MAUDE report 12323846 ↗
• InjuryAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INFRARENAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. ON (B)(6) 2021, FOLLOW-UP ANGIOGRAM IDENTIFIED A POSSIBLE PROXIMAL TYPE I OR TYPE II ENDOLEAK. THE PATIENT UNDERWENT RETINTERVENTION AND TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENTS WERE IMPLANTED AND RESOLVED THE ENDOLEAK. DURING THE PROCEDURE A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, REPORTED TO CAUSED BY DISEASE PROGRESSION SEEN BOTH PROXIMALLY AND DISTALLY. THE PATIENT TOLERATED THE PROCEDURE AND IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 12303617 ↗
• InjuryMar 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A PREVIOUS TREATMENT FOR A TYPE I ENDOLEAK (MANUFACTURER UNKNOWN). THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. REPORTEDLY, PRE-TREATMENT ULTRASOUND SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 134MM. ON (B)(6) 2016, A PERSISTENT TYPE I ENDOLEAK WAS IDENTIFIED. NO TREATMENT HAS BEEN REPORTED TO GORE. REPORTEDLY, FROM (B)(6) 2016, THE ANEURYSM DECREASED IN SIZE FROM 157MM TO 154.7MM. ON (B)(6) 2019, IT WAS CONFIRMED A PERSISTENT TYPE I ENDOLEAK. THERE WAS NO ANEURYSM ENLARGEMENT AND NO REINTERVENTION REPORTED. (THIS INFORMATION WAS ALREADY REPORTED TO FDA). REPORTEDLY, DR. (B)(6) CONFIRMED THAT THE PATIENT HAD ONLY ONE TREATMENT FOR A TYPE I ENDOLEAK IN 2016. AS THE OP-NOTES ARE NOT AVAILABLE, AND THE INFORMATION PROVIDED INFORMED THAT A PERSISTENT TYPE I ENDOLEAK IDENTIFIED ON(B)(6) 2016, WAS MONITORED BY THE PHYSICIAN- THE ONLY KNOWN TYPE I ENDOLEAK TREATMENT WAS PERFORMED DURING THE INITIAL PROCEDURE ON (B)(6) 2016. REPORTEDLY, THE FOLLOW-UP ON (B)(6) 2020, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 215MM. REPORTEDLY, THERE

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

  MAUDE report 11546482 ↗
• InjuryAug 6, 2020Malposition of Device; Malposition of Device

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, FOLLOW UP CT REVEALED A DISSECTION PROXIMAL TO THE CELIAC ARTERY AND A TYPE 3 DISCONNECT ENDOLEAK AND TYPE 1B ENDOLEAK ON THE RIGHT SIDE. IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE ON (B)(6) 2019, THERE WAS DIFFICULTY SNARING THE GUIDEWIRE, WHICH MIGHT HAVE LED TO WIRE TRAUMA IN THE AORTA, CAUSING OR CONTRIBUTING TO A DISSECTION. THIS WAS REPORTED TO FDA ON MFR REPORT # 3007284313-2019-00143. ON (B)(6) 2020, THE PHYSICIAN TREATED THE DISSECTION WITH A 36MM AORTIC EXTENDER COMPONENT THAT COVERED THE FENESTRATION. HOWEVER, DURING DEPLOYMENT OF THE AORTIC EXTENDER, THE DEVICE WAS INADVERTENTLY DEPLOYED OVER THE SOFT PORTION OF THE GUIDEWIRE, WHICH CAUSED THE DELIVERY CATHETER TO ROTATE AND MOVE DISTALLY DURING DEPLOYMENT, AND THE CELIAC ARTERY WAS PARTIALLY COVERED. THE PHYSICIAN THEN CANNULATED THE CELIAC ARTERY AND DEPLOYED AN 8X20 MM GORE® VIABAHN® VBX DEVICE AND EXTENDED PROXIMALLY IN THE AORTA WITH ANOTHER 36 MM AORTIC EXTENDER COMPONENT. THE TYPE 3 ENDOLEAK BETWEEN THE CEB ENDOPROSTHESIS AND THE PLC231400 IN THE RIGHT

  Patient problems: Occlusion

  MAUDE report 10373802 ↗
• InjuryJun 26, 2020Improper 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. TWO GORE® AORTIC EXTENDER COMPONENTS WERE PLACED PROXIMALLY AND COVERAGE WAS EXTENDED DISTALLY ON EITHER SIDE WITH TWO CONTRALATERAL LEG COMPONENTS. A PLA36060 DEVICE WAS REPORTED TO BE THE MOST PROXIMAL DEVICE; NO TRUNK IPSILATERAL LEG COMPONENT WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION FOR A POSSIBLE TYPE I OR TYPE III ENDOLEAK. THE TYPE OF ENDOLEAK WAS UNABLE TO BE DETERMINED INTRAPROCEDURE. AN ADDITIONAL AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMALLY, BUT DID NOT RESOLVE THE ENDOLEAK. ANOTHER AORTIC EXTENDER COMPONENT WAS THEN PLACED JUST ABOVE THE AORTIC BIFURCATION, HOWEVER THE ENDOLEAK STILL PERSISTED. THE PHYSICIAN THEN CHOSE TO RELINE THE ENTIRE SYSTEM ORIGINALLY IMPLANTED. A TRUNK IPSILATERAL LEG COMPONENT WAS PLACED PROXIMALLY, AND EXTENDED WITH ANOTHER CONTRALATERAL LEG COMPONENT. THIS SUCCESSFULLY RESOLVED THE ENDOLEAK. THERE WAS NO REPORTED MIGRATION OR ANEURYSM ENLARGEMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10203977 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2019, A FOLLOWUP IMAGING STUDY WAS PERFORMED. A POSSIBLE TYPE IA ENDOLEAK WAS NOTED AT THAT TIME. THE PHYSICIAN WILL FOLLOW UP WITH ANOTHER IMAGING STUDY IN THE FUTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889964 ↗
• InjuryJul 17, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2019, THE PATIENT PRESENTED WITH A PREVIOUSLY PLACED ANEURX STENT GRAFT THAT WAS USED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE TOP OF THE ANEURX GRAFT WAS NOW POSITIONED OVER 4 CM BELOW THE LOWEST RENAL ARTERY (RIGHT RENAL). THE PHYSICIAN DECIDED TO PLACE THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER PLACEMENT OF ALL THREE 36MM CUFFS, THE PHYSICIAN BALLOONED THE CUFFS IN PLACE TO SOLIDIFY PLACEMENT AND TO BALLOON THE APPROPRIATE JUNCTIONS. DURING THE FINAL ANGIO RUN TO CHECK FOR ENDOLEAKS, THE LOWEST RENAL APPEARED TO HAVE SOME GRAFT INFRINGING UPON IT. THE PHYSICIAN ISOLATED THE RIGHT RENAL USING A CATHETER AND DECIDED TO PLACE A 6MM X 16MM ICAST STENT GRAFT IN ORDER TO ENSURE PATENCY. THE ICAST STENT WAS DEPLOYED SUCCESSFULLY AND THE ENDOLEAK WAS RESOLVED. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799587 ↗
• MalfunctionMay 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. DURING THE PROCEDURE AFTER SUCCESSFUL DEPLOYMENT OF A GORE® AORTIC EXTENDER COMPONENT, INTRAOPERATIVE IMAGING DETERMINED THE LEADING OLIVE OF THE DELIVERY CATHETER HAD BECOME DETACHED FROM THE DELIVERY CATHETER AND WAS VISUALIZED WITHIN THE PATIENT'S VASCULATURE. THE DETACHED OLIVE AND A PORTION OF THE GUIDEWIRE WERE RETRIEVED AND THE PROCEDURE WAS CONCLUDED WITH NO ADVERSE CONSEQUENCES. THERE WERE NO REPORTED ADVANCEMENT OR DELIVERY DIFFICULTIES DURING THE PROCEDURE, HOWEVER THE PATIENT WAS REPORTED TO HAVE A VERY ANGLED PROXIMAL NECK; DEGREE OF ANGULATION UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8606118 ↗
• MalfunctionApr 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, A GORE® EXCLUDER® AAA ENDOPROSTHESIS "GOT STUCK" ON A LUNDERQUIST WIRE DURING ADVANCEMENT INTO PATIENT. IT WAS REPORTED THE DEVICE NEVER MADE IT INTO THE PATIENT. UPON REMOVAL THE WIRE WAS REMOVED WITH THE DEVICE ATTACHED TO IT. IT WAS REPLACED WITH AN IDENTICAL GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH NO ISSUE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485161 ↗
• InjuryNov 29, 2018Disconnection; Patient-Device Incompatibility; Disconnection; Patient-Device Incompatibility

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH TWO EXCLUDER® AORTIC EXTENDER COMPONENTS. ON AN UNKNOWN DATE, FOLLOW-UP EXAMINATION REPORTEDLY REVEALED A TYPE III ENDOLEAK (COMPONENT DISCONNECTION) BETWEEN TWO OF THE AORTIC EXTENDER COMPONENTS. THE PHYSICIAN ATTRIBUTED THE ENDOLEAK TO TORTUOUS AORTIC ANATOMY. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY TWO 40MM X 10CM GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED TO TREAT THE TYPE III ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115598 ↗
• InjuryJun 28, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT THE INFRARENAL AORTIC NECK WAS SHORT (8MM). INTRAOPERATIVELY IT WAS DECIDED TO ADD AN AORTIC EXTENDER ENDOPROSTHESIS (PLA). AT THE END OF THE PROCEDURE IT WAS REALIZED THAT THE PLA IS PARTIALLY COVERING THE LEFT RENAL ARTERY TO A MINIMAL EXTEND. ON (B)(6) 2018, A POST-IMPLANTATION COMPUTER TOMOGRAPHY (CT) SHOWED THAT THE LEFT RENAL ARTERY WAS FULLY OCCLUDED. FURTHER PATIENT TREATMENT IS UNKNOWN.

  Patient problems: Occlusion

  MAUDE report 7644722 ↗
• DeathJun 26, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC ANEURYSM OF THE DESCENDING AORTA MEASURING 48 MM IN DIAMETER. THE PATIENT WAS THEREFORE TREATED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2015, A TYPE 1A ENDOLEAK WAS DIAGNOSED AND A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT PLA360400 WAS IMPLANTED IN AN ATTEMPT TO SOLVE THE ENDOLEAK SITUATION. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING (CTA) REVEALED AN ANEURYSM DIAMETER OF 98 MM. WITH AN ONSET DATE OF (B)(6) 2015, THE TYPE 1A ENDOLEAK WAS REPORTED TO PERSIST. ON THE SAME DAY, A FENESTRATED PROSTHESIS WAS IMPLANTED TO REPAIR THE ENDOLEAK. ON (B)(6) 2015, ADDITIONAL FOLLOW-UP CTA IMAGING WAS PERFORMED AND IDENTIFIED AN ANEURYSM DIAMETER OF 100 MM. ON (B)(6) 2015, FOLLOW-UP IMAGING DIAGNOSED A RUPTURED ANEURYSM AND ON (B)(6) 2015, ADDITIONAL CTA IMAGING REVEALED AN ONGOING ANEURYSM ENLARGEMENT WITH A DIAMETER OF 105 MM. ON (B)(6) 2015, THE PATIENT WAS REPORTED TO HAVE EXPIRED FOLLOWING THE AORTIC RUPTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Sudden Cardiac Death

  MAUDE report 7638427 ↗

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