GORE EXCLUDER AAA Endoprosthesis PLA280300Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132618781), received between Sep 11, 2018 and May 14, 2026 — classified as 3 deaths, 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Malposition of Device

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM DEVICES. A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER WAS PLACED TO EXTEND THE TRUNK COMPONENT; HOWEVER, DURING BALLOONING, THE EXTENDER MIGRATED DISTALLY (DISTANCE UNKNOWN), RESULTING IN A PROXIMAL TYPE I ENDOLEAK. AN ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS THEN IMPLANTED PROXIMALLY, WHICH RESOLVED THE ENDOLEAK. IT WAS NOTED THAT THE SECOND AORTIC EXTENDER PARTIALLY COVERED THE RENAL ARTERY, BUT BLOOD FLOW REMAINED UNOBSTRUCTED. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN PLACE AND CONCLUDED THE PROCEDURE. THE PATIENT INITIALLY TOLERATED THE PROCEDURE; HOWEVER, HER BLOOD PRESSURE SUBSEQUENTLY DECREASED DUE TO INADEQUATE GROIN CLOSURE. SHE WAS RETURNED TO THE OPERATING ROOM FOR ADDITIONAL CLOSURE. AT THE TIME OF THE REPORT, THE PATIENT REMAINED IN THE OPERATING ROOM WHILE THE TEAM WORKED TO ACHIEVE ADEQUATE GROIN CLOSURE. THIS GROIN COMPLICATION WAS NOT RELATED TO THE GORE DEVICES BUT WAS PROCEDURAL IN NATURE. ON MAY 12, 2026, THE PHYSICIAN REPORTED THAT THE PATIENT WAS

  Patient problems: Aneurysm

  MAUDE report 25176341 ↗
• DeathNov 16, 2023Partial Blockage; Obstruction of Flow; Unintended Movement; Partial Blockage; Obstruction of Flow; Unintended Movement

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXC141400 AND PXT261418). PATIENT HAS HAD ANNUAL ABDOMINAL U/S SURVEILLANCE WHICH HAVE SHOWN NO DEFINITIVE LEAKS, HOWEVER, THE AAA HAS SHOWN A GRADUAL INCREASE IN SIZE OVER THE LAST 10 YEARS. THIS YEAR, THE SURVEILLANCE REVEALED A 5.4CM AAA WHICH IS A 4MM INCREASE IN SIZE FROM LAST YEAR'S SCAN. A CTA WAS ORDERED (DATE UNKNOWN) WHICH REVEALED THE AAA WAS CLOSER TO 5.7CM. AGAIN, THERE WAS NO DEFINITIVE LEAKS SEEN BUT IN REVIEW WITH A FIELD SALES ASSOCIATES (FSA) THERE MAY BE A WISP OF CONTRAST COMING FROM THE TOP OF THE GRAFT ON THE RIGHT SIDE AND THE RIGHT LIMB IS BARELY SEATED IN THE ILIAC ARTERY. PATIENT DENIES ABDOMINAL PAIN. ON OCTOBER 20, 2023, FSA WAS NOTIFIED THAT PHYSICIAN PLANS TO INTERVENE AS THERE MAY BE A POSSIBLE TYPE 1A ENDOLEAK THAT THEY SUSPECTED DUE TO EXPANDING ANEURYSM BUT UNKNOWN IF ITS COMING FROM THE TRUNK IPSILATERAL OR CONTRALATERAL LEG. ON (B)(6) 2023, THE PATIENT WAS BROUGHT IN FOR A REINTERVENTION PROCEDURE BY EXTENDING PROXIMALLY FROM THE BIFURCATED STENT GRAFTS (TRUNK IPSILATERAL

  Patient problems: High Blood Pressure/ Hypertension; Obstruction/Occlusion

  MAUDE report 18154925 ↗
• InjuryNov 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON AN UNKNOWN DATE, THE PATIENT WAS TREATED FOR AN UNKNOWN ISSUE. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A TYPE IA AND TYPE II ENDOLEAK. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. THE TYPE IA ENDOLEAK WAS REPAIRED, BUT THE TYPE II REMAINS. THE PHYSICIAN WILL MONITOR IT BEFORE DECIDING WHETHER ADDITIONAL ACTIONS WILL BE TAKEN.

  Patient problems: Clinical Endoleak

  MAUDE report 18145144 ↗
• InjuryNov 2, 2023Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Migration; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Migration

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PRESUMED PROXIMAL TYPE I ENDOLEAK USING A GORE® EXCLUDER®AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT (REPORTED SEPARATELY, MPDCASE- 00016291-1). REPORTEDLY, ACCORDING TO THE SURGEON, WHILE DEPLOYING THE AORTIC EXTENDER COMPONENT, THE CUFF ¿JUMPED UP¿ APPROXIMATELY 5MM AND COVERED A RENAL ARTERY. THE SURGEON WAS UNABLE TO SALVAGE THE COVERED RENAL AND PROCEDURE WAS FINISHED. ACCORDING TO THE PHYSICIAN, THE MAIN BODY HAD A ¿BIRD BEAK¿ ON ONE SIDE THAT MAY HAVE BEEN CAUSING THE ENDOLEAK. ADDITIONALLY, THE AORTIC NECK OF THE INFRARENAL AORTA WAS ANGLED. THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN THOUGHT MAYBE THE ANGLE OF THE ANATOMY CAUSED THE CUFF TO SHIFT WHILE BEING DEPLOYED. THE ANGIOGRAPHY RUNS IT APPEARED THERE WAS STILL SOME FLOW IN THE RENAL ARTERY. THE PHYSICIAN STATED THE PATIENT HAS SOME FLOW IN THE RENAL ARTERY AND HAS AN ACCESSORY RENAL THAT ALSO HAS FLOW. FORTUNATELY, THE PATIENT'S LAB WORK INDICATED THERE HAS BEEN LITTLE TO NO IMPACT ON HIS KIDNEY FUNCTION.

  Patient problems: Clinical Endoleak; Reduced Blood Flow

  MAUDE report 18061341 ↗
• InjuryFeb 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 64.8MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. ADDITIONALLY, THE LEFT RENAL ARTERY WAS EMBOLIZED AND STENTED AT THIS TIME THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 65MM. ON (B)(6) 2022, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED A TYPE II ENDOLEAK OF THE AORTIC GRAFT; THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 109MM. ON (B)(6) 2022, FOLLOW-UP COMPUTED TOMOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 106MM. ON (B)(6) 2022, THE PATIENT UNDERWENT ANGIOGRAPHY AND AN AORTOGRAM OF THE SUPERIOR AND INFERIOR MESENTERIC ARTERIES, RIGHT INTERNAL ILIAC ARTERIES. THE PATIENT THEN UNDERWENT REINTERVENTION FOR A TYPE II ENDOLEAK AND THE LEFT LUMBAR ARTERY WAS COIL EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR A TYPE II ENDOLEAK AND COIL AND THROMBIN EMBOLIZATION O

  Patient problems: Aneurysm

  MAUDE report 16414902 ↗
• InjuryDec 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER®AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN OCTOBER 2022, THE PATIENT REPORTED PAIN, AND THE PHYSICIAN SUSPECTED A TYPE II ENDOLEAK. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 15920425 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A STAGED REINTERVENTION FOR TREATMENT OF A THORACOABDOMINAL AORTIC DISSECTION AND COMPLETION OF TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM RCIA. FEMORAL CUTDOWNS WERE PERFORMED RATHER THAN PERCUTANEOUS ACCESS FOR THIS REPAIR. USING A CURVED CATHETER WE ATTEMPTED TO ENTER THE TRUE LUMEN ON THE LEFT SIDE AND WERE IN THE TRUE LUMEN IN THE AREA OF THE LEFT COMMON ILIAC GRAFT. A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT WAS DEPLOYED JUST DISTAL TO THE LOWEST RENAL ARTERY AND DEPLOYED DOWN TO THE OPEN THE GATE. THE REST OF THE MAIN BODY REMAINED UNDEPLOYED. A GORE® CONTRALATERAL LEG COMPONENT WAS THEN ADVANCED AND EXTENDED DOWN INTO THE PREVIOUSLY REPAIRED LEFT COMMON ILIAC ARTERY AND BALLOONED. ON THE RIGHT SIDE WE THE REST OF THE MAIN BODY WAS FULLY DEPLOYED AND AN EXTENSION LIMB WAS PLACED INTO THE EXTERNAL ILIAC ARTERY PAST THE AREA OF THE EMBOLIZED HYPOGASTRIC VESSEL. THE PROXIMAL END OF THE MAIN TRUNK WAS NOT BALLOONED DUE TO THE DISSECTION, HOWEVER THE REST OF THE GRAFT INCLUDING AT THE BIFURCATION WAS BALLOONED ON BOTH SIDES. EXCELLENT FLOW WAS SEEN INTO THE EXTERNAL ILIAC ARTERY ON THE RIGHT AND TO BOTH THE INTERNAL AND EXTERNAL ILIAC

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 13691242 ↗
• DeathSep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER COFFEE-GROUND VOMITUS AND ABDOMINAL PAIN. WORK UP REVEALED INCREASED SIZE IN THE INFRARENAL AORTIC ANEURYSM ALONG WITH AN ENDOLEAK OF UNDISCLOSED TYPE. THE RECOMMENDATION WAS FOR CONSERVATIVE MANAGEMENT BY THE VASCULAR TEAM. ON (B)(6) 2020, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED TO GORE.

  Patient problems: Aneurysm

  MAUDE report 12463226 ↗
• InjuryApr 21, 2021Positioning Problem; Positioning Problem

  ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED AND IN PLACE. WHILE THE PHYSICIAN ATTEMPTED TO CANNULATE THE CONTRALATERAL GATE, THE DEVICE MIGRATED DISTALLY APPROXIMATELY 5MM WHICH CAUSED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN CHOSE TO IMPLANT AN AORTIC EXTENDER ENDOPROSTHESIS TO TREAT THE MIGRATION AND ENDOLEAK. WHILE THE DEVICE WAS BEING DEPLOYED, IT APPEARED NOT TO FULLY EXPAND (FLOWER OUT). THE DEVICE WAS BALLOONED AND EXPANDED. IN ADDITION, THE DEVICE MOVED PROXIMALLY DURING DEPLOYMENT AND COVERED THE RIGHT RENAL ARTERY. REGARDLESS OF MULTIPLE ATTEMPTS TO PULL DOWN THE DEVICE, IT COULD NOT BE ADJUSTED DURING THE PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE COVERED RIGHT RENAL ARTERY WAS LEFT COVERED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11701612 ↗
• InjuryFeb 14, 2020Use of Device Problem; Use of Device Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, DURING THE PROCEDURE, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM MIGRATED DISTALLY A LITTLE (DISTANCE UNKNOWN) AND THE PHYSICIAN DECIDED TO IMPLANT THE AORTIC CUFF. UPON DEPLOYMENT, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT JUMPED FORWARD AND COVERED BOTH RENAL ARTERIES. THE PHYSICIAN MANAGED TO GET AN OSCAR SHEATH INTO BOTH RENAL ARTERIES FAST AND PULLED DOWN THE EXTENDER FABRIC, AND PLACED ATRIUM STENTS IN THE RENAL ARTERIES. AN EXCELLENT FINAL RESULT WAS ACHIEVED. REPORTEDLY, THERE WAS NOTHING IN PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. AS REPORTED BY THE PHYSICIAN THE DEPLOYMENT INACCURACY MAY CAUSE MIGRATION. THE PATIENT TOLERATED THE PROCEDURE AND ON (B)(6) 2020 WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Occlusion

  MAUDE report 9714811 ↗
• DeathJan 22, 2020Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ENLARGING 5.5CM ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT POST DEPLOYMENT OF THE DEVICES A PROXIMAL TYPE I ENDOLEAK WAS SEEN AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY. DURING ANGIOPLASTY OF THE AORTIC EXTENDER COMPONENT USING A GORE® MOLDING & OCCLUSION BALLOON (MOB), INCREASED EXTRAVASATION WAS SEEN AND ANGIOGRAPHY DETERMINED A RUPTURE AT THE ORIGIN OF THE LEFT RENAL ARTERY DUE TO SUSPECTED OVER INFLATION OF THE BALLOON. REPORTEDLY DUE TO THE PATIENT'S SHORT ANGULATED NECK COUPLED WITH CALCIFICATION IN THE AORTIC NECK; GOOD SEAL WAS UNABLE TO BE ACHIEVED. THE PHYSICIAN CONVERTED TO OPEN REPAIR WHEREIN GRAFTS WERE SEWN IN TO RELINE THE DEVICES. MASSIVE TRANSFUSION PROTOCOL WAS INITIATED FOR THE PATIENT WHO WAS TRANSFUSED WITH 11 LITRES. THE PROCEDURE WAS CONCLUDED WITH AN "OPEN" CLOSE FOR THE PATIENT, WITH A PLAN WAS TO REINTERVENE THE NEXT DAY AND PERFORM AN AX FEMORAL BYPASS. ON (B)(6) 2020, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 9618820 ↗
• MalfunctionNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS INTENDED FOR USED IN A PROCEDURE, HOWEVER THE DEVICE WOULD NOT DEPLOY. ON JANUARY 8, 2020 IT WAS LEARNED THAT THE DEVICE WAS NEVER ATTEMPTED TO BE DEPLOYED. THE ISSUE WAS THAT THE DEVICE COULD NOT BE LOADED ONTO THE GUIDEWIRE. THE DEVICE DID NOT ENTER THE PATIENT'S BODY AT ALL. THE EVENT IS NO LONGER CONSIDERED A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329765 ↗
• InjuryAug 9, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT, UPON PLACEMENT OF THE PLA280300 AORTIC EXTENDER COMPONENT FOR PROXIMAL EXTENSION, THE DEVICE DEPLOYED AT AN ANGLE. REPORTEDLY THE ANGLE PLACED THE DEVICE HIGHER ON THE LEFT, SUBSEQUENTLY CAUSING PARTIAL COVERAGE OF THE PATIENT'S LOWEST RENAL ARTERY (LEFT RENAL). THE PHYSICIAN ATTEMPTED TO PULL THE AORTIC EXTENDER COMPONENT DOWN USING AN AORTIC BALLOON (Q50). THE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN PLACED A 5MMX17MM STENT (TYPE UNKNOWN) IN THE PATIENT'S LEFT RENAL ARTERY. AFTER PLACEMENT OF THE STENT THE PHYSICIAN REPORTED THAT THE BLOOD FLOW TO THE PATIENT'S LEFT RENAL ARTERY HAD BEEN COMPLETELY RESTORED AND NORMALIZED. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8880200 ↗
• MalfunctionJan 30, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT TO TREAT A PROXIMAL TYPE I ENDOLEAK FROM A PREVIOUSLY IMPLANTED NON-GORE MANUFACTURED STENT GRAFT. ACCORDING TO THE REPORT, NO RESISTANCE OR OTHER NOTABLE ISSUES DURING CATHETER ADVANCEMENT WERE REPORTED. WHEN THE DEPLOYMENT KNOB WAS PULLED, THE DEPLOYMENT LINE WAS REPORTEDLY BROKEN. THE PHYSICIAN WAS REPORTEDLY ABLE TO SUCCESSFULLY COMPLETE THE DEPLOYMENT, AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289818 ↗
• InjuryDec 17, 2018Malposition of Device; Malposition of Device

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A SYSTEM OF GORE® EXCLUDER® AAA ENDOPROSTHESES AS PART OF AN ENDOVASCULAR AORTIC REPAIR. AFTER THE ENDOPROSTHESES HAD BEEN IMPLANTED, A FINAL PROCEDURAL ANGIOGRAPH REPORTEDLY REVEALED A SLIGHT TYPE I ENDOLEAK AT THE PROXIMAL END OF A 26MM TRUNK-IPSILATERAL LEG COMPONENT. A 28.5MM X 3.3CM AORTIC EXTENDER COMPONENT (PLA280300/(B)(4)) WAS THEN IMPLANTED PROXIMALLY TO TREAT THE ENDOLEAK. ACCORDING TO THE REPORT, THE INFRARENAL AORTIC NECK WAS ANGULATED (MEASUREMENT UNKNOWN), AND THE AORTIC EXTENDER COMPONENT HAD PARTIALLY AND UNINTENTIONALLY COVERED THE LEFT RENAL ARTERY. THE PHYSICIAN PLACED A RENAL STENT TO PRESERVE BLOOD FLOW TO THE LEFT RENAL ARTERY, AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY FURTHER REPORTED COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8169820 ↗
• InjuryNov 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2015, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND COMMON ILIAC ARTERY ANEURYSM WITH SEVERAL GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 43.5MM. REPORTEDLY THE MAXIMUM AORTIC NECK DIAMETER IN THE LANDING ZONE WAS 24.5 MM. AT THE END OF THE PROCEDURE A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED BUT LEFT UNTREATED. ON (B)(6) 2016, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHEREBY TWO ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDERS WERE IMPLANTED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. A FINAL ANGIOGRAM SHOWED RESOLUTION OF THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 43.5MM (THIS INFORMATION WAS COVERED BY THE EVENT# (B)(4), MEDWATCH# 3007284313-2016-00199, REPORTED ON OCTOBER 12, 2016). ON (B)(6) 2016, FOLLOW-UP CTA DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 44MM. IT WAS REPORTED THAT ON (B)(6) 2017, A TYPE III ENDOLEAK WAS IDENTIFIED DUE TO THE DISCONNECTION

  Patient problems: Aneurysm

  MAUDE report 8075424 ↗
• InjurySep 11, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT281418/(B)(4), PXL161407/(B)(4), PLA280300/(B)(4), PXC141400/(B)(4), AND PXC141200/(B)(4)) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK WITH ANEURYSMAL ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2018, THE PATIENT UNDERWENT COIL-EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT THE TYPE II ENDOLEAK. HOWEVER, THE ENDOLEAK REPORTEDLY REMAINED AFTER THE PROCEDURE. ON (B)(6) 2015, A TYPE II ENDOLEAK ORIGINATING FROM THE IMA AND LUMBAR ARTERIES WAS CONFIRMED BY COMPUTED TOMOGRAPHIC ANGIOGRAPHY. ON THIS DATE, THE PATIENT UNDERWENT AN OPEN PROCEDURE WHEREBY THE STENT GRAFT COMPONENTS WERE EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND, THEREFORE, WERE NOT AVAILABLE FOR ANALYSIS BY GORE.

  Patient problems: No Code Available

  MAUDE report 7865467 ↗

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-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)