GORE EXCLUDER AAA Endoprosthesis PLC201000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00733132618590), received between Oct 31, 2018 and Nov 25, 2025 — classified as 3 deaths, 34 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A CHRONIC DISSECTION. THE DISSECTION HAD BEEN PRESENT FOR 20 YEARS, BUT MORE RECENTLY THE FALSE LUMEN HAD BEGUN GROWING, SHRINKING THE SPACE IN THE TRUE LUMEN. THE PROCEDURE USED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK (CXT) DEVICE, A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE AND TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) DEVICES; ONE IN THE DESCENDING THORACIC AORTA, AND ONE PHYSICIAN MODIFIED GRAFT (PMG) WITH FENESTRATIONS IN THE THORACOABDOMINAL AORTA. DEVICES WERE INTRODUCED THROUGH THE RIGHT-SIDE USING A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). THE PROCEDURE BEGAN WITH A SEPTOTOMY, FROM THE PRIMARY ENTRY TEAR (PET) IN THE PROXIMAL DESCENDING THORACIC AORTA, ALL THE WAY TO THE RIGHT COMMON ILIAC. NEXT THE CXT WAS PLACED INFRARENALLY, WITH A 20MM FLARED CONTRALATERAL LEG DEVICE PLACED IN THE RIGHT ILIAC, JUST PROXIMAL TO THE INTERNAL/EXTERNAL BIFURCATION. THE PMG WAS PLACED NEXT, WITH THE DISTAL END LANDING IN THE CXT DEVICE. 3 ICAST STENTS WERE PLACED INTO THE FENESTRATIONS INTO THE LEFT RENAL ARTERY, SMA, AND CELIAC ARTER

  Patient problems: Perforation of Vessels

  MAUDE report 23649275 ↗
• InjuryNov 23, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES. THE GORE® DEVICES WERE SUCCESSFULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED HOME ON (B)(6) 2025. PRE- TREATMENT CTA ON (B)(6) 2025 SHOWED THAT THE MAXIMUM DIAMETER OF A RIGHT COMMON ILIAC ARTERY WAS 55MM. MINIMUM DIAMETER OF A RIGHT COMMON ILIAC ARTERY WAS 23 MM. ON (B)(6) 2025, GORE FOLLOW UP IMAGING REVEALED A TYPE II ENDOLEAK FROM LUMBAR ARTERIES. ADDITIONALLY, AN ENDOLEAK INDETERMINATE TYPE WAS NOTED. ON (B)(6), 2025, GORE FOLLOW UP IMAGING REVEALED A TYPE II ENDOLEAK FROM LUMBAR ARTERIES. NO OTHER ADVERSE EVENTS HAVE BEEN NOTICED. THE SITE CONFIRMED GORE IMAGING FINDINGS AND DR. (B)(6) STATED THAT THEY ARE PREPARING TO FIX THE ENDOLEAKS (TYPE II AND INDETERMINATE) MOST LIKELY IN DECEMBER. ADDITIONALLY, ACCORDING TO THE SITE, THE ANEURYSM ENLARGED FROM (B)(6) 2025 FROM 52MM TO 56MM. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23627915 ↗
• MalfunctionOct 28, 2025Break; Activation Failure; Break; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG). REPORTEDLY, AFTER THE CONTRALATERAL LEG WAS INSERTED, THE DEPLOYMENT STRING BROKE AT THE DISTAL AREA OF THE GRAFT, THUS, THE DEVICE DID NOT DEPLOY AT ALL. THE CONTRALATERAL LEG WAS REMOVED, DISCARDED, AND REPLACED WITH ANOTHER CONTRALATERAL LEG. THE CAUSE OF THE DEPLOYMENT STRING BREAKAGE IS UNKNOWN AND THE ANATOMY WAS A LITTLE TORTUOUS BUT NOT BAD. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402831 ↗
• InjuryApr 18, 2025Adverse 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) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND AN ILIAC AORTIC ANEURYSM TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ILIAC BRANCH COMPONENT, AFTER ADVANCING THE IBE DEVICE THE PHYSICIAN DECIDED THAT TRYING TO ADVANCE THE SHEATH UP AND OVER THE BIFURCATION WOULD BE TOO DIFFICULT GIVEN PATIENT ANATOMY AND DECIDED TO ABANDON THE PROCEDURE. THE PATIENT HAD EXTREME ILIAC ARTERY TORTUOSITY. THE PHYSICIAN CHOSE TO ABANDON THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES PORTION AND COILED THE HYPOGASTRIC ARTERY AND EXTENDED THAT LIMB WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE CASE PROCEEDED UNEVENTFULLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 21869568 ↗
• InjuryMar 5, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A INFRARENAL ABDOMINAL AORTIC ANEURYSM MEASURING 55 MM IN DIAMETER; AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ADDITIONALLY, THIS DATE A "MISPLACED LEFT ENDOGRAFT LIMB" WAS REPORTED AND REQUIRED OTHER SURGICAL TREATMENT. A LEFT FLANK INCISION TO REMOVE THE MISPLACED ENDOGRAFT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 53 MM. ON (B)(6) 2021, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 42 MM. ON (B)(6) 2021, IT WAS REPORTED THE PATIENT EXPIRED FROM CARDIOVASCULAR DISEASE WHICH WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE PHYSICIAN REPORTS PER THE DEATH CERTIFICATE ONSET DATE OF THE CARDIOVASCULAR DISEASE WAS 20 YEARS AGO, HOWEVER THERE WAS NO HISTORY OF THIS IN THE PATIENT¿S MEDICAL RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528715 ↗
• InjuryOct 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED. ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) WAS OBSERVED AND THE PHYSICIAN REPORTEDLY SUSPECTED A DISTAL ENDOLEAK ON THE DEVICE LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. IT WAS REPORTEDLY UNKNOWN IF THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT OR A CONTRALATERAL LEG COMPONENT WAS LOCATED IN THE PATIENT'S RIGHT ILIAC ARTERY. THE RIGHT LIMB WAS EXTENDED USING AN ADDITIONAL CONTRALATERAL LEG COMPONENT. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE. (PREVIOUSLY CAPTURED ON MPDCASE-(B)(4). ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN ANEURYSM WITH CONFIRMED BUT SUSPECTED TYPE 1B ENDOLEAK OR TYPE 2 ENDOLEAK ON THE RIGHT-SIDE GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG). REPORTEDLY, PHYSICIAN EXTENDED DISTALLY WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG) FROM THE GATE INTO THE RIGHT INTERNAL ILIAC ARTERY AND ALSO DID COIL EMBOLIZATION FOR THE TYPE 2 ENDOLEAK

  Patient problems: Clinical Endoleak

  MAUDE report 20363785 ↗
• 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, PXC121000/13444897, PLC201000/ (B)(6). 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 20327844 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT UNDERWENT EVAR FOR AN AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES - ONE TRUNK, AND TWO CONTRALATERAL LIMBS. ON AN UNKNOWN DATE IN 2024, THE PHYSICIAN NOTICED A TYPE 1B ENDOLEAK AND ANEURYSM ENLARGEMENT. ON JULY 31, 2024, A REINTERVENTION OCCURRED TO TREAT THE ENDOLEAK. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE PLACED INTO THE 20MM CONTRALATERAL LIMB ON THE RIGHT SIDE. ENDOANCHORS WERE ALSO IMPLANTED AS A PREVENTATIVE MEASURE. THE REINTERVENTION WAS SUCCESSFUL.

  Patient problems: Clinical Endoleak

  MAUDE report 20018309 ↗
• InjuryAug 20, 2024Migration; Migration

  THE FOLLOWING WAS REPORTING TO GORE: ON (B)(6) 2013, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2024, A PATIENT UNDERWENT A REINTERVENTION DUE TO A MIGRATION OF THOSE DEVICES LEADING TO A PROXIMAL ENDOLEAK . THE PHYSICIAN PLACED A PHYSICIAN-MODIFIED STENT GRAFT PROXIMALLY, WITH FENESTRATIONS FOR THE SMA, CELIAC, AND RENAL ARTERIES. THE REINTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED. REPORTEDLY, THE MIGRATION WAS GREATER THAN 7CM.

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005908 ↗
• InjuryJul 1, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH A RIGHT COMMON ILIAC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK. ON (B)(6) 3018, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED TO TREAT THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 19643396 ↗
• InjuryJul 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND TWO CONTRALATERAL LEGS). PRIOR TO PROCEDURE, THEY DECIDED TO UPSIZE THE MAIN BODY TRUNK IN ORDER TO GAIN MORE PROXIMAL SEAL. PROCEDURE ENDED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT WAS BROUGHT IN FOR AN EMERGENT REINTERVENTION TO DO A REVISION OF PRIOR EVAR PROCEDURE AS THE RIGHT SIDE LIMB (CONTRALATERAL LEG) HAD COMPLETELY PULLED OUT PROXIMALLY OF THE COMMON ILIAC ARTERY (MIGRATION DISTANCE 2CM OR MORE), THEREFORE, THERE WAS NO DISTAL SEAL WHICH RESULTED IN THE ANEURYSM RUPTURE. THE COMMON ILIAC ARTERY WAS 2.5CM IN LENGTH AND THE AAA WAS MASSIVE (SIZE UNKNOWN) AND BIASED TO LEFT SIDE. THE DEVICE PULLING OUT IS RELATED TO THE ANEURYSM SIZE, MORPHOLOGY, AND A SHORTER THAN AVERAGE COMMON ILIAC LENGTH. DURING THE PROCEDURE, TWO CONTRALATERAL LEGS WERE USED TO PROVIDE FOR THE DISTAL SEAL AND EXTENSION FROM THE FLOW DIVIDER OF THE MAIN BODY GRAFT. NO ENDOLEAKS WERE NOTED AND USED AN AORTIC EXTENDER CONFORMABLE (23CXA) ACROSS THE OSTIUM OF THE RI

  Patient problems: Ruptured Aneurysm

  MAUDE report 19643282 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS CXT321414 AND GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC201000. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT, AND THE PATIENT TOLERATED THE PROCEDURE. THE FSA REPORTED THAT HE RECEIVED A CD ON 6-JUN-2024 THAT INDICATED A TYPE IB ENDOLEAK FROM EITHER THE LEFT OR RIGHT ILIAC ARTERY. THE ILIACS WERE REPORTED TO BE 2-3CM, SO IT HAD BEEN A CHALLENGE TO GET A SEAL. AFTER THE PROCEDURE, THERE WAS NO SIGN OF AN ENDOLEAK, BUT A TYPE IB HAS BEEN IDENTIFIED. THE PATIENT IS SCHEDULED FOR REINTERVENTION (B)(6) 2024 TO COIL AND COVER THE INTERNAL ILIAC. THE PHYSICIAN STATES THAT THE ENDOLEAK WAS DUE TO LACK OF APPOSITION BY THE STENTS. THE FSA WAS UNABLE TO DETERMINE WHICH OF THE STENTS HAD THE ENDOLEAK. ADDITIONAL INFORMATION WAS RECEIVED AFTER THE REINTERVENTION OF (B)(6) 2024. THERE WERE ENDOLEAKS ON BOTH SIDES. THE PHYSICIAN RESOLVED THE LEAK ON THE RIGHT SIDE BY BALLOONING. THE LEFT SIDE WAS RESOLVED BY COILING THE LEFT INTERNAL ILIAC AND EXTENDING WITH A 12MM LIMB. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19639226 ↗
• DeathMay 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION REPORTED FROM USER-FACILITIES MEDWATCH REPORT #(B)(4) : ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT A COMPLEX THORACOABDOMINAL AORTIC DISSECTION WITH ANEURYSM. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR ENDOVASCULAR ARCH BRANCH REPAIR ON (B)(6) 2024, CONVERTED TO OPEN EXPLORATORY LAPAROTOMY, MTP (MASSIVE TRANSFUSION PROTOCOL) ACTIVATED. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE PHYSICIAN REPORTED THIS WAS A VERY HIGH-RISK CASE GIVEN THE LOCATION OF THE ANEURYSM WITH DISSECTION AND INVOLVEMENT OF THE BRANCH. THIS IS A KNOWN COMPLICATION THAT THE AORTIC TISSUE IS VERY THIN THESE CASES, WHICH CAN LEAD TO THE COMPLICATION THAT DID OCCUR. A CUSTOM STENT WAS USED DURING THE PROCEDURE. THIS TYPE OF DISSECTION WITH A ANEURYSM CARRIES A VERY HIGH RISK OF MORTALITY. WITHOUT SURGERY THE PATIENT WOULD HAVE EXPIRED FROM THE ANEURYSM. THE COMPLICATION WAS NOTED IMMEDIATELY, AND APPROPRIATE STEPS WERE TAKEN, BALLOON CONTROL, ADDITIONAL STENTING, OPEN CONVERSION.

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

  MAUDE report 19331943 ↗
• InjuryJan 24, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  ON JANUARY 11, 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AT THE END OF THE PROCEDURE, THE PATIENT¿S RIGHT COMMON ILIAC ARTERY WAS RUPTURED AS DOCTOR WAS BALLOONING THE PLC201000/27561267 BY THE CODA® BALLOON AT THE END OF THE PROCEDURE. A CODA® BALLOON CATHETER (COOK INCORPORATED, BLOOMINGTON, IN) WAS ALSO ADVANCED ON LEFT SIDE TO OCCLUDE AORTA WHILE ADVANCED A PLC121000 OVER THE RUPTURED ILIAC TO ACHIEVE THE SEAL IN THE EXTERNAL ARTERY AND OCCLUDING THE INTERNAL ILIAC. THE CASE WAS COMPLETED WITH PATIENT STABLE CONDITION. IT WAS REPORTED THAT THE PHYSICIAN POSSIBLY OVER INFLATED THE DEVICE. REPORTEDLY, THE MID ILIAC VESSEL WAS ON IFU AND MEASURED AT 18.5MM, THE DISTAL ILIAC WAS SMALLER AT 14MM-15MM. THE PLC201000/27561267 WAS NOT DAMAGED.

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

  MAUDE report 18577146 ↗
• InjuryDec 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE IN ZONE 9 INFRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ENLARGED RIGHT COMMON ILIAC ARTERY UTILIZING ONE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (B)(4), THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC161200, PLC201000 AND PLC161400), TWO GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB37) AND TWO GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1233 AND DSF1633). REPORTEDLY, DURING THE CASE, EVERYTHING WENT AS PLANNED WITH ALL DEVICES DEPLOYED SUCCESSFULLY WITH NO DEPLOYMENT OR POSITIONING ISSUES AS ALL DEVICES LANDED AT THE INTENDED LOCATION. NEAR THE END OF THE PROCEDURE, BALLOONING WAS BEING DONE IN THE COMMON ILIAC ARTERIES WHEN THE ANESTHESIA REP NOTIFIED THAT THEY LOST PRESSURE, THEN AN ANGIOGRAPHY WAS DONE AND IT SHOWED THAT THE RIGHT COMMON ILIAC ARTERY WAS BLEEDING OUT (EXTRAVASATION). THE PHYSICIAN THEN BRIDGED FROM THE PROXIMAL END OF THE RIGHT COMMON ILIAC COMPONENT INTO THE EXTERNAL ILIAC ARTERY WITH ANOTHER PIECE OF THE EXCLUDER GRAFT (PLC161400) AND SEALED THE EXTRAVASATION. NO BLOOD LOSS VISIBLE ON OUTSIDE OF THE PATIENT AND BLOOD LOSS VOLUME IS UNKNOWN INSI

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 18376966 ↗
• InjuryNov 28, 2023Partial Blockage; Malposition of Device; Partial Blockage; Malposition of Device

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. WHILE IMPLANTING A GORE® EXCLUDER® AAA ENDOPROSTHESIS, THE PHYSICIAN ACCIDENTALLY COVERED THE HYPOGASTRIC AND INTERNAL ILIAC ARTERIES. THE PHYSICIAN USED A BALLOON TO PUSH THE DEVICE UP, BUT BOTH VESSELS STILL WERE PARTIALLY COVERED. THERE WAS STILL GOOD BLOOD FLOW TO THE ARTERIES, SO THE PHYSICIAN ENDED THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 18222919 ↗
• InjuryNov 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PLC201000) . ON (B)(6) 2022, PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO ANEURYSM ENLARGEMENT NOTED ON PLC201000 SIDE (AMOUNT UNKNOWN), ATTRIBUTED TO DISEASE PROGRESSION. NO ENDOLEAK WAS NOTED. PHYSICIAN EXTENDED DISTALLY. A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL COMPONENT WAS IMPLANTED. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO ANEURYSM ENLARGEMENT (LESS THAN 0.5CM) ON THE RIGHT SIDE ((RLT351414), ATTRIBUTED TO DISEASE PROGRESSION. NO ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO PLACE A LIMB EXTENSION USING A CONTRALATERAL LEG TO EXTEND THE SEAL ZONE SEVERAL CENTIMETERS ALL THE WAY TO THE ORIGIN OF THE RIGHT HYPOGASTRIC ARTERY. THIS EXTENSION WAS COMPLETED USING THE FOLLOWING DEVICE: PLC201000 L/S#: (B)(4). PATIENT TOLERATED THE PROCEDURE. CODE 1003-E-NONE WAS USED TO CAPTURE ANEURYSM ENLARGEMENT WITH NO OBSERVED ENDOLEAK.

  Patient problems: Aneurysm expansion

  MAUDE report 18222239 ↗
• InjuryAug 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM HAS BEEN TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2019. REPORTEDLY, ON (B)(6) 2023 , THE ENDOPROSTHESIS WAS EXPLANTED DUE TO A TYPE II ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 17581219 ↗
• MalfunctionJun 15, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TO BE IMPLANTED WITH A 20MM X 10CM GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER® DEVICE) TO TREAT AAA. THE DEPLOYMENT KNOB OF THE DEVICE COULDN'T BE FULLY PULLED, RESULTING IN INCOMPLETE DEPLOYMENT OF THE DEVICE. PHYSICIAN REMOVED THE DEVICE THROUGH THE SHEATH. ANOTHER EXCLUDER® DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN TESTED THE DEVICE AT BACK TABLE AFTER IT IS REMOVED. THE DEVICE COMPLETED THE DEPLOYMENT SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132876 ↗
• InjuryMar 30, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ACCORDING TO THE SITE, THEY HAVE TO EXPLANT ALL GORE® EXCLUDER® AAA ENDOPROSTHESES. DR. SETTEL REVIEWED THE IMAGING- AND HE CONFIRMS EVERY GRAFT EVER IMPLANTED WAS EXPLANTED.

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 16641172 ↗
• InjuryMar 20, 2023Malposition of Device; Malposition of Device

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION PROCEDURE. ONE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES WAS FOUND TO BE ENCROACHING ON THE OSTIUM OF THE RIGHT EXTERNAL ILIAC. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED. THE ISSUE WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE. THE FSA STATED THAT THE DEVICE WAS LIKELY DEPLOYED IN THE INCORRECT POSITION DURING THE INDEX PROCEDURE, BUT IT WAS NOT NOTICED AT THE TIME BECAUSE THERE WAS A PIGTAIL CATHETER UP THAT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 16576684 ↗
• InjuryFeb 14, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2010, THE PATIENT HAD AN ABDOMINAL AORTIC ANEURYSM REPAIR USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2014, THE SUBJECT ENROLLED TO THE STUDY AND AT THIS DATE THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING ONLY A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (PLC201000/12522728) FOR A RIGHT COMMON ILIAC ARTERY ANEURYSM OF 20MM DIAMETER. REPORTEDLY, THE PRE-TREATMENT ABDOMINAL AORTIC ANEURYSM WAS 53MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2021, URINARY TRACT INFECTION AND INFECTION OF THE INFRARENAL ABDOMINAL AORTIC ANEURYSM STENT GRAFT WERE NOTED. THE PATIENT WAS HOSPITALIZED AND HER BLOOD CULTURES WERE POSITIVE WITH GRAM-NEGATIVE BACTEREMIA. REPORTEDLY, ON (B)(6) 2021, A LARGE RIGHT ILIAC FOSSA ABSCESS WAS NOTED. THE RIGHT ILIAC FOSSA ABSCESS WAS DRAINED AND TREATED WITH ANTIBIOTICS. THE PHYSICIAN RECOMMENDED TO REMOVE THE INFECTED AAA STENT GRAFTS AND DO EITHER BILATERAL AX FEM OR HOMOGRAFT REPAIR OF THE ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2021, A FOLLOW UP CT SHOWED THAT THE POSTOPERATIVE CHANGES OF AORTIC ANEURYSM REPAIR WITH INCREASED SIZE OF THE ANEURYSMAL SAC, IT WAS MEASURED UP TO 96 MM TRANSAXIALLY. ALSO, A PERSISTANT DISTAL

  Patient problems: Abdominal Pain; Aneurysm; Bacterial Infection; Clinical Endoleak; Ruptured Aneurysm; Sepsis

  MAUDE report 16376226 ↗
• DeathMay 7, 2022Complete Blockage; Complete Blockage

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABAORTIC ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENT REINTERVENTION TO TREATMENT A RUPTURE OF THE ANEURYSM. THE PHYSICIAN REPORTED THE GRAFT AT THE PROXIMAL NECK (INFRARENAL AORTA) WAS COLLAPSED IN, LIKE LOOKING AT A SLIVER OF THE MOON ON AN AXIAL CT. DURING THE PROCEDURE ANGIOPLASTY OF THE PREVIOUS GRAFT WAS PERFORMED AND THEN A 26MM GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT WAS IMPLANTED. THE PHYSICIAN SUSPECTS THE RUPTURE WAS CAUSED BY A PROXIMAL TYPE I ENDOLEAK CAUSED BY SOME BIRD BEAKING WHICH LED TO ENLARGEMENT AND THEN RUPTURE. THIS IS UNCONFIRMED DUE TO THE RUPTURE. POST IMPLANT COMPUTED TOMOGRAPHY THIS DAY SHOWED COMPRESSION AND OCCLUSION OF THE PROXIMAL DEVICE AND BILATERAL OCCLUSION WITHIN THE LIMBS ALSO. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, CTA SHOWED THE PROXIMAL END OF THE IMPLANTED DEVICE APPEARS FULLY EXPANDED AND APPEARED TO SHOW A THE TRUNK PORTION FULLY EXPANDED WITH FLOW RESTORED THROUGHOUT THE IMPLANTED D

  Patient problems: Aneurysm

  MAUDE report 14314027 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE HOSPITAL WITH A STABLE RUPTURED ABDOMINAL AORTIC ANEURYSM. ON COMPUTED TOMOGRAPHY, CONTRAST WAS SEEN IN THE ANEURYSM SAC AND IN THE RIGHT ILIAC ARTERY. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE HAD AN UNDIAGNOSED ENDOLEAK. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED WHEREBY A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS (PLA320400) WAS PLACED PROXIMALLY, AND A GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS (PLC201200) WAS PLACED IN THE RIGHT ILIAC ARTERY.

  Patient problems: Ruptured Aneurysm

  MAUDE report 14288969 ↗
• InjuryOct 21, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2013 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A DISTAL TYPE I ENDOLEAK DUE TO PROXIMAL MIGRATION OF A CONTRALATERAL LEG COMPONENT BACK INTO THE ANEURYSM SAC. DISEASE PROGRESSION WAS REPORTED TO HAVE CAUSED THE DEVICE TO REGRESS BACK INTO THE ANEURYSM SAC. THE ENDOLEAK WAS RESOLVED WITH PLACEMENT OF AN ADDITIONAL CONTRALATERAL LEG COMPONENT. NO ANEURYSM ENLARGEMENT WAS REPORTED JUST DISEASE PROGRESSION (ELONGATION).

  Patient problems: Aneurysm

  MAUDE report 12676888 ↗

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)