GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281416Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00733132622542), received between Jul 5, 2018 and Mar 23, 2026 — classified as 4 deaths, 26 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED SUCCESSFULLY IN A PATIENT WITH AN ABDOMINAL ANEURYSM. ON THE FOLLOW-UP CT 6 WEEKS POST-OPERATION, A COMPRESSION AT THE PROXIMAL END OF THE GRAFT WAS OBSERVED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED, THE COMPRESSION SECTION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS BALLOONED OPENED AND A BENTLEY AORTIC GRAFT WITH HIGH RADIAL FORCE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660568 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 54MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 54MM. ON (B)(6) 2025, THE PATIENT WAS CONVERTED TO OPEN REPAIR DUE TO RAPID EXPANSION OF THE ANEURYSM TO 87MM AND THE DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 22869237 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER THAT MEASURED 57MM; AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM (RLT281416/(B)(6), PXC141200/(B)(6). THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 56MM. ON (B)(6) 2022, THE PATIENT WAS REPORTED TO HAVE A TYPE II ENDOLEAK, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM WAS REPORTED TO MEASURE 50MM. ON (B)(6) 2024, THE PATIENT UNDERWENT LUMBAR EMBOLIZATION TO TREAT THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE, THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 57.6MM.

  Patient problems: Clinical Endoleak

  MAUDE report 22292981 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT WILL NEED A REINTERVENTION FOR A TYPE 1B ENDOLEAK WITH ANEURYSM GROWTH IN COMMON ILIAC ARTERY (16MM AT HYPO TAKEOFF). ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REVISION PROCEDURE TO A PRIOR EVAR UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, PHYSICIAN TREATED BY COILING THE LEFT HYPOGASTRIC ARTERY THEN EXTENDED DISTALLY INTO THE EXTERNAL ILIAC ARTERY WITH A CONTRALATERAL LEG. PROCEDURE WENT WELL AND PATIENT WAS DISCHARGED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21667994 ↗
• InjuryNov 14, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DR. YAVORSKI WAS THE IMPLANTING PHYSICIAN. A TRUNK-IPSILATERAL LEG COMPONENT AND AORTIC EXTENDER COMPONENT WERE IMPLANTED. ON AN UNKNOWN DATE, REPORTED AS SPRING OF 2024, DUPLEX SHOWED ANEURYSM EXCLUSION. THE ANEURYSM SAC MEASURED 5.5CM. ON (B)(6) 2024, DR. (B)(6) REQUESTED A REVIEW OF A CT SCAN BY THE GORE REPRESENTATIVE. THE CT SCAN SHOWED A SEPARATION OF THE AORTIC EXTENDER COMPONENT AND THE TRUNK MAIN BODY, RESULTING IN A TYPE III ENDOLEAK INTO THE AAA. THE ANEURYSM SAC MEASURED GREATER THAT 8CM. A PLAN FOR REINTERVENTION IS BEING EVALUATED BY THE GEISINGER VASCULAR GROUP. AN ENDOVASCULAR INTERVENTION IS BEING PLANNED WITH AN OPEN SURGICAL APPROACH IF THE ENDOVASCULAR OPTION FAILS.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20680321 ↗
• InjuryOct 10, 2024Device Endoleak; Device Endoleak

  THE FSA REPORTED THE FOLLOWING TO GORE: IT WAS REPORTED THAT THE PATIENT HAS A POTENTIAL ENDOLEAK. THE FSA WOULD NEED TO REVIEW THE FINDINGS AT A LATER TIME; HOWEVER, THE INITIAL FINDINGS MAY BE A TYPE 1A ENDOLEAK. IT IS UNKNOWN WHICH DEVICE IS CAUSING THE ENDOLEAK AT THIS TIME. AFTER REVIEWING THE FINDINGS, THE ENDOLEAK IS LESS LIKE TO BE A TYPE 1A , AND MORE LIKELY TO BE A TYPE 2 ENDOLEAK. THE PATIENT IS SCHEDULED ON (B)(6) 2024 TO DETERMINE WHAT TYPE OF ENDOLEAK IT MAY BE. THE PATIENT WILL BE TREATED DEPENDENT UPON WHAT IS FOUND. ON (B)(6), IT WAS DETERMINED TO BE A TYPE 1A ENDOLEAK ON THE IPSILATERAL LIMB. THE PHYSICIAN WILL BRING BACK THE PATIENT TO PUT IN A CUFF AND EXTEND UP TO THE SUPERIOR MESENTERIC ARTERY (SMA). THE PROCEDURE HAS NOT BEEN SCHEDULED AS OF NOW.

  Patient problems: Clinical Endoleak

  MAUDE report 20424330 ↗
• MalfunctionJan 24, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  THE PHYSICIAN FELT A LITTLE DIFFICULTY AT THE VALVE ON INSERTION BUT NOT EXCESSIVE. IT DIDN¿T APPEAR THAT ANY UNUSUAL FORCE WAS USED ON WITHDRAWAL.

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

  MAUDE report 18577117 ↗
• InjuryJan 17, 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) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED ¿SUSPECTED BILATERAL ILIAC ARTERY STENOSIS/GRAFT COMPRESSION INSIDE TREATED AREA¿. AN ANGIOGRAM AND EVALUATION FOR TREATMENT OF POSSIBLE BILATERAL ILIAC STENOSIS/GRAFT COMPRESSION WILL OCCUR ON JANUARY 04, 2024, WITH MAGGIE LIN, MD. EVENT IS ONGOING AT THIS TIME.

  Patient problems: Vasoconstriction

  MAUDE report 18528029 ↗
• DeathDec 12, 2022Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  ON (B)(6) 2016, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND CONTRA LEG. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM. THE PHYSICIAN BELIEVED THE DEVICE HAD MIGRATED, LEADING TO AN ANEURYSM RUPTURE. THE PATIENT EXPIRED BEFORE HE COULD BE TREATED. THE PHYSICIAN BELIEVES THE MIGRATION WAS DUE TO DISEASE PROGRESSION.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 15959493 ↗
• InjuryDec 9, 2022Adverse 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) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (CTA CHEST ABDOMEN/PELVIS), REVEALED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. THERE WAS A REINTERVENTION ON (B)(6) 2022. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESES AORTIC EXTENDER IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15950141 ↗
• InjuryNov 10, 2022Positioning Failure; Positioning Failure

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM THE PATIENT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON AN UNKNOWN DATE IN (B)(6) 2019, FOLLOW-UP IMAGING DETERMINED THE DIAMETER OF ANEURYSM SAC MEASURED 5.6 X 6 CM. ON AN UNKNOWN DATE IN (B)(6) 2022, A FOLLOW-UP IMAGING (NON-CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN) SHOWED GROWTH TO 6.2 X 6.5 CM. ON AN UNKNOWN DATE IN (B)(6) 2022, FOLLOW-UP IMAGING (DUPLEX EXAM) SHOWED A SUSPECTED TYPE II ENDOLEAK ON THE POSTERIOR ASPECT. ON OCTOBER 25, 2022, FOLLOW-UP IMAGING (ANGIOGRAM) WAS PERFORMED AND DETERMINED MIGRATION OF THE PROXIMAL END OF THE DEVICE. NO OBVIOUS ENDOLEAK WAS SEEN, BUT DUE TO THE GROWTH AND DISTAL MIGRATION OF AROUND 15 MM, THE PATIENT UNDERWENT REINTERVENTION AND TWO GORE® EXCLUDER® AORTIC EXTENDERS WERE PLACED TO EXTEND TO THE RIGHT RENAL ARTERY. THE RIGHT RENAL ARTERY WAS ALSO STENTED PRIOR TO IMPLANT OF THE AORTIC EXTENDERS DUE TO KNOWN STENOSIS. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Aneurysm expansion

  MAUDE report 15774579 ↗
• InjuryJul 13, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM (EVAR) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE COMPLETION ANGIOGRAM SHOWED GOOD POSITION OF THE DEVICE AND FILLING OF BOTH RENAL ARTERIES AND HYPOGASTRIC ARTERIES. THE PATIENT WAS REPORTEDLY SENT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2022, NEW ACUTE KIDNEY INJURY SUSPICIOUS FOR RENOVASCULAR HYPERTENSION WAS REPORTED. IT WAS REPORTED THAT THE ACUTE KIDNEY INJURY MAY BE RELATED TO CONTRAST INDUCED NEPHROPATHY AND/OR RENAL ISCHEMIA RELATED TO COVERING A RIGHT ACCESSORY RENAL ARTERY. IT WAS NOTED THAT, UPON FURTHER REVIEW OF IMAGING, THERE WAS CONCERN FOR INTRAOPERATIVE COVERAGE OF THE BILATERAL RENAL ARTERIES. IT WAS REPORTED THAT THE PHYSICIAN DISCUSSED OPTIONS FOR SUBSEQUENT CARE WITH THE PATIENT. IT WAS NOTED THAT THE PATIENT DID NOT WISH TO PROCEED WITH REINTERVENTION ON THE IMPLANTED DEVICE AND INSTEAD OPTED FOR PLACEMENT OF A HEMODIALYSIS (HD) CATHETER. THE HD CATHETER WAS PLACED ON THE SAME DAY AT THE PATIENT'S BEDSIDE USING ULTRASOUND GUIDANCE. LATER ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT HYPERTENSION

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 15009106 ↗
• InjuryMar 1, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2016 WITH AN ABDOMINAL AORTIC ANEURYSM (PRE-IMPLANT CT DIAMETER 54 MM) THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER AN INITIAL DECREASE OF THE ANEURYSM DIAMETER (ULTRASOUND 49 MM) IN 2017, MINOR ANEURYSM GROWTH WAS VISIBLE ON (B)(6) 2018 (ULTRASOUND 52 MM). ON (B)(6) 2021, A TYPE II ENDOLEAK ORIGINATING FROM LUMBAR ARTERIES WAS IDENTIFIED THAT CONTRIBUTED TO ADDITIONAL SIGNIFICANT ANEURYSM GROWTH (ULTRASOUND DIAMETER 66 MM). ON (B)(6) 2021, THE ENDOLEAK WAS SUCCESSFULLY TREATED WITH EMBOLIZATION OF THE LUMBAR ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13630591 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, A CT SCAN SHOWED A TYPE II ENDOLEAK. THE PHYSICIAN PERFORMED AN ENDLEAK EMBOLIZATION.

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

  MAUDE report 12647934 ↗
• InjuryJun 3, 2021Adverse 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 ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). ON (B)(6) 2021 THERE WAS A REINTERVENTION. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER AND A PALMAZ STENT. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11935354 ↗
• MalfunctionMay 6, 2021Material Protrusion/Extrusion; Sharp Edges; Material Protrusion/Extrusion; Sharp Edges

  ON (B)(6), 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PRIOR TO THE PROCEDURE, A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT281416 WAS INSPECTED AND PREPARED AND NO ABNORMALITIES WERE OBSERVED. AS UNUSUAL RESISTANCE WAS FELT WHEN ATTEMPTING TO ADVANCE THE COMPONENT THROUGH AN 18 FRENCH GORE® DRY SEAL FLEX INTRODUCER SHEATH INSIDE THE PATIENT, THE PHYSICIAN RETRACTED THE RLT281416 DEVICE CATHETER OUT OF THE SHEATH. HOWEVER, IT WAS REPORTED THAT DURING AN IMMEDIATE RENEWED ADVANCEMENT ATTEMPT, THE COMPONENT BECAME STUCK DUE TO THE RESISTANCE ACCOMPANIED BY A SUDDEN CONSIDERABLE GUSH OF BLOOD OUT OF THE SHEATH. AS IT WAS SURMISED THE SHEATH WAS DAMAGED, IT WAS RETRACTED FROM THE PATIENT TOGETHER WITH THE RLT281416 COMPONENT. SUBSEQUENTLY, THE WOUND IN THE LEFT GROIN WAS PRESSURED AGAINST WITH A GAUZE AND THE RLT281416 CATHETER WAS INSPECTED. IT WAS FOUND THAT THE LOCK PIN WAS PROTRUDING IN A 90 DEGREE ANGLE JUST BELOW THE LEADING OLIVE. THE SHEATH WAS NOT PARTICULARLY INSPECTED BUT IT WAS REPORTEDLY BELIEVED THAT THE PROTRUDING LOCK PIN HAD PERFORATED THE INFLATED VALVE, POINTING

  Patient problems: Failure of Implant

  MAUDE report 11787084 ↗
• InjuryJan 29, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE DEVICES DUE TO INFECTION. THE CAUSE OF THE INFECTION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11254794 ↗
• DeathJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THERE WAS AN UNRESOLVED PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN CHOSE TO EXPLANT THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND CONVERT TO OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, DURING PROCEDURE, THERE WAS A TIME WHEN CHEST COMPRESSIONS WERE PERFORMED. THE PATIENT HAD PREVIOUS HEART STENTS IMPLANTED. LATER THAT DAY ON (B)(6) 2020, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 11217689 ↗
• InjuryJan 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER ® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT HAD SEVERE ANGULATED NECK THAT WAS OUTSIDE OF SIZING GUIDELINES IN THE INSTRUCTIONS FOR USE. ON (B)(6) 2020, THE PATIENT WAS TREATED FOR MIGRATION AND PROXIMAL TYPE I ENDOLEAK. THERE WAS NO INDICATION OF ANEURYSM ENLARGEMENT. THE PHYSICIAN ATTRIBUTES THE MIGRATION TO THE SEVERE NECK ANGULATION AND DISEASE PROGRESSION. THE PATIENT WAS IMPLANTED WITH A MEDTRONIC AORTIC CUFF AND 5 MEDTRONIC AORTIC ANCHORS. THE PROCEDURE WENT WELL, AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 11114031 ↗
• DeathDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A TUBE GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RUPTURED ILIAC ANEURYSM. THE PHYSICIAN HAD PLANNED TO INTERVENE AND COIL THE HYPOGASTRIC ARTERY AND THEN IMPLANT GORE® EXCLUDER® AAA ENDOPROSTHESIS TO CONTAIN THE RUPTURED ANEURYSM. THERE WERE MULTIPLE ISSUES WHILE ATTEMPTING TO ADVANCE THE GUIDEWIRES. THE PHYSICIAN THEN ATTEMPTED AN AUI. THE AUI WAS SUCCESSFUL AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. HOWEVER, A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. THE PHYSICIAN WANTED TO TAKE A WAIT AND APPROACH ON ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. LATER THAT DAY ON (B)(6) 2020, THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE ON THE CAUSE OF DEATH.

  Patient problems: Aneurysm

  MAUDE report 11083485 ↗
• MalfunctionOct 21, 2020Difficult to Open or Close; Difficult to Open or Close

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICE WAS ADVANCED FROM FEMORAL ARTERY TO THE TARGET LESION. WHEN THE PHYSICIAN PULLED THE INITIAL DEPLOYMENT LINE, THE TRUNK-IPSILATERAL LEG COMPONENT DIDN'T FULLY OPEN. THE CONSTRAINING MECHANISM DIDN'T WORK, WHEN THE PHYSICIAN TRIED TO CONSTRAIN THE PROXIMAL END. THEREFORE, THE PHYSICIAN RETRACTED THE DELIVERY CATHETER. AFTER DILATION WITH CODA BALLOON, THE TRUNK-IPSILATERAL LEG COMPONENT FULLY OPENED. HOWEVER, IT MOVED DISTALLY. THEREFORE, AN AORTIC EXTENDER COMPONENT WAS PLACED IN THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PATIENT TOLERANT THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10715920 ↗
• InjuryOct 2, 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. REPORTEDLY, DURING THE ORIGINAL PROCEDURE TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE USED FOR A CHIMNEY TECHNIQUE IN THE RENAL ARTERIES (LOT/SERIAL NUMBER IS UNKNOWN AND NOT AVAILABLE). IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2020, REVEALED THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT (PREVIOUS CT IMAGES ARE NOT AVAILABLE FOR COMPARISON). THE CAUSE FOR THE TYPE I ENDOLEAK IS UNKNOWN, BUT THE PHYSICIAN STATED "IT COULD BE POSSIBLE GUTTERS THAT LEAD TO POSSIBLE MIGRATION". ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS PROXIMALLY AND BILATERALLY EXTENDED PROXIMALLY BOTH VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE ENDOLEAK WAS RESOLVED AT THE END OF THE CASE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10622132 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2015, WITH A 60 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM SIZE APPEARED TO BE STABLE UNTIL ANEURYSM GROWTH WAS VISIBLE ON (B)(6) 2018 (68 MM). ON (B)(6) 2020, A TYPE II ENDOLEAK WAS IDENTIFIED ALONG WITH FURTHER ANEURYSM GROWTH TO 80MM. THE ENDOLEAK WAS SUCCESSFULLY TREATED WITH EMBOLIZATION ON (B)(6) 2020. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10404781 ↗
• InjuryAug 10, 2020Patient-Device Incompatibility; Deformation Due to Compressive Stress; Patient-Device Incompatibility; Deformation Due to Compressive Stress

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY PLACED STENT GRAFTS. THE PATIENT'S ANATOMY WAS REPORTED AS TORTUOUS AND HIGHLY CALCIFIED THROUGH THE AORTA AND ILIAC ARTERIES. IT WAS REPORTED THAT WHEN THE TRUNK OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED, THE CONTRALATERAL LEG GATE BECAME COMPRESSED DUE TO ITS PLACEMENT IN A HIGHLY TORTUOUS AND CALCIFIED AREA OF THE ANATOMY. THE CONTRALATERAL LEG GATE WAS UNABLE TO BE CANNULATED. IT WAS REPORTED THAT THE PHYSICIAN CONVERTED TO AN OPEN PROCEDURE. THE TRUNK-IPSILATERAL LEG COMPONENT WAS EXPLANTED. UPON EXPLANT IT WAS NOTED THAT THE CONTRALATERAL LEG GATE WAS CRUSHED. THE CRUSHED CONTRALATERAL LEG GATE WAS ATTRIBUTED SOLELY TO PATIENT ANATOMY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388620 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, DURING A FOLLOW UP VISIT, IMAGING REVEALED A SUSPECTED TYPE I ENDOLEAK, WHICH CAUSED THE ANEURYSMAL SAC TO ENLARGE BY AN UNKNOWN AMOUNT. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON EACH SIDE TO TREAT THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN HAD NO OPINION REGARDING THE CAUSE OF THE ENDOLEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10206511 ↗

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