GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261414Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00733132622450), received between Sep 10, 2018 and Jan 30, 2026 — classified as 31 injuries, 5 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.

• InjuryJan 30, 2026Device Endoleak

  ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT261414). ON (B)(6) 2026, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT RECEIVED IMAGING REVEALING A TYPE 1A ENDOLEAK ON THE RLT261414, AND THE PHYSICIAN WAS PLANNING TO REINTERVENE. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THE ENDOLEAK AND CAUSE OF THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE TYPE 1A ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CXA260005). REPORTEDLY, THERE WAS STILL CONTRAST VISUALIZED AROUND THE ENDOPROSTHESIS IN POST-OP IMAGING, SO THE PHYSICIAN WAS NOT CERTAIN THAT THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN REPORTEDLY COULD NOT ADD ANY MORE EXTENSION PROXIMAL, AS THERE WAS NO ROOM FOR MORE EXTENSION. THE PHYSICIAN PLANS TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24225301 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, CONTRALATERAL LEG AND AN AORTIC EXTENDER). ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION TO PLACE A PROXIMAL GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DUE TO A SUSPECTED TYPE 1A ENDOLEAK AS IT DID NOT HAVE WALL APPOSITION ON THE PROXIMAL NECK AS IT WAS EXTREMELY ANGLED. REPORTEDLY, PATIENT WAS LOST TO FOLLOW UP AND THE ANEURYSM HAD INCREASED IN SIZE FROM 5.5 TO 8.5CM AND REINTERVENTION PROCEDURE WENT WELL WITH PATIENT DOING OKAY AFTER PROCEDURE

  Patient problems: Aneurysm expansion

  MAUDE report 23295307 ↗
• InjuryApr 29, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, THE FIELD SALES ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN THAT THERE IS A POSSIBLE TYPE 1A OR 2 ENDOLEAK ON THE PATIENT. PATIENT HAS TWO PAIRS OF LUMBAR ARTERIES AT THE PROXIMAL NECK, HENCE, ITS DIFFICULT TO DETERMINE THE TYPE OF ENDOLEAK. ON (B)(6) 2025, PHYSICIAN PLANS TO DO A REINTERVENTION VIA DIAGNOSTIC ANGIOGRAPHY AND CUFF EXTENSION AS THERE IS ANEURYSM GROWTH (SIZE UNKNOWN) AS WELL AND THERE ARE NO ISSUES WITH THE TWO CONTRALATERAL LIMBS. ADDITIONAL INFORMATION PROVIDED ON THE APRIL 15, 2025, REINTERVENTION: REPORTEDLY, IT WAS NOTED THAT PATIENT HAS A CONICAL NECK WITH TORTUOSITY AND THE EXCLUDER MAIN BODY GRAFT HAD A DISTAL MIGRATION OF 5MM. DURING THE REINTERVENTION, PHYSICIAN PLACED AN AORTIC EXTENDER WITH PROXIMAL EXTENSION AT THE LEVEL OF THE RENAL ARTERIES. THERE WAS NO ENDOLEAK PRESENT AFTER THE EXTENDER WAS PLACED AND PROCEDURE WAS SUCCESSFUL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21930677 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE, THAT ON (B)(6) 2020, BOTH RENAL ARTERIES OF A PATIENT HAVE BEEN COVERED DURING A PROCEDURE WHERE GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE IMPLANTED. FIVE HOURS LATER, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND ONE STENT OF UNKNOWN BRAND WAS IMPLANTED IN ONE OF THE RENAL ARTERIES TO PRESERVE THE BLOOD FLOW. IT WAS REPORTEDLY NOT POSSIBLE TO RECOVER THE FLOW TO THE SECOND RENAL ARTERY.

  Patient problems: Bacterial Infection; Obstruction/Occlusion

  MAUDE report 21751057 ↗
• InjuryMar 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE ANEURYSM SIZE AT THE TIME OF THE PROCEDURE IS UNAVAILABLE. AN RLT261414 TRUNK-IPSILATERAL LEG COMPONENT AND PLC201200 CONTRALATERAL LEG COMPONENT WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED DUE TO ANEURYSM ENLARGEMENT WITH NO APPARENT ENDOLEAK. NO GORE REPRESENTATIVE WAS PRESENT AT THE CASE. A PLC121400 CONTRALATERAL LEG COMPONENT, PLC141000 CONTRALATERAL LEG COMPONENT, AND PLA280300 AORTIC EXTENDER COMPONENT WERE USED TO TREAT THE ANEURYSM ENLARGEMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 21499584 ↗
• InjuryAug 21, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PATIENT WAS TREATED WITH EXTENSION OF THE IMPLANTED TRUNK IPSILATERAL LEG.

  Patient problems: Clinical Endoleak

  MAUDE report 20012012 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (RLT261414) AND TWO GORE® EXCLUDER® ENDOPROSTHESES (PLC161200 AND PLC181000) . THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION. THE PHYSICIAN HAD NOTED A GROWTH IN THE PREVIOUSLY TREATED ANEURYSM. THE PHYSICIAN WAS UNABLE TO FIND AN ENDOLEAK, BUT DECIDED TO IMPLANT A GORE® EXCLUDER® ENDOPROSTHESIS PROXIMAL TO THE ORIGINALLY IMPLANTED MAIN BODY. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 19149089 ↗
• InjuryFeb 20, 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) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS ADMITTED THROUGH THE HOSPITAL EMERGENCY DEPARTMENT WITH BACK PAIN. IT WAS REPORTED THAT IMAGES (MODALITY IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE WAS ANEURYSM SAC ENLARGEMENT DUE TO NO PREVIOUS IMAGES TO COMPARE TO. THE PATIENT HAD NEGLECTED FOLLOW UP VISITS WITH HIS PHYSICIAN. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. THERE WAS A REINTERVENTION ON (B)(6) 2024. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDERS IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18743415 ↗
• InjuryJan 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2021, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2023, PHYSICIAN CALLED THE FSA REPORTING IMAGING SCANS WERE REVIEWED FOR THIS PATIENT WHICH SHOWED A PROXIMAL TYPE 1 ENDOLEAK THAT WILL NEED REINTERVENTION SURGERY. FSA REPORTS PHYSICIAN WILL HAVE AN APPOINTMENT WITH THE PATIENT AT A LATER TIME TO DISCUSS THE REINTERVENTION SURGICAL PLAN. PHYSICIAN BELIEVES THIS ENDOLEAK IS A RESULT OF DISEASE PROGRESSION.

  Patient problems: Clinical Endoleak

  MAUDE report 18461505 ↗
• InjurySep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM AORTIC DIAMETER MEASURING 49.0MM; AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3 DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 49.0MM. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND TRANSCAVAL ENDOLEAK EMBOLIZATION AND COIL EMBOLIZATION OF THREE LUMBAR ARTERIES AND THE ANEURYSM SAC WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE, NO ANEURYSM DIAMETER WAS PROVIDED THIS DATE. ON (B)(6) 2020, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 55MM.

  Patient problems: Aneurysm expansion

  MAUDE report 17737881 ↗
• InjuryMay 30, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 55.5MM. ON SEPTEMBER 11, 2015, A TYPE II ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2017, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WHEREBY TRANSLUMBAR EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK (IT WAS REPORTED TO FDA ON AUGUST 24, 2017, MANUFACTURER REPORT NUMBER: 3007284313-2017-00209). FROM (B)(6) 2017 TO (B)(6) 2023, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 58MM TO 83MM. ON (B)(6) 2022, AN ANEURYSM ENLARGEMENT AND A CONTINUED TYPE II ENDOLEAK ORIGINATED FROM THE MIDDLE SACRAL ARTERY WERE IDENTIFIED. ON (B)(6) 2023, THE PATIENT UNDERWENT THE LASER FENESTRATION PROCEDURE OF THE RIGHT LIMB OF THE DEVICE AND THE ADDITIONAL ILIAC STENT WAS PLACED ON THE RIGHT SIDE. WHEN THE LASER WAS USED FOR BURNING THROUGH THE GRAFT, THEY WERE ABLE TO CROSS THE GRAFTOTOMY WITH A WIRE. THE PHYSICIAN USED A 5MM BALLOON TO DILATE THE GRAFTOTOMY. THEN, THE MULTIPLE MANIPULATIONS OF THE SHEATH AND A GUIDE CATHETER WERE USED. AFTER MULTIPLE INJE

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17027876 ↗
• MalfunctionMay 4, 2023Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT WAS TO BE IMPLANTED WITH A 26MM X 14CM GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER® DEVICE) TO TREAT ABDOMINAL AORTIC ANEURYSM. AFTER THE EXCLUDER® DEVICE WAS ADVANCED TO TARGET POSITION IN PATIENT, PHYSICIAN ROTATED THE WHITE HANDLE TO DEPLOY AT A CONSTANT SPEED. AFTER ALL THE DEPLOYMENT LINE WAS PULLED OUT, THERE WAS NO EXCLUDER® DEVICE EXPANSION UNDER FLUOROSCOPY. THEREFORE, A SHEATH (DSF1833) WAS USED AND DELIVERED TO THE PROXIMAL END OF THE EXCLUDER® DEVICE AND REMOVE THE DEVICE WITH SHEATH PROTECTION. THERE WAS NO CHANGE OBSERVED OF THE DEVICE AFTER IT WAS REMOVED OUT OF PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER EXCLUDER® DEVICE (RLT281412). PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866265 ↗
• InjuryMar 22, 2023Partial Blockage; Complete Blockage; Microbial Contamination of Device; Material Deformation; Partial Blockage; Complete Blockage; Microbial Contamination of Device; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH A ABDOMINAL AORTIC ANEURYSM AND AN LEFT COMMON ILIAC AORTIC ANEURYSM WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT261414, PLC181000, AND PLC121400). THE LEFT INTERNAL ILIAC AORTIC ANEURYSM WAS TREATED WITH EMBOLIZATION. THE TOTAL TREATMENT LENGTH WAS GREATER THAN 13 CM. THE AORTIC DIAMETER AT THE TIME OF TREATMENT WAS 22 MM. ON (B)(6) 2023, CT IMAGING SHOWED THAT AN ENDOPROSTHESIS (NOT FURTHER SPECIFIED) HAD COLLAPSED. ON MARCH 2, 2023, THE PATIENT WAS CONVERTED TO OPEN REPAIR. THE DEVICES WERE EXPLANTED. REPORTEDLY THE EXPLANTED DEVICE WAS POSITIVE TO STAPHYLOCOCCUS CHROMOGENES AND A THROMBUS WAS FOUND. THE LESION WAS TREATED WITH A NVC¿ BIOLOGICAL BIFURCATED VASCULAR GRAFT BIO MODIVASC® (BIO MODIVASC INC.) USED FOR INFECTED FIELDS OF TREATMENT. REPORTEDLY THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Bacterial Infection; Clinical Endoleak; Ischemia; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 16591671 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES DURING AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2021, A SMALL TYPE II ENDOLEAK WAS REPORTED SCHEDULED FOR AN EMBOLIZATION PROCEDURE THE FOLLOWING WEEK. ON (B)(6) 2021, THE TYPE II ENDOLEAK WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 15631130 ↗
• InjuryOct 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: DURING A SCHEDULED EVAR FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE DEVICES WERE SUCCESSFULLY IMPLANTED. DURING THE FINAL IMAGING A TYPE IA OR TYPE II ENDOLEAK WAS IDENTIFIED. AS REPORTED, THE PHYSICIAN DECIDED TO BALLOON THE GRAFT USING A NON-GORE BALLOON (CODA®). DURING THE BALLOONING A PORTION OF THE BALLOON EXTENDED PROXIMAL TO THE GRAFT. A RUPTURE OCCURRED AT THE TIME OF THE BALLOONING AND THE PATIENT WAS CONVERTED TO OPEN PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE AND DOING FINE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15531603 ↗
• InjurySep 2, 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) 2017, 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. IT WAS REPORTED THAT IMAGES (COMPUTED TOMOGRAPHY DATED JULY 14, 2022), REVEALED BILATERAL DISTAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK. CONTRALATERAL LEG ENDOPROSTHESES ARE IMPLANTED ON THE DISTAL ENDS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE EVENT IS ONGOING. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT, A REINTERVENTION IS PLANNED.

  Patient problems: Aneurysm

  MAUDE report 15351535 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2017, THIS PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES DURING AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2021, A TYPE II ENDOLEAK WAS DIAGNOSED AND SUBSEQUENTLY EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 14673487 ↗
• InjuryMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM MEASURING APPROXIMATELY 6CM DIAMETER AT THE RENALS AND APPROXIMATELY 8CM AT THE BIFURCATION, 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 FOLLOW-UP IMAGING FOR A SUSPECTED UNKNOWN ENDOLEAK AND ANEURYSM ENLARGEMENT. THE IMAGES WERE PROVIDED TO GORE AND AN EVALUATION SHOWED THE FOLLOWING: THE IMPLANTED ENDOGRAFT APPEARS TO COVER THE R RENAL ARTERY. PROXIMAL ENDOGRAFT TO R RENAL ARTERY ~ 11MM. CONTRAST IS VISUALIZED WITHIN THE R RENAL ARTERY BUT THE CONTRAST DOES NOT APPEAR TO ORIGINATE FROM THE AORTA. THERE APPEARS TO BE CONTRAST WITHIN THE ANEURYSM SAC. THE AVAILABLE IMAGES CANNOT RULE OUT OR CONFIRM A TYPE 1A ENDOLEAK. THERE APPEARS TO BE A LUMBAR ARTERY PERFUSED IN THE ARTERIAL PHASE AND COMMUNICATING WITH THE ANEURYSM SAC. THERE APPEARS TO BE A LUMBAR ARTERY COMMUNICATING WITH THE ANEURISM SAC WITHIN THE ARTERIAL PHASE WITH CONTRAST POOLING OBSERVED IN THE ARTERIAL AND DELAYED PHASE. THERE APPEARS TO BE A LUMBAR ARTERY COMMUNICATING WITH THE ANEURISM SAC WITHIN

  Patient problems: Aneurysm

  MAUDE report 14519752 ↗
• InjuryApr 29, 2022Patient-Device Incompatibility; Deformation Due to Compressive Stress; Material Twisted/Bent; Patient-Device Incompatibility; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. AROUND SIX WEEKS LATER, THE PATIENT PRESENTED WITH ISCHEMIA IN THE LEGS. UPON EXAMINATION, IT WAS FOUND THAT THE ENDOPROSTHESIS HAD FOLDED PROXIMALLY. THE PATIENT WAS TREATED WITH A THROMBECTOMY AND TWO BARE METAL STENTS WERE IMPLANTED TO SUPPORT THE ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 14251102 ↗
• InjuryNov 9, 2021Adverse 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 WITH A MAXIMUM DIAMETER OF 68 MM, AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM TO BE 74MM. ON (B)(6) 2016, FOLLOW-UP CTA DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM TO BE 75MM. ON (B)(6) 2016, THE PATIENT REQUIRED IN-PATIENT HOSPITALIZATION FOR A TYPE II ENDOLEAK AND ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2017, THE PATIENT UNDERWENT CATHETERIZATION OF THE AORTA, THE RIGHT INTERNAL ILIAC ARTERY AND SUPERIOR MESENTERIC ARTERY WITH ARTERIOGRAM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12780976 ↗
• MalfunctionJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I HEARD ABOUT A COMPLAINT ABOUT AN EXCLUDER TRUNK THAT HAPPENED IN (B)(6). OUR DISTRIBUTOR REP REPORTED THAT THE RLT WAS PREPARED ACCORDING IFU AND THEN INTRODUCED TO THE PATIENT. WHILE TRYING TO PLACE THE RLT INTO POSITION THE PHYSICIAN COMPLAINT ABOUT A RESISTANCES HE WAS FEELING. THE RESÍSTANSE INCREASED AND THE DEVICE GOT STUCK IN THE GUIDEWIRE, SO THEY DECIDED TO RETRIEVE THE DEVICE IN TANDEM WITH THE WIRE. OUTSIDE THE PATIENT, IN THE SURGERY TABLE, THEY TRIED TO PULL AND RELEASE THE DEVICE FROM THE WIRE BUT IT WAS NOT POSSIBLE, THIS PULLING DAMAGED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229946 ↗
• InjuryMar 24, 2021Migration; Migration

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2021, AN EMERGENT INTERVENTION WAS PERFORMED DUE TO ANEURYSM RUPTURE. IT WAS REPORTEDLY OBSERVED THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MIGRATED INTO THE ANEURYSM SAC. REPORTEDLY THE PATIENT'S PROXIMAL AORTIC NECK HAD A REVERSE TAPER WHICH WAS SUSPECTED MAY HAVE CONTRIBUTED TO THE DEVICE MIGRATION. FOUR GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS WERE IMPLANTED PROXIMALLY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11563748 ↗
• InjuryFeb 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THIS PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES DURING AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2021, AN EMERGENCY REINTERVENTION WAS PERFORMED TO TREAT A PERFORATED RUPTURE SUSPECTED TO HAVE BEEN CAUSED BY A TYPE 1A ENDOLEAK AND A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT PLA260300 WAS UTILIZED. AFTER DILATION WITH A RELIANT¿ STENT GRAFT BALLOON CATHETER, FINAL IMAGING SHOWED NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE ANEURYSM DIAMETER WAS NOW MEASURING 12 CM COMPARED TO 5.5 CM ORIGINALLY. IT WAS ALSO REPORTED THAT DUE TO THE PATIENT¿S SHORT AORTIC NECK, THE PHYSICIAN CONSIDERED TO IMPLANT A BRANCHED PROSTHESIS AT A LATER DATE.

  Patient problems: Aneurysm; Rupture; Ruptured Aneurysm

  MAUDE report 11324440 ↗
• InjuryJan 20, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. THE AORTIC SEAL ZONE WAS ONLY 15MM AND DID NOT MEET THE INCLUSION CRITERIA OF THE INSTRUCTIONS FOR USE. THEREFORE, THE PHYSICIAN ATTEMPTED TO SECURE THE TRUNK-IPSILATERAL LEG COMPONENT TO THE PROXIMAL AORTIC SEAL ZONE WITH STAPLES. ON (B)(6) 2020, THE PATIENT PRESENTED WITH THE TRUNK-IPSILATERAL LEG COMPONENT THAT HAD MIGRATED OUT OF PROXIMAL AORTIC NECK. THE STAPLES THAT WERE USED IN THE ORIGINAL PROCEDURE DID NOT HOLD. NO ANEURYSM ENLARGEMENT HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11203175 ↗
• MalfunctionDec 4, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER ADVANCING THE DEVICE TO THE INTENDED POSITION AND AFTER DEPLOYING THE PROXIMAL ENDOPROSTHESIS, IT WAS STATED THAT IT APPEARED DIFFICULT TO PERFORM THE IPSILATERAL LEG DEPLOYMENT AS THE HANDLE APPEARED TO BE BLOCKED. IT WAS NECESSARY TO PULL THE REMAINING DEPLOYMENT LINES ACCESSING THE BACKUP DEPLOYMENT HATCH. THE PROCEDURE WAS COMPLETED WITH FAVORABLE RESULTS AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10948168 ↗

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)