GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT231418Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00733132622399), received between Aug 2, 2018 and Jun 30, 2025 — classified as 1 death, 18 injuries, 3 malfunctions.

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

• InjuryJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, THE PHYSICIAN NOTIFIED THE FIELD SALES ASSOCIATE (FSA) THAT A REINTERVENTION WILL BE DONE ON (B)(6) 2025 TO TREAT A TYPE 1A ENDOLEAK WITH PROXIMAL AORTIC EXTENDERS. ON (B)(6) 2025, THE PATIENT UNDERWENT AN REINTERVENTION WITH PROXIMAL EXTENSION TO TREAT THE TYPE 1A ENDOLEAK. FSA WAS NOT PRESENT FOR THE REINTERVENTION PROCEDURE AND FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22358295 ↗
• MalfunctionMar 26, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN DEPLOYING THE MAIN BODY, THE HANDLE WAS ¿TIGHT WHEN TURNING¿. THE FIELD SALES ASSOCIATE SUGGESTED TURNING THE WHITE OUTER DEPLOYMENT KNOB COUNTERCLOCKWISE AND THEN TO THE RIGHT (STARTING POSITION) AND THEN TRIED TO DEPLOY AGAIN AND THE DEVICE DEPLOYED. DURING THE RELEASE OF THE DEVICE THE CONSTRAINING SLEEVE BECAME DISCONNECTED AND WAS PULLED OUT. THE GRAPH DEPLOYED 3CM DISTAL OF THE INTENDED LANDING ZONE. THE PHYSICIAN CORRECTED WITH AN AORTIC EXTENDER ENDOPROSTHESIS. THE ZONE WAS SEALED, AND THE PATIENT TOLERATED THE PROCEDURE. THE CONSTRAINING MECHANISM WAS NOT USED FOR THIS PROCEDURE. THERE WERE NO ANATOMY ANOMALIES. THE DELIVERY CATHETER WAS DESTROYED AT THE HOSPITAL.

  Patient problems: Aneurysm

  MAUDE report 21696796 ↗
• InjuryOct 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUPPLEMENTAL INFO: THE PATIENT HAD A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS ADMITTED TO THE EMERGENCY ON MAY 16TH.

  Patient problems: Ischemia

  MAUDE report 20490349 ↗
• MalfunctionSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE THIRD DEPLOYMENT, THE IPSILATERAL LIMB DID NOT DEPLOY. THE BACK UP HATCH WAS USED; THE DEVICE DEPLOYED COMPLETELY AND WAS IMPLANTED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 20214969 ↗
• DeathAug 14, 2024Collapse; Material Invagination; Use of Device Problem; Obstruction of Flow; Patient-Device Incompatibility; Migration; Collapse; Material Invagination; Use of Device Problem; Obstruction of Flow; Patient-Device Incompatibility; Migration

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. NO ISSUES WITH THE DEVICE PLACEMENT OR AN ENDOLEAK WERE DETECTED AT THE TIME OF IMPLANTATION. THE PATIENT HAD A FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IN (B)(6) 2024, AND THERE WERE NO ISSUES NOTED WITH THE DEVICE OR ITS PLACEMENT. REPORTEDLY, ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL ACUTELY WITH ABDOMINAL SYMPTOMS. THE CT WAS PERFORMED ON AND THE STENT WAS NOTED TO HAVE MIGRATED DISTALLY (UNKNOWN) AND APPEARS TO HAVE FOLDED INWARDS. THE GRAFT ON ACUTE ADMISSION SCAN WAS COMPLETELY COLLAPSED. REPORTEDLY, THE DIAMETER OF THE AORTA WHERE THE DEVICE WAS POSITIONED REMEASURED WITHOUT STRAIGHTENING PROGRAM USING MPR AND WAS 22.5MM RIGHT AT RENTALS, 21 MM MID NECK AND 18 MM JUST DISTAL. IT WAS REPORTED THAT THE DEVICE MIGRATION WAS PERHAPS DUE TO THE UNDERSIZED GRAFT BUT THE PHYSICIAN DID OVERSIZE BY 15 % LACK OF SUPRA RENAL FIXATION. IT WAS REPORTED THAT ACUTELY THE INFRARENAL AORTA WAS OCCLUDED, AND WHOLE GRAFT OCCLUDED AND COLLAPSED WAS PULLED OUT OF NECK BASICALLY. THE PALLIATIVE CARE WAS

  Patient problems: Foreign Body Embolism; Ischemia; Reduced Blood Flow

  MAUDE report 19988344 ↗
• InjuryJul 11, 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) 2015, 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 FOLLOW UP IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A TYPE II ENDOLEAK, FROM THE ILIOLUMBAR ARTERY IN THE LEFT INTERNAL ILIAC ARTERY. THERE WAS ANEURYSM SAC ENLARGEMENT OF 10MM. ON (B)(6) 2024, THE PHYSICIAN REINTERVENED AND EMBOLIZED THE ILIOLUMBAR ARTERY VESSEL WITH COILS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19726466 ↗
• InjuryMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 54.9 MM IN DIAMETER AND WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231418/12724128). THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), 2014. ON (B)(6), 2014, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DETERMINED THE MAXIUMUM ANEURYSM DIAMETER MEASURED 55MM. ON (B)(6), 2019, A TYPE II ENDOLEAK WAS REPORTED. ON (B)(6), 2023, THE PATIENT UNDERWENT REINTERVENTION AND AN AORTOGRAM WITH CATHETERIZATION AND COIL EMBOLIZATION OF THE SUPRARENAL AORTIC BRANCH ARTERY CONSISTENT WITH LEFT LUMBAR ARTERY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2024, FOLLOW-UP CT DETERMINED THE MAXIUMUM ANEURYSM DIAMETER MEASURED 88 MM.

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

  MAUDE report 19388207 ↗
• InjuryDec 6, 2023Adverse 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) 2023, 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 THE GORE® EXCLUDER® AAA ENDOPROSTHESES HAD THROMBOSED. THERE WAS A REINTERVENTION ON NOVEMBER 03, 2023. THE PHYSICIAN PERFORMED AN OPEN CONVERSION AND EXPLANTED THE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 18273707 ↗
• InjuryJun 23, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK WHEREBY AN AORTIC EXTENDER COMPONENT WAS USED FOR PROXIMAL EXTENSION OF THE TRUNK-IPSILATERAL LEG COMPONENT. ON (B)(6) 2023, THE PHYSICIAN NOTIFIED THE GORE REPRESENTATIVE THAT A REINTERVENTION WAS PLANNED FOR ENDOLEAK TREATMENT. THE GORE REPRESENTATIVE ALSO BECAME AWARE OF THE PREVIOUS REINTERVENTION AT THIS TIME. ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT OF A DISTAL TYPE I ENDOLEAK ON THE IPSILATERAL LEG COMPONENT IMPLANTED ON THE PATIENT'S RIGHT SIDE. ABDOMINAL AORTIC ANEURYSM ENLARGEMENT WAS ALSO OBSERVED (AMOUNT UNKNOWN). THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND DISTAL EXTENSION OF THE RIGHT LIMB WAS PERFORMED USING A CONTRALATERAL LEG COMPONENT. THE ENDOLEAK WAS RESOLVED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17190123 ↗
• InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT RE-INTERVENTION FOR A SUSPECTED TYPE II ENDOLEAK AND THE PROXIMAL TRUNK WAS REINFORCED WITH TWO HELI-FX¿ ENDOANCHOR¿ SYSTEM. THE PHYSICIAN REPORTED THAT THERE APPEARED TO BE A LACK OF APPOSITION AND CONTACT OF THE POSTERIOR WALL OF THE DEVICE AND THE VESSEL AND HE CHOSE TO PLACE THE ANCHORS AS ANEURYSM ENLARGEMENT PERSISTED. THE AMOUNT OF ENLARGEMENT WAS NOT KNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 16856737 ↗
• InjuryMar 7, 2023Material Puncture/Hole; Material Puncture/Hole

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING A FOLLOW-UP ON (B)(6) 2023, REPORTEDLY, AN ANGIOGRAPHY WAS DONE, AND THE PHYSICIAN'S TEAM ONLY SHARED A PHOTO, WHICH SHOWED AN APPARENT TYPE 3 ENDOLEAK ON THE PATIENT'S LEFT SIDE DUE TO A HOLE IN THE EXCLUDER GRAFT THAT WAS PREVIOUSLY IMPLANTED. ON (B)(6) 2023, REPORTEDLY, THE PATIENT UNDERWENT A ZONE 9-INFRARENAL REINTERVENTION TO TREAT THE TYPE 3 ENDOLEAK BY ADDING AN AORTIC EXTENDER TO EXTEND COMPLETELY INSIDE THE GRAFT OF THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231418). AN ANGIOGRAPHY WAS DONE WITH NO RUN (CONTRAST DYE). THE TYPE 3 ENDOLEAK WAS RESOLVED AT THE END OF THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE. IMAGING EVALUATION SUMMARY: JPG IMAGE RECEIVED VIA EMAIL WITH NO PATIENT IDENTIFIER OR DATE OF ACQUISITION IN IMAGE. UNABLE TO CONFIRM THE REPORTED TYPE III ENDOLEAK WITH THE AVAILABLE IMAGE SUBMITTED. ENGINEERING EVALUATION SUMMARY: THIS EVALUATION IS BASED ON THE EVENT DESCRIPTION AS REPORTED TO GORE AND AN IMAGE ATTACHED TO SMARTSOLVE INCLUDING AN IMAGING EVALUATION. THE DEVICE WAS NOT

  Patient problems: Clinical Endoleak

  MAUDE report 16494993 ↗
• InjuryDec 12, 2022Adverse 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. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND CONTRALATERAL LEG WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. DURING FOLLOW UP ON AN UNKNOWN DATE, THE PHYSICIAN NOTED ANEURYSM GROWTH PROXIMAL TO THE TRUNK DEVICE. WHICH EXTENDED UP TO APPROXIMATELY 1CM BELOW THE RENALS. ALTHOUGH NO ENDOLEAK WAS OBSERVED, THE PHYSICIAN DECIDED TO IMPLANT AN EXTENDER PROXIMAL TO THE TRUNK DEVICE, EXTENDING UP TO THE RENALS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THE ANEURYSM ENLARGEMENT WAS DUE TO DISEASE PROGRESSION.

  Patient problems: Aneurysm expansion

  MAUDE report 15959080 ↗
• InjuryNov 4, 2022Obstruction of Flow; Obstruction of Flow

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM IN ZONE 9 WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY DURING THE PROCEDURE ON (B)(6) 2022, THE PATIENT HAD A HIGH DEGREE OF ANGULATION IN THE COMMON ILIAC ARTERIES AND EXTERNAL ILIAC ARTERIES. THE LEFT SIDE (WHICH WAS THE SIDE OF THE CONTRALATERAL LIMB) APPEARED TO HAVE A KINK IN THE NATIVE COMMON ILIAC ARTERY FROM THE SHARP TURN IN THE ARTERY. THE TORTUOSITY DID CAUSE SOME PROBLEMS WITH GETTING THE WIRES AND SHEATHS UP ON BOTH SIDES, BUT THE PHYSICIAN WAS ABLE TO TRAVERSE BOTH SIDES AND THEN EXCHANGE FOR STIFF WIRES, WHICH HELPED STRAIGHTEN THE ANATOMY OUT. IN THE FINAL ANGIO RUN AT END OF PROCEDURE, IT WAS NOTED THE CONTRA LATERAL LIMB COMING AROUND THAT SHARP BEND IN THE COMMON ILIAC ARTERY. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO EMERGENCY ROOM. IT WAS DETERMINED THAT THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS COLLAPSED FROM THE SUPERIOR LEADING EDGE, ALL THE WAY DOWN TO THE DISTAL PORTION OF THE IPSILATERAL LIMB JUST ABOVE THE RIGHT HYPOGASTR

  Patient problems: Aneurysm

  MAUDE report 15729467 ↗
• InjuryJun 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. AS REPORTED, THE PROCEDURE WAS GOING AS PLANNED UNTIL THE IPSILATERAL LIMB MOVED PROXIMALLY INTO THE ANEURYSM. AS REPORTED THERE WAS NOT ENOUGH LIMB IN THE ILIAC AND WHEN THE STIFF WIRE WAS PULLED BACK IT BROUGHT THE IPSILATERAL COMPONENT WITH IT. AS REPORTED, THE GORE REPRESENTATIVE ONSITE RECOMMENDED EXTENDING THE GRAFT WITH ADDITIONAL COMPONENTS INTO THE RIGHT ILIAC. THE PHYSICIAN DECIDED NOT TO ADD ANY ADDITIONAL COMPONENTS. DURING FOLLOW UP, ON AN UNSPECIFIED DATE, A DISTAL TYPE 1 ENDOLEAK WAS IDENTIFIED DOWN THE RIGHT SIDE OF THE PATIENT. ON (B)(6) 2022 A REINTERVENTION WAS CARRIED OUT IN WHICH A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LIMB (PLC141000) WAS IMPLANTED TO EXTEND THE EXISTING GRAFT FURTHER INTO THE RIGHT ILIAC IN ORDER TO TREAT THE DISTAL TYPE I ENDOLEAK. AS REPORTED, THE PROCEDURE WENT WELL.

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

  MAUDE report 14685733 ↗
• MalfunctionMay 7, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231418), WHICH WAS INTENDED TO BE USED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), WOULD NOT ADVANCE THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1633). AN ALTERNATIVE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231416) WAS USED INSTEAD AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315992 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 3016 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2016, DURING FOLLOW UP, THE ANEURYSM MEASURED 52 MM. ON (B)(6) 2020, DURING FOLLOW UP, THE ANEURYSM MEASURED 59 MM. ON (B)(6) 2021, DURING FOLLOW UP, THE ANEURYSM MEASURED 64 MM, AND A TYPE II ENDOLEAK WAS DISCOVERED. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED WHEREBY THE TYPE II ENDOLEAK WAS TREATED WITH COIL EMBOLIZATION.

  Patient problems: Aneurysm

  MAUDE report 13096392 ↗
• InjuryJun 28, 2021Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM WAS IMPLANTED, ALONG WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT REPORTED EMERGENTLY WITH LEG PAIN AFTER STRENUOUS WORK. IMAGING REVEALED THE LEFT LEG OF THE TRUNK DEVICE WAS COMPLETELY OCCLUDED. THE PATIENT WAS TRANSFERRED TO A HOSPITAL IN MADISON, WI FOR TREATMENT. THERE, DR. ARCHER DID AN OPEN PROCEDURE AND EXPLANTED THE DEVICE. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE PHYSICIAN HAS NO OPINION REGARDING THE CAUSE OF THE OCCLUSION.

  Patient problems: Pain

  MAUDE report 12075765 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH COLD LEGS. COMPUTED TOMOGRAPHY SCANS REVEALED THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS HAD FOLDED OVER ON ITSELF (1800-E OTHER/UNKNOWN). ¿THE FLOW DIVIDER WAS ALSO KINKED/FOLDED LIKE A PANCAKE.¿ THERE WAS ALSO THROMBUS THROUGHOUT PATIENTS COMMON/EXTERNAL ILIAC ARTERIES. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED. HE PLACED A 10X40MM PALMAZ STENT IN THE PROXIMAL TRUNK-IPSILATERAL LEG ENDOPROSTHESIS UP TO RENAL ARTERIES. THEN PLACED TWO 11 X 59 VBX STENTS FROM THE FLOW DIVIDER DOWN DISTALLY. AFTER THOSE STENTS WERE PLACED, THEY RELINED THE RIGHT COMMON ILIAC ARTERY WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC181400). A CONTRALATERAL LEG ENDOPROSTHESIS (PLC141200) WAS PLACED IN THE LEFT COMMON ILIAC ARTERY. AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS (PLC181200) WAS PLACED IN THE DISTAL RIGHT COMMON ILIAC ARTERY TO COVER THROMBUS. REPORTEDLY THE PATIENT DID NOT HAVE TORTUOUS ANATOMY, IT IS UNKNOWN WHAT CAUSED THE EVENT. THE PATIENT TOLERATED T

  Patient problems: Aneurysm

  MAUDE report 10929080 ↗
• InjuryJun 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2019, A TYPE II ENDOLEAK WAS DISCOVERED. ANEURYSM ENLARGEMENT GREATER THAN 5MM WAS ALSO NOTED. ON (B)(6) 2019, AN AORTOGRAM WITH EMBOLIZATION AND CATHETERIZATION OF THREE SEPARATE BRANCHES OF LT INTERNAL ILIAC ARTERY WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 10153785 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS BEING IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER FIVE ATTEMPTS OF RECONSTRAINING AND REPOSITIONING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT281418/21067318), THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE LOCK PIN WIRE HAD PROTRUDED OUT OF THE OLIVE TIP AND APPEARED TO BE PENETRATING THE AORTA. THE PHYSICIAN WAS OK WITH THE POSITION OF THE DEVICE AND DECIDED TO FULLY DEPLOY THE DEVICE. FLUOROSCOPY WAS DONE AFTER DEPLOYMENT AT SEVERAL ANGLES, THERE WAS NO EVIDENCE OF A RUPTURED AORTA OR COMPLETE/FULL PENETRATION THROUGH THE AORTA AND NO CONTRAST OUTSIDE THE AORTA. THE DEVICE WAS DEPLOYED IN ACCURATE PLACE AND THERE WAS NO FURTHER SEQUELA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9693172 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, IMAGING IDENTIFIED 3CM OF ANEURYSM GROWTH DUE TO AN UNKNOWN CAUSE. IT WAS REPORTED NO ENDOLEAK COULD BE OBSERVED. ON THE SAME DAY, THE ENTIRE SYSTEM WAS RELINED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT THE ANEURYSM GROWTH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7928561 ↗
• InjuryAug 2, 2018Partial Blockage; Deformation Due to Compressive Stress; Partial Blockage; Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND AN ANEURYSM IN THE LEFT INTERNAL ILIAC ARTERY THAT WERE SUCCESSFULLY TREATED WITH GORE® EXCLUDER® AAA AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). IT WAS STATED THAT NO ISSUES OCCURRED DURING THE IMPLANT PROCEDURE AND THAT THE FINAL IMAGING WAS VERY SATISFYING. ON (B)(6) 2018, THE PATIENT PRESENTED VERY STRONG PAIN IN THE STOMACH REGION TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL. IMAGING REVEALED A COLLAPSED TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, CAUSED BY THROMBUS THAT DEVELOPED BETWEEN THE AORTA AND THE DEVICE. ACCORDING TO THE PHYSICIAN THE PATIENT STOPPED USING THE ANTIPLATELET DRUG THAT HE SHOULD HAVE TAKEN. DURING A REINTERVENTION PROCEDURE THE THROMBUS WAS REMOVED AND THE DEVICE BALLOONED WITH FAVORABLE RESULTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7741730 ↗

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)