GORE EXCLUDER AAA Endoprosthesis PLC201400Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00733132618552), received between Jul 16, 2018 and Jul 27, 2026 — classified as 1 death, 23 injuries, 4 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Endoleak

  The following was reported: On (b)(6) 2026, the patient underwent endovascular treatment as a planned endovascular procedure for an abdominal aortic aneurysm. The patient was treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprostheses. The GORE® devices were successfully implanted. The patient was discharged on (b)(6) 2026. On (b)(6) 2026, the patient underwent a CTA. GIS noted that the patient had a Type II Endoleak. The clinical site reported that the patient had a Type IA Endoleak. The physician stated that a reintervention procedure is scheduled for (b)(6) 2026.

  Patient problems: Clinical Endoleak

  MAUDE report 50046107 ↗
• InjuryApr 30, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMAGING DATABASE, IMEDIDATA BASE, CLINICAL SITE AND FIELD SALES ASSOCIATE: IN 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE. THE MANUFACTURER OF THE DEVICE(S) COULD NOT BE CONFIRMED; HOWEVER, NO ADDITIONAL INFORMATION REGARDING THIS PROCEDURE IS AVAILABLE. ON (B)(6), 2024, THE PATIENT UNDERWENT A CHIMNEY/SNORKEL ENDOVASCULAR REPAIR IN ZONE 6 (CELIAC) UTILIZING THE GORE® EXCLUDER® THORACIC STENT GRAFT, GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ON (B)(6), 2024, THE PATIENT UNDERWENT AN ADDITIONAL ENDOVASCULAR PROCEDURE FOR AN ANEURYSM IN ZONE 6 (CELIAC). THIS WAS BELIEVED TO HAVE BEEN PART OF A STAGED REPAIR. ON (B)(6), 2026, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A TYPE 1B ENDOLEAK. BILATERAL GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE IMPLANTED, SUCCESSFULLY RESOLVING THE ENDOLEAK. THE PATIENT WAS DISCHARGED ON (B)(6), 2026. ON (B)(6), 2026, IMAGING IDENTIFIED A TYPE II ENDOLEAK AND AN INDETERMINATE ENDOLEAK. NO FURTHER TREATMENT HAS BEEN PERFORMED TO DATE.

  Patient problems: Clinical Endoleak

  MAUDE report 25049008 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component; Device Damaged by Another Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, DURING ENDOVASCULAR ANEURYSM REPAIR USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) DELIVERED THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1233), THE DEVICE BECAME STUCK WITHIN THE SHEATH IMMEDIATELY AFTER PASSING THE VALVE AND COULD NOT BE ADVANCED FURTHER. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO WITHDRAW THE UNDEPLOYED DEVICE THROUGH THE SHEATH, AT WHICH TIME RESISTANCE WAS ENCOUNTERED. DURING WITHDRAWAL, THE LIMB SEPARATED FROM THE DELIVERY CATHETER AND REMAINED LODGED WITHIN THE SHEATH. THE DELIVERY CATHETER WAS REMOVED, AND THE SHEATH CONTAINING THE LIMB WAS SUBSEQUENTLY REMOVED TOGETHER FROM THE PATIENT. NO PORTION OF THE DEVICE OR SHEATH REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ADVERSE OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662285 ↗
• InjuryAug 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN DISEASE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, AND TWO CONTRALATERAL LEGS). ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG). REPORTEDLY, PATIENT HAD A TYPE 1B ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND COVERED DOWN TO THE RIGHT EXTERNAL ILIAC ARTERY WITH A CONTRALATERAL LIMB. ENDOLEAK WAS RESOLVED. PATIENT TOLERATED THE PROCEDURE. PHYSICIAN PROVIDED THE CAUSE OF THE ENDOLEAK WAS DUE TO CONTINUED ANEURYSMAL GROWTH (SIZE UNKNOWN) OF THE RIGHT COMMON ILIAC ARTERY DUE TO ANEURYSM DISEASE.

  Patient problems: Clinical Endoleak

  MAUDE report 22816433 ↗
• InjuryMar 21, 2025Obstruction of Flow; Poor Visibility; Obstruction of Flow; Poor Visibility

  ON (B)(6) 2025, THE PATIENT PRESENTED AT THE EMERGENCY WITH PAIN AND VOMITING, AND UPON THE SCANNING IT WAS AN INCIDENTAL FINDING THAT THE ABDOMINAL AORTIC ANEURYSM WAS 95MM. NO ANEURYSM RUPTURE WAS NOTED. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, IMAGES WERE VIEWED ON HOSPITAL SOFTWARE AND THERE WAS NO DISC AVAILABLE FOR PLANNING OR 3D RECONSTRUCTION. IT WAS REPORTED THAT WHEN THE PHYSICIAN DID THE CONTRAST RUN TO MEASURE THE LENGTH, HE BELIEVED THE RIIA WAS COMING OFF EXACTLY WHERE THE LARGE SHEATH WAS. THE PHYSICIAN ASKED GORE FIELD SALES ASSOCIATE (FSA) TO MARK THE SCREEN AT THAT ZONE AND UPON DEPLOYMENT AND RUN, REALIZED IT MUST HAVE BEEN COMING OFF HIGHER AND THE OSTIUM WAS HIDDEN BY THE RCIA. IN HINDSIGHT THE PHYSICIAN REALIZED HE SHOULD HAVE ANGLED THE C-ARM FURTHER TO GET A BETTER IMAGE OF THE RIIA OSTIUM. UNFORTUNATELY, BECAUSE IT WAS URGENT, AND THEY DIDN'T HAVE ACCESS TO THE IMAGES AND WERE UNABLE TO GET ACCURATE ANGLES OF THE RIIA OSTIUM. UPON DOING A POST CONTRAST RUN, THE PHYSICIAN REALIZED THAT THE RIIA WAS COVERED. THE AAA WAS SEALED, RIGHT INTERNAL ILIAC ARTERY HAS BEEN E

  Patient problems: Aneurysm; Aneurysm expansion; Foreign Body Embolism

  MAUDE report 21669724 ↗
• InjuryFeb 18, 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) 2025, THE PHYSICIAN NOTIFIED FIELD SALES ASSOCAITE (FSA) ABOUT A PATIENT IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3) APPROXIMATELY 3-4 YEARS AGO. REPORTEDLY, THE ANEURYSM HAS GROWN BY ABOUT 2CM IN THAT TIME AND IS NOW IN THE 7CM RANGE. PATIENT HAS HAD MULTIPLE ANGIOGRAMS AND NEITHER THEY NOR THE CTA¿S SHOW EVIDENCE OF TYPE 1 OR TYPE 2 ENDOLEAKS. PHYSICIAN SUSPECTS THAT IT IS A TRANSGRAFT TYPE PHENOMENON. IT IS ALSO WORTH NOTING THAT THIS PATIENT IS ON ELOQUIST FOR AFIB. HE IS GETTING A WATCHMAN PROCEDURE IN THE NEAR FUTURE WITH THE HOPE THAT THEY CAN DISCONTINUE THE ELOQUIST AS PHYSICIAN SUSPECTS THAT COULD BE A FACTOR, AND HOPEFUL THAT THAT MIGHT ELIMINATE THE SAC ENLARGEMENT. 1001-E:-UNKNOWN IS USED TO CAPTURED THE GROWTH OF ANEURYSM WITHOUT ENDOLEAK,

  Patient problems: Aneurysm expansion

  MAUDE report 21404113 ↗
• DeathJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT EXPIRED. IT WAS REPORTED THE FIELD SALES ASSOCIATE (FSA) CONTACTED THE PHYSICIAN AND WAS TOLD THE PATIENT HAD A PREVIOUSLY IMPLANTED ENDOLOGIX ALTO DEVICE IMPLANTED. IMAGES (DATE AND MODALITY IS NOT AVAILABLE) REVEALED A TYPE I A ENDOLEAK. THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND COAGULOPATHY. DURING PROCEDURE THE PATIENT HAD BLOOD LOSS OF 20,000CC, BLOOD PRODUCTS WERE GIVEN. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSE OF DEATH TO THE IMPLANTED GORE DEVICES. FSA WAS NOT PRESENT FOR THIS PROCEDURE AND WAS NOT AWARE THAT GORE DEVICES WERE IMPLANTED NOR WAS HE AWARE THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Coagulation Disorder

  MAUDE report 18591781 ↗
• MalfunctionNov 2, 2023Difficult to Flush; Fracture; Leak/Splash; Difficult to Flush; Fracture; Leak/Splash

  ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING THREE GORE® AAA ENDOPROSTHESES (ONE MAIN TRUNK AND TWO CONTRALATERAL LEG ENDOPROSTHESES) FOR TREATMENT. DURING THE PROCEDURE, AFTER FULL DEPLOYMENT OF THE MAIN TRUNK (RLT311413) AND ONE PLC DEVICE (PLC231200), THE OPERATOR TRIED TO FLUSH THE CONTRALATERAL LEG (PLC201400) ON THE PREP TABLE. AFTER REMOVING THE PROTECTIVE TRANSPORTING WIRE FROM THE OLIVE OF THE PLC201400, HE FLUSHED THE FLUSHING PORT PROPERLY, BUT THE LIQUID WAS NOT COMING FROM THE OLIVE, BUT INSTEAD FROM THE CONNECTION POINT OF THE ENDOPROSTHESIS AND CATHETER (AT THE BEGINNING OF STENT GRAFT ITSELF). THE OPERATOR TRIED TO INSERT THE LUNDERQUIST STIFF GUIDEWIRE THROUGH THE OLIVE, BUT RESISTANCE WAS FELT APPROX. AFTER 14 CM OF INSERTION. AFTER FEW TRIES, ADVANCEMENT AND IMPLANTATION OF THE DEVICE WAS SUCCESSFUL. UPON PULLING THE CATHETER OUT, BREAKAGE AT THE SPOT WHERE BLOCKAGE OCCURRED WAS NOTICED. THE PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE. THE NAMED CATHETER WILL BE SHIPPED BACK TO GORE FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053834 ↗
• InjuryMar 21, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2017, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESES, AND THREE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK AND A TYPE IB ENDOLEAK. THE TYPE IA WAS TREATED WITH ANOTHER MANUFACTURERS DEVICE, AND THE TYPE IB WAS TREATED WITH TWO EXCLUDER LIMBS. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THE ENDOLEAKS WERE CAUSED BY MIGRATION AND ANEURYSM ENLARGEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16582708 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION WHEREBY GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) WERE USED TO EXTEND THE 20MM CONTRALATERAL LEG COMPONENT, LOCATED ON THE PATIENT'S LEFT SIDE. REPORTEDLY, THERE WAS NO OBSERVED ISSUE WITH THE CONTRALATERAL LEG COMPONENT, AND NO OBSERVED DISTAL TYPE I ENDOLEAK. THE ANEURYSM SAC HAD REPORTEDLY GROWN FROM 3CM TO 12CM IN 8 MONTHS, AND THE PHYSICIAN WANTED TO REINFORCE THE LEFT LIMB IN CASE A CONVERSION WAS REQUIRED AT A LATER DATE DUE TO SAC GROWTH. IT WAS ALSO OBSERVED THAT THE CONTRALATERAL LEG COMPONENT DID NOT EXTEND ALL THE WAY DOWN TO THE PATIENT'S LEFT INTERNAL ILIAC ARTERY, AND THEREFORE THE PHYSICIAN OPTED TO IMPLANT THE IBE DEVICES. THERE WAS REPORTEDLY NO VISIBLE CAUSE FOR THE ANEURYSM GROWTH. THE PATIENT TOLERATED THE REINTERVENTION. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Aneurysm expansion

  MAUDE report 16486908 ↗
• 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 15351093 ↗
• InjuryAug 18, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT WAS TREATED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, CT IMAGING SHOWED A RIGHT SIDED TYPE 1B ENDOLEAK. A REINTERVENTION IS BEING PLANNED TO EXTEND THE RIGHT LIMB TO TREAT THE ENDOLEAK. SEVERAL CONTRALATERAL LIMBS WERE INCLUDED IN THE REPORT BUT IT IS NOT KNOWN WHICH WAS ADJACENT TO THE ENDOLEAK. ALL OTHER CONTRALATERAL LIMBS ARE LISTED IN ADDITIONAL MANUFACTURING NARRATIVE.

  Patient problems: Aneurysm

  MAUDE report 15254817 ↗
• InjuryJul 18, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, IT WAS REPORTED TO GORE THAT A PATIENT WITH A PARTIALLY THROMBOSED INFRARENAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 6.9 X 8.2 CM WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT 281414, WITH THE IPSILATERAL LEG ON THE RIGHT). THIS RIGHT SIDE WAS THEN LENGTHENED WITH ANOTHER GRAFT (PLC 201400, SN (B)(4)). A THIRD GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED ON THE CONTRALATERAL (LEFT) SIDE (PLC 201400, SN (B)(4)). BOTH THE MAIN BODY WITH LENGTHENING AND THE CONTRALATERAL LEG ARE DILATED WITH A 33 MM DIAMETER BALLOON (EQUALIZER BALLOON CATHETER, BOSTON SCIENTIFIC). THE SUBSEQUENT ANGIOGRAPHY SHOWS THAT THE PROSTHESIS IS PROPERLY SEATED. THE INFRARENAL ABDOMINAL AORTIC ANEURYSM COULD BE ELIMINATED. NO EVIDENCE OF AN ENDOLEAK. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT UNDERWENT EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY, WITH AN EXTENSION OF THE LEFT LEG UNTIL THE EXTERNAL ILIAC ARTERY ON (B)(6) 2022 USING AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT CONTRALATERAL LEG). THE REASON FOR THE REINTERVENTION IS A TYPE 1B ENDOLEAK WITH CONNECTING ANEURYSM DISTAL TO THE IMPLANT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 15040782 ↗
• MalfunctionJun 22, 2022Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON JUNE 4TH, 2022, THE PATIENT WAS ADMITTED FOR EMERGENT TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. AS REPORTED, THE RUPTURE OCCURRED ON THE LEFT SIDE OF THE PATIENT ABOVE THE HYPOGASTRIC. AS REPORTED, THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A NON-GORE DEVICE (MEDTRONIC) AND HAD VERY TORTUROUS ANATOMY. BOTH LIMBS WERE RELINED SUCCESSFULLY DURING THE PROCEDURE. AS REPORTED, POST-DEPLOYMENT, THE CATHETER OLIVE TIP AND THE "RAILING" DISCONNECTED FROM THE CATHETER AND BECAME DISLODGED IN THE COMMON ILIAC. THE ENTIRE CATHETER INCLUDING THE DISCONNECTED OLIVE TIP AND RAILING WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO SERIOUS INJURY TO THE PATIENT. THE CATHETER IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776559 ↗
• InjuryMay 13, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS USED TO TREAT A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM. THE SURGEON ACCIDENTALLY COVERED THE LEFT COMMON ILIAC ARTERY WITH THE STENT (PLC201400). IT WAS REPORTED THAT THE SURGEON DID NOT TRY TO CORRECT THE COVERAGE. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 14392191 ↗
• InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INTRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE TRUNK-IPSILATERAL LEG HAD BEEN DEPLOYED TO THE CONTRALATERAL GATE, WHICH WAS THEN CANNULATED, AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS DEPLOYED. AFTER THE DELIVERY CATHETER OF THE CONTRALATERAL LEG WAS WITHDRAWN, THE PHYSICIAN REMARKED ON A VISIBLE DENSITY AT THE TIP OF THE SHEATH, WHICH REMAINED IN THE PATIENT. THERE HAD BEEN NO DIFFICULTY REMOVING THE DELIVERY SYSTEM. IT WAS DETERMINED THAT THE LEADING OLIVE FROM THE DELIVERY CATHETER WAS ON THE GUIDEWIRE AND AT THE TIP OF THE 12FRENCH DRYSEAL SHEATH. THE PHYSICIAN WAS ABLE TO MANIPULATE THE OLIVE DOWN THE SHEATH BUT WAS CONCERNED ABOUT PULLING IT COMPLETELY OUT AND POTENTIALLY LOSING WIRE ACCESS. HE DECIDED TO DO A CUTDOWN ON THE FEMORAL ARTERY TO RETRIEVE THE OLIVE. THIS WAS DONE SUCCESSFULLY WITH NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Perforation

  MAUDE report 12440527 ↗
• InjuryMay 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION AFTER A RIGHT COMMON ILIAC ARTERY ANEURYSM ENLARGED DUE TO A TYPE IB ENDOLEAK, WHICH IN TURN CAUSED ONE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES TO PULL BACK INTO THE SAC OF THE PREVIOUSLY TREATED ABDOMINAL AORTIC ANEURYSM. ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO EXTEND FROM THE PREVIOUSLY IMPLANTED GRAFTS INTO THE EXTERNAL ILIAC. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11820990 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. POST-OP, THE PATIENT DEVELOPED BACK PAIN. A CT AND CTA WERE OBTAINED, WHICH WERE SUSPICIOUS FOR EXTRAVASATION. REVIEW OF EARLIER FILMS SHOWED SOME EXTRAVASATION AT THE DISTAL END OF THE LEFT LIMB, (PLC201400). IT WAS FELT THAT THIS LIKELY OCCURRED DURING BALLOONING WITH A MOB37 BALLOON. THE PATIENT WAS BROUGHT BACK ON THE SAME DAY FOR SUCCESSFUL EXTENSION OF THE LEFT LIMB USING ANOTHER PLC201400. FINAL ANGIOGRAM SHOWED A WELL PLACED DEVICE WITH NO EVIDENCE OF ENDOLEAK OR EXTRAVASATION. THE FINAL ANGIOGRAM DURING THE INDEX PROCEDURE WAS SUBOPTIMAL DUE TO THE PHYSICIAN TRYING TO LIMIT CONTRAST AND THEY DID NOT RECOGNIZE THE SMALL EXTRAVASATION AT THAT TIME. THE CT SCAN SHOWED WHAT APPEARED TO BE BLOOD COLLECTED IN THE PELVIS BUT NO ACTIVE BLEEDING WAS SEEN AT THE TIME OF THE SCAN. THE INDEX PROCEDURE FILMS WERE REVIEWED AGAIN AND THE SMALL EXTRAVASATION WAS FOUND AT THE DISTAL END OF THE LEFT LIMB. IT WAS FELT THE BLEEDING PROBABLY STARTED AFTER BALLOONING THE LIMB AND THEN STOPPED BY THE TIME THE CT WAS OBTAINED. THE

  Patient problems: Extravasation; Pain

  MAUDE report 11634529 ↗
• InjurySep 25, 2020Migration; Migration

  ON SEPTEMBER 4, 2020, FOLLOW-UP IMAGES WERE PROVIDED TO THE FIELD SALES ASSOCIATE. THE PHYSICIAN REPORTS THAT THE CONTRALATERAL LIMB SEEMS TO BE SITTING UP A LITTLE HIGH AND MAY HAVE MIGRATED PROXIMALLY. NO OTHER ISSUES WERE REPORTED. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND THE CONTRALATERAL SIDE WAS IMPLANTED WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT TO PROVIDE ADDITIONAL COVERAGE TO THE COMMON ILIAC ARTERY DUE TO PROXIMAL MIGRATION OF INITIAL GRAFT UP WITHIN THE ANEURYSM SAC. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 10590787 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT REPORTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A TYPE II ENDOLEAK. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS USED TO RESOLVE THE ENDOLEAK. THE REINTERVENTION WAS DONE DUE TO THE RISK OF SERIOUS INJURY CAUSED BY THE PREVIOUS RUPTURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10483714 ↗
• InjurySep 2, 2020Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, FOLLOW UP REVEALED A DISTAL TYPE I ENDOLEAK DUE TO ONE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES MIGRATING PROXIMALLY. THE PHYSICIAN BELIEVES THIS IS DUE TO DISEASE PROGRESSION, AS THE DEVICE IMPLANTED WAS 20MM IN DIAMETER, AND THE LEFT COMMON ILIAC IS NOW 25-28MM IN DIAMETER. A REINTERVENTION IS PLANNED. FURTHER INFORMATION FROM THE FSA REPORTED THAT THE PLANNED REINTERVENTION TOOK PLACE ON (B)(6) 2020. AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED, AND THE PHYSICIAN REINFORCED IT WITH A PALMAZ STENT. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10483013 ↗
• InjuryApr 17, 2020Partial Blockage; Partial Blockage

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLC201400 WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT REPORTED A COLD RIGHT LEG. IT WAS REPORTED THAT THROMBUS WAS PRESENT IN THE PLC201400. A GORE® EXCLUDER® AAA ENDOPROSTHESIS PLL161207 WAS IMPLANTED AND BALLOONED, WHICH RESOLVED THE ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 9973108 ↗
• InjuryApr 1, 2020Partial Blockage; Partial Blockage

  ON (B)(6) 2018 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 IMAGES WERE PROVIDED TO GORE. THE CT IMAGING DATE WAS (B)(6) 2020. IT WAS REPORTED THAT THERE APPEARED TO BE THROMBUS LAYERS ACROSS BOTH THE IPSILATERAL AND CONTRALATERAL LEG COMPONENTS, WITH POSSIBLE OCCLUSION THROUGH BOTH LIMBS AT THE LEVEL OF DEVICE OVERLAP/LIMB CROSSING. A POSSIBLE TYPE III OR TYPE II ENDOLEAK WAS ALSO REPORTED. EVALUATION OF THE IMAGES LATER REVEALED THAT THERE WAS NO EVIDENCE OF THROMBUS WITHIN THE LIMBS AT THE LEVEL OF THE CONTRALATERAL GATE. THE SUSPECTED CAUSE OF THE REPORTED THROMBUS WAS REPORTEDLY UNKNOWN. A REINTERVENTION WAS PERFORMED ON (B)(6) 2020. THE TYPE OF ENDOLEAK WAS UNABLE TO BE DETERMINED. TWO CONTRALATERAL LEG COMPONENTS WERE USED TO RELINE THE IPSILATERAL AND CONTRALATERAL LIMBS OF THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA SYSTEM. IT WAS NOTED THAT THE RELINING DID NOT EXTEND PAST THE PREVIOUSLY IMPLANTED DEVICES DISTALLY. IT WAS REPORTED THAT, ON FINAL ANGIOGRAPHY, NO ENDOLEAK WAS NOTED ON THE DEVICES, BUT CONTRAST WAS NOTED IN THE LUMBAR ARTERIES. THE SUSPECTED TYPE II ENDOLEAK WILL CONTIN

  Patient problems: Occlusion; Thrombus

  MAUDE report 9911353 ↗
• InjuryMar 27, 2020Adverse 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 USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, BILATERAL TYPE IB ENDOLEAKS WERE DISCOVERED. THE ENDOLEAKS WERE CAUSED BY BILATERAL DEGENERATIVE ILIAC DISEASE. ON (B)(6) 2020, A REINTERVENTION OCCURRED TO TREAT THE ENDOLEAKS. ON THE LEFT SIDE, COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED ALONG WITH AN IMPLANT OF A CONTRALATERAL LEG COMPONENT TO EXTEND DISTALLY TO THE LEFT EXTERNAL ILIAC ARTERY. ON THE RIGHT SIDE, A RETROGRADE IMPLANT OF AN IBE DEVICE WAS PERFORMED (OFF LABEL) TO EXTEND AND BRIDGE THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT.

  Patient problems: Aneurysm

  MAUDE report 9889324 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, A TYPE I DISTAL ENDOLEAK FROM THE RIGHT LIMB COMPONENT WAS DISCOVERED ON FOLLOW UP COMPUTED TOMOGRAPHY. ON THE SAME DAY, A REINTERVENTION OCCURRED WHEREBY THE RIGHT ILIAC COMPONENT (PLC201400/20353603) WAS EXTENDED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENTS. THE ENDOLEAK WAS RESOLVED. NO ANEURYSM ENLARGEMENT WAS IDENTIFIED. THE CAUSE OF THE ENDOLEAK WAS ATTRIBUTED BY A HIGHLY ANGULATED ILIAC ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363051 ↗

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