GORE EXCLUDER AAA Endoprosthesis PLC161000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132618668), received between May 5, 2016 and May 15, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT INTERNAL ILIAC ARTERY WAS PARTIALLY COVERED. THIS WAS UNPLANNED, THE PATIENT HAD ¿SHORT¿ ANATOMY. THERE WAS PARTIAL FLOW AT THE END OF THE PROCEDURE. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25185013 ↗
• InjuryMar 2, 2026Migration

  ON (B)(6) 2015, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN IMAGING WHICH SHOWED ANEURYSMAL DILATATION DISTAL TO THE ORIGINALLY IMPLANTED LIMBS ON BOTH SIDES. IT IS UNKNOWN IF THE LIMBS MIGRATED PROXIMALLY FROM THE ORIGINAL PLACEMENT, HOWEVER THE RIGHT LIMB IS CURRENTLY 21 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY AND THE LEFT LIMB IS 45 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY. ON (B)(6) 2025, THE PATIENT WAS BROUGHT IN FOR RE-INTERVENTION AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE DEVICES WERE IMPLANTED ON BOTH SIDES. A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS ALSO IMPLANTED ON THE LEFT SIDE LEFT SIDE PRIOR TO IBE PLACEMENT TO EXTEND THE PRIOR LIMB AND CREATE A LANDING ZONE. THIS SUCCESSFULLY EXCLUDED THE COMMON ILIAC ANEURYSMS. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Aneurysm

  MAUDE report 24484138 ↗
• InjuryFeb 4, 2026Malposition of Device

  THE 30 DAY CT SCAN SHOWED THAT THE DEVICE MOVED UPWARD AND WAS NO LONGER COVERING THE HYPOGASTRIC ARTERY, RESULTING IN RESTORED BLOOD FLOW. THE DISTANCE THE DEVICE MAY HAVE MIGRATED IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24259104 ↗
• InjuryDec 19, 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, A PATIENT WAS TREATED FOR AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), INCLUDING 3 GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICES (PLC). REPORTEDLY, THE PHYSICIAN HAD PREVIOUSLY TRIED OPEN REPAIR AND WAS REINTERVENING BECAUSE THE AORTA WAS REJECTING THE OPEN REPAIR. ON (B)(6) 2025, A REINTERVENTION TOOK PLACE. A DEGENERATIVE THROMBUS HAD DEVELOPED JUST DISTAL TO THE RIGHT-SIDE PLC. A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE WAS USED TO EXTEND INTO THE RIGHT EXTERNAL ILIAC, COVERING AND COILING THE RIGHT INTERNAL ILIAC ARTERY, AND COVERING THE DEGENERATIVE THROMBUS. IMAGES ARE AVAILABLE. REPORTEDLY, THE PHYSICIAN ATTRIBUTES THE THROMBUS TO THE INTERACTION BETWEEN THE DEVICES AND THE PATIENT'S CONNECTIVE TISSUE DISORDER.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23857850 ↗
• InjuryNov 18, 2025Complete Blockage; Use of Device Problem; Obstruction of Flow; Complete Blockage; Use of Device Problem; Obstruction of Flow

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. REPORTEDLY, THE MAIN BODY WAS DEPLOYED WITH NO ISSUES. THE CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE. IT WAS REPORTED THAT THE PHYSICIAN MEASURED THE LIMB FOR THE RIGHT-SIDE EXTENSION AND USED A PLC161000/ (B)(6) DEVICE WITHOUT CONFIRMATION OF MARKERS. AFTER THE DEVICE DEPLOYMENT, THE PHYSICIAN REALIZED THAT HE HAD MIS-INTERPRETED THE MARKERS ON THE DEVICE AND STATED THAT HE HAD ACCIDENTALLY COVERED THE PATIENT¿S RIGHT INTERNAL ILIAC ARTERY. SEVERAL ATTEMPTS WERE MADE TO PUSH THE LIMB UPWARD, BUT THIS WAS UNSUCCESSFUL. THERE WAS SOME MILD FLOW STILL FILLING THE INTERNAL ILIAC ARTERY, HOWEVER THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE AND RE-SCAN AND PLAN TO RETURN ANOTHER TIME. REINTERVENTION IF REQUIRED/DECIDED. THE CAUSE OF EVENT WAS THAT THE PHYSICIAN RUSHED TO DEPLOY THE LIMB AND HAD AN UNCLEAR OVERLAY ON THE SCREEN WHICH THE PHYSICIAN STATED CONFUSED THE VIEW OF THE MARKERS ON THE GORE® EXCLUDER® AAA ENDOPROSTHESIS LIMB. THE PHYSICIAN DID NOT SEE THE MOST DISTAL MARKER AND DEPLOYED THE DEVICE WITHOUT DISCU

  Patient problems: Foreign Body Embolism; Ischemia

  MAUDE report 23578392 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING STENT WITHDRAWAL FROM THE ILIAC ARTERY, THE OLIVE TIP DETACHED FROM THE DELIVERY CATHETER¿LIKELY DUE TO INCREASED TRACTION APPLIED BY THE PHYSICIAN. THE COMPONENT REMAINED ON THE GUIDEWIRE AND WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PATIENT EXPERIENCED NO HARM AND TOLERATED THE PROCEDURE. THE OLIVE TIP DETACHING IN THE ILIAC WAS DUE TO THE PATIENT'S TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530195 ↗
• InjuryMay 22, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (EXCC) WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS. FOLLOWING DEPLOYMENT OF THE PLC161000 EXTENSION TO THE IPSILATERAL LIMB IN THE RIGHT COMMON ILIAC, IT WAS NOTICED THAT THE DEVICE WAS UNINTENTIONALLY COVERING THE RIGHT INTERNAL ILIAC ARTERY. THE ARTERY WAS RETROFILLING FROM THE LEFT INTERNAL ILIAC, SO THE PHYSICIAN DECIDED NO TREATMENT WAS NEEDED FOR THAT TIME. REPORTEDLY, THE DISTAL RADIOPAQUE MARKER WAS MISIDENTIFIED ON THE ANGIO.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22070149 ↗
• InjuryMay 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE, UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC181200 SN (B)(6) AND PLC161000 SN (B)(6) AND EXCLUDER CONFORMABLE (CXT281412 SN (B)(6), TO TREAT AND ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2025, A GRAFT INFECTION WAS OBSERVED. IT WAS ALSO REPORTED PATIENT HAS NO KNOWN HISTORY OF PREVIOUS INFECTIONS, AND IT IS UNKNOWN WHAT CAUSED THE INFECTION. IT ALSO UNKNOWN WHICH DEVICE HAS AN INFECTION. PATIENT WAS GIVEN ANTIBIOTICS AND IS AWAITING SURGICAL EXPLANT. IT WAS LATER REPORTED PATIENT WILL BE MOVING OUT OF STATE, AND WILL DECIDE LATER IF DEVICES WILL BE EXPLANTED. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21960512 ↗
• InjuryMay 1, 2025Patient-Device Incompatibility; Device Endoleak; Patient-Device Incompatibility; Device Endoleak

  ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED WHEREBY THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND A PLC121400 GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS USED TO EXTEND INTO THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Clinical Endoleak

  MAUDE report 21944320 ↗
• InjuryJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS, AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, FSA WAS NOTIFIED THAT PATIENT SUFFERED FROM PARAPARESIS. ONSET DATE OF PARAPARESIS WAS REPORTED TO BE (B)(6) 2024. IT WAS ALSO REPORTED THE PATIENT UNDERWENT A CSF DRAIN ON (B)(6) 2024, HOWEVER PATIENT STILL SUFFERS FROM PARAPARESIS. NO ADDITIONAL TREATMENT IS CURRENTLY BEING PLANNED FOR THE PATIENT. THE CAUSE OF THIS PARAPARESIS IS ALLEGEDLY DUE TO IT BEING A LARGE TREATMENT AREA. PATIENT HAD A TERUMO GRAFT PLACED FIRST (32MM X 10CM) TO PROVIDE PROXIMAL SEAL FOR THE TAMBE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Paraplegia

  MAUDE report 21263825 ↗
• InjuryJan 15, 2025Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IN ZONE 9. IT WAS REPORTED THAT WHEN THEY PUT THE DEVICE IN, THE LENGTH WAS TOO LONG AND THEY WERE GOING TO HAVE TO SACRIFICE THE INTERNAL ILIAC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163980 ↗
• InjuryDec 13, 2024Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC AND COMMON ILIAC ANEURYSM UTILIZING MULTIPLE GORE DEVICES ALONG WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE). REPORTEDLY, PHYSICIAN HAD DIFFICULTY TRACKING THE INTERNAL ILIAC COMPONENT TO THE INTENDED LOCATION DUE TO PATIENT'S VERY LONG AND TORTUOUS ANATOMY. PHYSICIAN REMOVED THE DEVICE. PHYSICIAN DID NOT PLAN ON COILING THE INTERNAL ILIAC ARTERY AS WIRES WERE IN PLACE BUT COULD NOT TRACK THE DEVICE. PHYSICIAN DID A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY THEN EXTENDED ALL THE WAY TO THE EXTERNAL ILIAC ARTERY FROM THE FLOW DIVIDER OF THE TRUNK IPSILATERAL LEG WITH A BRIDGING LIMB (CONTRALATERAL LEG) TO THE IBE FLOW DIVIDER AND PAST IT DUE TO ADDITIONAL LENGTH THAT WAS NEEDED. PROCEDURE ENDED SUCCESSFULLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20929389 ↗
• MalfunctionMar 6, 2023Material Separation; Material Separation

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THERE WAS AN ESTIMATED 90 DEGREE BEND IN THE PATIENT'S LEFT COMMON ILIAC ARTERY, AND THE AREA WAS HIGHLY CALCIFIED. IT WAS REPORTED THAT A CONTRALATERAL LEG COMPONENT WAS ADVANCED AND DEPLOYED ON THE PATIENT'S LEFT SIDE WITH NO ISSUES. REPORTEDLY, THE DELIVERY CATHETER WAS SUCCESSFULLY REMOVED AND THE PHYSICIAN OPTED TO EXTEND WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THAT THE INTRODUCER SHEATH WAS ADVANCED WITH NO ISSUES. IT WAS NOTED THAT BALLOONING MAY HAVE BEEN NECESSARY DUE TO THE ARTERY BEING POTENTIALLY STENOTIC. HOWEVER, THERE WERE NO REPORTED ISSUES WITH DEVICE ADVANCEMENT, DELIVERY, OR DEPLOYMENT. IT WAS REPORTED THAT THERE WAS DIFFICULTY MANAGING THE LEFT ACCESS SITE DUE TO PLAQUE AND BLEEDING IN THE CUTDOWN AREA. IT WAS NOTED THAT, AFTER SUCCESSFUL DEPLOYMENT OF THE SECONDARY CONTRALATERAL LEG COMPONENT, THE PHYSICIAN REMOVED THE DELIVERY CATHETER QUICKLY IN AN ATTEMPT TO FINISH THE CASE AND MAINTAIN THE LEFT SIDE. AFTER REMOVAL OF THE DELIVERY CATHETER, IT WAS OBSERVED THAT THE LEADI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486243 ↗
• MalfunctionNov 21, 2022Entrapment of Device; Detachment of Device or Device Component; Physical Resistance/Sticking

  ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ANEURYSM RUPTURE AND GRAFT REPAIR OF A NON-GORE GRAFT. AS REPORTED, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AS REPORTED, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS FULLY DEPLOYED. AS REPORTED, DURING CATHETER WITHDRAWAL SOME RESISTANCE WAS FELT. AS REPORTED, THE LEADING OLIVE TIP HAD DETACHED FROM THE CATHETER. AS REPORTED, AN ATTEMPT WAS MADE TO ADVANCE THE SHEATH FOR RETRIEVAL OF THE OLIVE TIP, BUT THIS WAS NOT SUCCESSFUL. AS REPORTED, THE OLIVE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. AS REPORTED, THERE WAS A TIGHT BEND IN THE ILIAC ARTERY WHERE THE OLIVE DETACHED. THE CATHETER AND OLIVE WERE SAVED FOR RETURN TO GORE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840757 ↗
• MalfunctionDec 28, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  ON (B)(6) 2003 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH A GORE® EXCLUDER® BIFURCATED ENDOPROSTHESES (PCC121200 AND PCT261216). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021 THE PATIENT WAS UNDERGOING TREATMENT FOR A TYPE 1B ENDOLEAK WITH AN UNKNOWN ONSET DATE. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG ENDOPROSTHESIS (PLC161000) WAS INSERTED INTO THE PATIENT AND WAS POSITIONED IN THE PATIENTS ANATOMY FOR DEPLOYMENT. AS REPORTED THE DEPLOYMENT LINE WOULD NOT PULL AND FELT LIKE IT WAS STUCK, AND THE ENDOPROSTHESIS WOULD NOT DEPLOY. THE DEVICE WAS REMOVED OVER THE GUIDEWIRE AND A NEW CONTRALATERAL ENDOPROSTHESIS DEVICE WAS INSERTED AND EMPLOYED WITHOUT INCIDENT. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097455 ↗
• InjuryJun 1, 2021Device Damaged by Another Device; Patient Device Interaction Problem; Device Damaged by Another Device; Patient Device Interaction Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC & BILATERAL COMMON ILIAC ARTERY ANEURYSMS USING GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES AND GORE¿ EXCLUDER¿ ILIAC BRANCH ENDOPROSTHESES. THE PROCEDURE WAS REPORTEDLY COMPLETED SUCCESSFULLY, WITH NO APPARENT COMPLICATIONS. THE PATIENT'S ANATOMY WAS NOT REPORTED AS TORTUOUS OR CALCIFIED. ON OR ABOUT (B)(6) 2021 THE PATIENT REPORTEDLY HAD A FOLLOW-UP APPOINTMENT WITH THE PHYSICIAN. THE PATIENT REPORTED FEELING GOOD, BUT DID NOTE SOME LEG CRAMPING. ON (B)(6) 2021 FOLLOW-UP CTA IDENTIFIED THAT THE TRUNK OF THE TRUNK-IPSILATERAL LEG COMPONENT HAD COLLAPSED. DISTAL BLOOD FLOW WAS NOTED BILATERALLY DESPITE THE DEVICE COLLAPSE. THE PHYSICIAN DID NOT REPORT A SUSPECTED CAUSE FOR THE DEVICE COLLAPSE. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED. SIGNIFICANT THROMBUS ACCUMULATION WAS REPORTED THROUGH THE IMPLANTED CONTRALATERAL LEG COMPONENTS BILATERALLY, AS WELL AS THROUGH THE GORE¿ EXCLUDER¿ ILIAC BRANCH COMPONENTS. THE GORE¿ EXCLUDER¿ INTERNAL ILIAC COMPONENT LOCATED IN THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS REPORTEDLY PARTIALLY OCCLUDED. IT WAS NOTED THAT THE GORE¿ VIABAHN¿ VBX BALLOON EXPANDABLE ENDOPROSTHE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11914161 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ENLARGING ANEURYSMAL LEFT COMMON ILIAC ARTERY (LCIA) JUST DISTAL TO THE CONTRALATERAL LEG COMPONENT ORIGINALLY PLACED. THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS PLACED TO EXTEND COVERAGE AND OBTAIN GOOD SEAL JUST PRIOR TO THE ORIGIN OF THE LEFT HYPOGASTRIC ARTERY. GOOD DISTAL SEAL WAS ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. THE PHYSICIAN ATTRIBUTED THE ENLARGEMENT OF THE LCIA TO DISEASE PROGRESSION.

  Patient problems: Aneurysm

  MAUDE report 10144571 ↗
• InjuryMay 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS RECORDED IN THE MEDICAL DEVICE TRACKING SYSTEM THAT THE GORE® EXCLUDER® AAA ENDOPROSTHESES CONTRALATERAL LEG COMPONENT WAS EXPLANTED AND DESTROYED ON THE DAY OF IMPLANT. THE REASON FOR EXPLANT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10066686 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL, COMMON ILIAC RIGHT AND LEFT AORTIC ANEURYSMS MEASURING 48MM ¿ABDOMINAL, 26MM- RIGHT ILIAC AND 34.3MM- LEFT ILIAC WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, DURING THE INITIAL PROCEDURE THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE PATIENT UNDERWENT THE LEFT INTERNAL ILIAC ARTERY EMBOLIZATION. THE FOLLOW UP IMAGES FROM (B)(6) 2016 TO (B)(6) 2018 REVELED THAT THE ANEURYSM ENLARGED IN DIAMETER FROM 38MM TO 39MM.

  Patient problems: Aneurysm

  MAUDE report 8329577 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2015 THE ANEURYSM MEASURING 69MM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED. ON (B)(6) 2015 THE ANEURYSM MEASURED 68MM. ON (B)(6) 2016 THE ANEURYSM MEASURED 69MM. ON (B)(6) 2016 THE ANEURYSM MEASURED 70MM. ON (B)(6) 2017 THE ANEURYSM MEASURED 71MM. ON (B)(6) 2019 A REINTERVENTION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK WHEREBY ONYX EMBOLIZATION OF THE AAA SAC WAS PERFORMED. A TYPE IB ENDOLEAK WAS TREATED WITH DISTAL EXTENSION ON THE RIGHT SIDE. ADDITIONALLY, A LEFT FEMORAL ENDARTERECTOMY AND PATCH ANGIOPLASTY WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 8302960 ↗
• InjuryMay 5, 2016Break; Activation, Positioning or Separation Problem

  AFTER GRAFT WAS DEPLOYED IT WAS NOTED THAT A PIECE OF THE DELIVERY DEVICE HAD BROKEN OFF INSIDE THE ARTERY. BROKEN PIECE WAS IMMEDIATELY RETRIEVED BY SURGEON.

  Patient problems: No Information

  MAUDE report 5640760 ↗

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)