GORE EXCLUDER AAA Endoprosthesis PLC231200Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00733132618569), received between Sep 28, 2018 and Aug 7, 2026 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, this patient underwent endovascular treatment for an Aortoiliac aneurysm (AAA) and was implanted with GORE® EXCLUDER® Conformable AAA ENDOPROSTHESIS devices. Additionally, during the index procedure the patient¿s right common iliac artery was coil embolized. Pre-procedure computed tomography angiography (CTA) performed on (b)(6) 2026, determined the maximum diameter of the abdominal aorta measured 59mm, with a maximum diameter proximal landing zone of 24mm. The maximum diameter of the right common iliac artery (RCIA) measured 37.7mm and the maximum diameter of the left common iliac artery (LCIA) measured 32mm. Successful access, delivery, and accurate deployment of the devices to their intended location, and retrieval of the delivery system was reported. There were no corrective procedure(s) or complications related to the device, procedure, or withdrawal of the delivery system. The patient tolerated the procedure and was discharged to home (self-care) on (b)(6) 2026. On (b)(4), 2026, the patient experienced ongoing buttock claudication related to the treatment/procedure.On an unknown date in (b)(6) 2026, a type II Endo leak was determined and reported to be due to

  Patient problems: Reduced Blood Flow

  MAUDE report 50168745 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ALLEGEDLY, ON (B)(6) 2026, DURING A CT SCAN, AN ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN) WAS OBSERVED DISTALLY. NO ENDOLEAK OR OTHER ISSUES WERE NOTED. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH A PLC231000 DEVICE WAS IMPLANTED DISTAL TO AN EXISTING CONTRALATERAL LIMB ON THE RIGHT SIDE, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 25271572 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT SHOWED UP AT SEATTLE VA AND WAS SEEN BY A PHYSICIAN WHO DETERMINED THE ANEURYSM SACK AND THE GRAFTS ARE INFECTED. THE PHYSICIAN PLANS TO EXPLANT THE DEVICES HOWEVER HOWEVER THIS PROCEDURE HAS NOT YET BEEN SCHEDULED, AS THE PATIENT WANTS TO WAIT.

  Patient problems: Medical device site infection

  MAUDE report 23785335 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WHILE BALLOONING (WITHIN THE DEVICE) THE RIGHT ILIAC ARTERY DEVICE, THE ARTERY DISSECTED. THE PHYSICIAN EXTENDED THE DEVICES IN THE EXTERNAL ILIAC ARTERY WITH TWO ADDITIONAL DEVICES AND USED A AMPLATZER PLUG TO BLOCK BLOOD FLOW INTO THE HYPOGASTRIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 23619100 ↗
• InjuryNov 13, 2025Migration; Device Endoleak; Migration; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A 10 CM SYMPTOMATIC ABDOMINAL ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC231200 AND PLC231000) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA260005). THE PLC231200 WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, THEN EXTENDED WITH THE PLC231000 FOR ADDITIONAL COVERAGE, AND THEN THE CXA260005 WAS IMPLANTED DISTAL TO THE PLC231000 AS ADDITIONAL COVERAGE. IN ADDITION TO THESE THREE DEVICES IN THE LEFT COMMON ILIAC ARTERY, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND TWO OTHER GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRALATERAL LEGS) IN THE RIGHT COMMON ILIAC ARTERY. ON THE FINAL ANGIOGRAM FOR THE INITIAL PROCEDURE, THERE WAS A TYPE 2 ENDOLEAK REPORTED WHICH THE PHYSICIAN PLANNED TO MONITOR. THIS TYPE 2 ENDOLEAK WAS CAUSED BY COLLATERALIZATION FEEDING THE ANEURYSM SAC. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THIS TYPE 2 ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION AS THE PLC231200, PLC231000, AND CXA260005 HAD MIGRATED PROXIMALLY AS ONE UNIT INTO THE LEFT COMMON ILIAC ARTERY, CAUSING A TYPE 1B ENDOLEAK.

  Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm

  MAUDE report 23547202 ↗
• InjuryJul 25, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE ON JULY 2, 2025 FROM THE IMEDIDATA STUDY DATABASE AND AN IMAGING REPORT: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM AT AN UNKNOWN FACILITY UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A REINTERVENTION DUE TO THE DEVELOPMENT OF A TYPE 1B ENDOLEAK ORIGINATING FROM THE LEFT COMMON ILIAC ARTERY ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (IBC) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE NO ADDITIONAL CORRECTIVE PROCEDURES. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A CT PERFORMED. IT IS NOTED BY IMAGING THAT THROMBUS WAS PRESENT WITHIN THE PROXIMAL END OF THE TRUNK-IPSI AND THE IBC. THERE WAS NO LOSS OF PATENCY NOTED.

  Patient problems: Clinical Endoleak

  MAUDE report 22610960 ↗
• InjuryJun 25, 2025Adverse 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) 2016, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, AND A LEFT ILIAC AORTIC ANEURYSM TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. IT WAS REPORTED THAT FOLLOW UP IMAGES DATED (B)(6) 2025, REVEALED THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (LEFT SIDE) HAD BECOME THROMBOSED AND NO LONGER PATENT. THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO INTERVENTION ON THE THROMBOSED DEVICE. THE RIGHT SIDE HAD DISEASE PROGRESSION (PLC201000/(B)(6) AND WAS ANEURYSMAL. THE PHYSICIAN CHOSE TO TREAT RIGHT SIDE DUE TO DISEASE PROGRESSION. A REINTERVENTION WAS PERFORMED AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® WAS IMPLANTED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm expansion

  MAUDE report 22332973 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS IN ZONE 9. IT WAS REPORTED THAT DURING THE FINAL ANGIOGRAM, A CLOT WAS IDENTIFIED IN THE RIGHT ILIAC ARTERY AT THE SITE WHERE THE CONTRALATERAL LEG WAS PLACED. THE PHYSICIAN PUT NEGATIVE ON A SHEATH TO EXTRACT THE CLOT. THE PHYSICIAN DOES NOT ATTRIBUTE THE CLOT TO THE DEVICE ITSELF, SUGGESTING INSTEAD THAT A FRAGMENT OF MURAL THROMBUS MAY HAVE DISLODGED DURING THE PROCEDURE. ADDITIONALLY, THERE WAS THROMBUS NOTED ON THE PRE-PROCEDURAL CTA USED FOR CASE PLANNING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22048761 ↗
• InjuryDec 12, 2024Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTING WITH AN BILATERAL COMMON ILIAC AND INTERNAL ILIAC ANEURYSMS WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS OUTSIDE OF INSTRUCTIONS FOR USE DUE TO THE USE OF GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICES IN THE INTERNAL ILIAC ARTERY AND A PROXIMAL LEFT COMMON ILIAC ARTERY DIAMETER OF 13 MM 17 MM IS REQUIRED. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. THE EMBOLIZATION WAS DIFFICULT AND TOOK 2 HOURS. THE MAIN ILIAC BRANCH COMPONENT (IBE) WAS DEPLOYED SUCCESSFULLY BUT THE PHYSICIAN WAS UNABLE TO ADVANCE THE 12 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH OVER AND INTO THE GATE. A SMALLER SHEATH WAS SUCCESSFULLY USED INSTEAD. THE LAST VBX WAS DEPLOYED AT THE GATE OF THE IBE JUST PROXIMAL TO THE LONG MARKER OF THE FLOW DIVIDER BECAUSE A 8LX79MM VBX SHORTENS SLIGHTLY WHEN POST-DILATED. THE TRUNK IPSILATERAL LEG WAS SUCCESSFULLY IMPLANTED BUT THE PHYSICIAN ENCOUNTERED PROBLEMS IN THE CONNECTION BETWEEN THE IBE AND THE TRUNK UPSILATERAL LEG. AFTER HAVING DEPLOYED A FEW CENTIMETERS IN THE GATE OF THE TRUNK IPSILATERAL LEG, THE PHYSICIAIN

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20917994 ↗
• InjuryDec 1, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2024, A SUCCESSFUL REINTERVENTION SURGERY WAS PERFORMED TO TREAT THE TYPE1B ENDOLEAK. A PLC161200 CONTRALATERAL COMPONENT WAS IMPLANTED. THE SUSPECTED TYPE 1A ENDOLEAK WAS NOT CONFIRMED. PHYSICIAN ELECTIVELY CHOSE TO IMPLANT AN AORTIC EXTENDER AT THE RENALS TO INCREASE PROXIMAL SEAL LENGTH. NO DEVICE ISSUE OR DEVICE MIGRATION WAS OBSERVED WITH RLT281414. PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 20814862 ↗
• InjuryFeb 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON JANUARY 4, 2024, THE GORE REPRESENTATIVE WAS INFORMED THAT THE PATIENT'S RIGHT COMMON ILIAC ARTERY HAD CONTINUED TO DILATE AND THE IMPLANTED CONTRALATERAL LEG COMPONENT ON THE PATIENT'S RIGHT SIDE APPEARED TO HAVE A DISTAL TYPE I ENDOLEAK. ON JANUARY 10, 2024, A REINTERVENTION WAS PERFORMED WHEREBY THE PHYSICIAN IMPLANTED A PLC271400 CONTRALATERAL LEG COMPONENT TO EXTEND THE RIGHT LIMB DISTALLY. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18635739 ↗
• InjuryOct 24, 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) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT POST PROCEDURE COMPUTED TOMOGRAPHY IMAGES (DATE UNKNOWN), A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON FOLLOW UP IMAGES. THE PHYSICIAN TOOK A WAIT AND WATCH APPROACH, REPORTEDLY THE PATIENT HAD A VERY ANGULATED NECK WHEN IMPLANTED. ON (B)(6) 2023, THE PHYSICIAN CHOSE TO EXPLANT (SURGICAL CONVERSION) THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES DUE TO A PERSISTENT PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM GROWTH (AMOUNT UNKNOWN). THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm expansion

  MAUDE report 17999790 ↗
• InjuryMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC DISSECTION AND A LEFT COMMON ILIAC ARTERY (LCIA) ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED THE LCIA HAD DILATED TO 26MM IN DIAMETER. ADDITIONALLY, A DISTAL TYPE I ENDOLEAK HAD DEVELOPED INVOLVING THE CONTRALATERAL LEG COMPONENT (PLC231200) ORIGINALLY IMPLANTED. ON (B)(6) 2023, THE PATIENT UNDERWENT RE-INTERVENTION AND AN ADDITIONAL IBE DEVICE WAS IMPLANTED WITHIN THE PLC231200 LIMB. THE LEFT INTERNAL AND IBE WERE CONNECTED USING A 11X59 MM VBX STENT. THE LEFT EXTERNAL WAS EXTENDED USING A PLC201000 LIMB SINCE THE EXTERNAL MEASURED 17.5 MM. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 16485628 ↗
• InjuryDec 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION FOR A TYPE III ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY. REPORTEDLY, THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT HAD SEPARATED FROM THE CONTRALATERAL LEG COMPONENT ON THE PATIENT'S LEFT SIDE. ANEURYSM ENLARGEMENT WAS ALSO OBSERVED (AMOUNT UNKNOWN). IT WAS NOTED THAT A GORE REPRESENTATIVE WAS NOT PRESENT AT THE CASE. CAUSE OF THE COMPONENT SEPARATION IS UNKNOWN. IT WAS REPORTED THAT ACCESS WAS GAINED VIA THE PATIENT'S ARM AND MULTIPLE (QUANTITY UNKNOWN) GORE® VIABAHN® ENDOPROSTHESES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE USED IN THE PATIENT'S LEFT INTERNAL AND LEFT COMMON ILIAC ARTERIES IN A KISSING TECHNIQUE TO RELINE THE SEPARATED DEVICES. NO GORE® EXCLUDER® INTERNAL ILIAC COMPONENT WAS LOCATED IN THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. THE REINTERVENTION WAS REPORTEDLY SUCCESSFUL AND THE ENDOLEAK WAS SUCCESSFULLY TREATED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16076132 ↗
• InjuryAug 31, 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) 2021, 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 (DATE AND MODALITY IS UNKNOWN), REVEALED A DISTAL TYPE I ENDOLEAK. A REINTERVENTION ON (B)(6) 2022. THE PHYSICIAN PLACED AN ILIAC BRANCH ENDOPROSTHESIS ON THE LEFT SIDE AND A CEB231010A & 8LVBX BY 79 WAS USED/IMPLANTED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PLC231200/ 23153505 UDI 00733132618569.

  Patient problems: Aneurysm

  MAUDE report 15331147 ↗
• InjuryAug 4, 2022Improper or Incorrect Procedure or Method; Malposition of Device; Unintended Movement; Improper or Incorrect Procedure or Method; Malposition of Device; Unintended Movement

  ON (B)(6) 2022, THE PATIENT UNDERWENT THE ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL ANEURYSM AND A COMMON ILIAC ARTERY ANEURYSM. REPORTEDLY, A PLC231200/24868712 DEVICE WHICH WAS USED AS A BRIDGING PIECE BETWEEN THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (EXCLUDER C3) AND THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) IMMEDIATELY MOVED DISTALLY ON DEPLOYMENT. IT WAS REPORTED THAT THE PHYSICIAN ASSISTING DEPLOYED AT A FAST RATE- QUICKLY THAN ADVISED BY THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), AND THE BRIDGING PIECE WAS DEPLOYED FULLY BEFORE THERE WAS TIME TO MOVE THE LIMB MORE PROXIMALLY. THE DISTAL LANDING WAS BELOW THE LEVEL OF THE FLOW DIVIDING INSIDE THE IBE AND WAS UNABLE TO BE MOVE PROXIMALLY. THIS CAUSED THE FLOW OBSTRUCTION OF THE INTERNAL ILIAC ARTERY (IIA). THE INTERNAL ILIAC BECAME THROMBOSED DUE TO THE LACK OF FLOW. IT WAS REPORTED THAT INITIALLY THERE WAS SOME SLOW FLOW TO THE IIA. AFTER MANY UNSUCCESSFUL ATTEMPTS WERE MADE TO RESTORE A FULL FLOW TO THE IIA, THE FINAL RUN SHOWED NO FLOW. ALSO, THERE WAS THROMBUS IN TH

  Patient problems: Aneurysm; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 15170536 ↗
• InjuryMay 13, 2022Adverse 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 AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (AXIAL IMAGES WITH CONTRAST DATED (B)(6) 2022), REVEALED A POSSIBLE ENDOLEAK (GORE IMAGING SERVICES STATED DISTAL TYPE I ENDOLEAK WITH IMAGES PROVIDED). REPORTEDLY THERE IS ENLARGEMENT IN THE COMMON ILIAC ARTERY (AMOUNT OF GROWTH IS UNKNOWN). THE ENLARGEMENT IS CONTAINED IN THE COMMON ILIAC ARTERY AND HAS NOT TRAVELED INTO THE AORTA. A REINTERVENTION IS PLANNED. THE EVENT IS ONGOING AT THIS TIME.

  Patient problems: Aneurysm

  MAUDE report 14397078 ↗
• InjuryDec 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY AND UNDERWENT REINTERVENTION. THE PHYSICIAN RESOLVED THE TYPE 1B ENDOLEAK BY COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY AND EXTENDING THE EXISTING AAA DEVICE (11025248/ PLC231200) INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND RESOLUTION OF THE ENDOLEAK WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919057 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FSA REPORTED: ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. DURING THE INITIAL IMPLANT PROCEDURE, THE CONTRALATERAL LEG ENDOPROSTHESIS WAS OVERLAPPED BY 3-4CM. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN), REVEALED A TYPE III ENDOLEAK (COMPONENT DISCONNECTION) DUE TO DEVICE DISTAL MIGRATION. THERE IS NO ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2021, A REINTERVENTION OCCURRED. THE PHYSICIAN IMPLANTED A CONTRALATERAL LEG ENDOPROSTHESIS (231400 LIMB) ACROSS THE TWO DISCONNECTED PARTS. THE DOCTORS GAINED ACCESS THROUGH THE DISUNION AND BRIDGED IT WITH A CONTRALATERAL LEG ENDOPROSTHESIS (231400 LIMB). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12586965 ↗
• InjuryOct 4, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS SELECTED TO TREAT A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM. THE LEFT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED WHEN DEPLOYING THE CONTRALATERAL LEG ENDOPROSTHESIS PLC231200. IT WAS REPORTED THAT THE DEVICE WAS PLACED LOWER THAN INTENDED. IT IS NOT REPORTED WHETHER THE COVERAGE LEAD TO ANY PATIENT HARM. THE PATIENT IS DOING WELL AND ROUTINE FOLLOW UP WILL BE CARRIED OUT.

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

  MAUDE report 12567045 ↗
• InjuryJun 1, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  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: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11914543 ↗
• InjuryNov 25, 2020Positioning Failure; Positioning Failure

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. ON (B)(6) 2020, FOLLOW-UP IMAGING DETERMINED A DISTAL TYPE I ENDOLEAK ORIGINATING FROM THE CONTRALATERAL LEG COMPONENT WHICH IS BELIEVED TO HAVE MIGRATED PROXIMALLY DUE TO ANEURYSMAL PROGRESSION OF THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN PLANS TO REINTERVENE HOWEVER A TREATMENT PLAN HAS NOT YET BEEN FINALIZED.

  Patient problems: Aneurysm

  MAUDE report 10900075 ↗
• InjuryNov 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2018, THE PATIENT PRESENTED WITH AN AORTIC ANEURYSM REACHING TO THE ILIAC ARTERY WHICH WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. ON (B)(6) 2020, A COMPUTED TOMOGRAPHY ANGIOGRAPHY SUGGESTED AN ENDOLEAK. ON (B)(6) 2020, AN ANGIOGRAPHY CONFIRMED THAT THE BRIDGING CONTRALATERAL LEG ENDOPROSTHESIS (PLC231200) DISCONNECTED RESULTING IN A TYPE III ENDOLEAK. GROWTH OF THE ANEURYSMAL SAC WAS NOTICED. ON (B)(6) 2020 THE ENDOLEAK WAS RESOLVED DURING A REINTERVENTION. THE BRIDGE WAS EXTENDED WITH ANOTHER CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200).

  Patient problems: No Code Available

  MAUDE report 10842790 ↗
• MalfunctionDec 3, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR BILATERAL ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG COMPONENT WERE SUCCESSFULLY DEPLOYED. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED TO DELIVER A CONTRALATERAL LEG COMPONENT BUT, ADVANCED OUTSIDE OF THE INTRODUCER SHEATH TO THE CONTRALATERAL GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PATIENT'S ANATOMY WAS REPORTED TO HAVE BEEN TORTUOUS AND DURING ADVANCEMENT OF THE CONTRALATERAL LEG COMPONENT IT GOT CAUGHT ON THE CONTRALATERAL GATE DURING AN ATTEMPT AT CANNULATION. THE CONTRALATERAL LEG COMPONENT WAS REPORTEDLY TORQUED AND ROTATED, OUTSIDE OF THE INTRODUCER SHEATH, IN AN ATTEMPT TO CANNULATE. MULTIPLE ATTEMPTS TO MANIPULATE THE DEVICE OUTSIDE THE SHEATH WERE MADE BUT UNSUCCESSFUL; AND A DECISION TO REMOVE THE DEVICE WAS MADE. DURING WITHDRAWAL OF THE UNDEPLOYED DEVICE THROUGH THE INTRODUCER SHEATH, IT WAS REPORTED THAT THE DELIVERY CATHETER BECAME CAUGHT AT VALVE OF THE SHEATH AND COULD NOT BE WITHDRAWN FURT

  Patient problems: Aneurysm

  MAUDE report 9404144 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 54MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. FOLLOW UP CTA SHOWED THAT FROM (B)(6) 2017 TILL (B)(6) 2018, THE ANEURYSM INCREASED IN SIZE FROM 55MM TO 60MM. IT WAS REPORTED THAT ON (B)(6) 2018, A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2019, A COIL EMBOLIZATION PROCEDURE WAS PERFORMED TO TREAT AN ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 8552424 ↗

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