GORE EXCLUDER AAA Endoprosthesis PXT261414Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132610228), received between Jun 21, 2018 and Mar 12, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT261414/(B)(6), PXC201000/(B)(6), PXC201400/(B)(6). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR ANEURYSM ENLARGEMENT. THE PHYSICIAN STATED NO ALLEGATION AGAINST DEVICES AND BELIEVES THE GROWTH IS DUE TO DISEASE PROGRESSION. THE PHYSICIAN CHOSE TO REINTERVENE AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (CEB231210A/(B)(6) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXAL083901A/UNK) AND A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT WERE IMPLANTED. THE PHYSICIAN EXTENDED PROXIMALLY FROM THE TRUNK IPSILATERAL LEG WITH THE AORTIC EXTENDER CONFORMABLE AND THE ILIAC BRANCH COMPONENT WAS PUT IN THE RIGHT COMMON ILIAC ARTERY AND EXTENDED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE WITHIN THE RIGHT INTERNAL ILIAC ARTERY. THE LEFT SIDE WAS EXENDED DISTALLY WITH A CONTRALATERAL LEG COMPONENT. IT IS UNKNOWN WHICH CONTRALATERAL LEG WAS ON THE LEFT SIDE FROM THE INITIAL PROCEDURE. ON (B)(6) 2024, PATIENT WAS DISCHARGED AND IS DOING WELL. ON (B)(6) 2025, THE PATIENT

  Patient problems: Aneurysm expansion

  MAUDE report 21589864 ↗
• InjuryDec 12, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B UNCOMPLICATED AORTIC DISSECTION AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (PXT261414/(B)(6) AND PXC161400/10667830). AN AORTIC BRANCH VESSEL PROCEDURE WAS ALSO PERFORMED ON THE LEFT RENAL ARTERY, WHEREIN IT WAS STENTED WITH A STENT EXPRESS ¿ SD (BOSTON SCIENTIFIC) ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2014 WITH NO REPORTED ENDOLEAK OR OTHER COMPLICATIONS. ON (B)(6) 2015, FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 36MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2018, DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS MEASURED 59MM. ADDITIONALLY, ON NOVEMBER 13, 2018, AN ENDOLEAK AND A DISSECTION WERE NOTED. ON (B)(6) 2019, THE PATIENT UNDERWENT THE EMBOLIZATION PROCEDURE USING DMSO. ALSO, THE ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED AND THE ENDARTERECTOMY PROCEDURE FOR BOTH FEMORAL ARTERY WAS PERFORMED. BASED ON THE CONVERSATION WITH THE PHYSICIAN, THE EVENT WAS NOT RELATED WITH THE DEVICE OR PROCEDURE. BASED ON INFORMATION AVAILABLE, THE EVENT

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20919585 ↗
• InjuryJun 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND TWO CONTRALATERAL LEGS). ON (B)(6) 2024, REPORTEDLY, PATIENT WAS LOST TO FOLLOW UPS. THERE IS SUBSTANTIAL ANEURYSMAL GROWTH (SIZE UNKNOWN) OVER THE LAST 14 YEARS, PHYSICIAN STATED NO ALLEGATION AGAINST DEVICES BUT THE GROWTH IS DUE TO DISEASE PROGRESSION AND PHYSICIAN DECIDED TO DO AN ELECTIVE REINTERVENTION PROCEDURE. THE PATIENT UNDERWENT REINTERVENTION PROCEDURE TO TREAT ANEURYSMAL GROWTH UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (ILIAC BRANCH COMPONENT) AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE). PHYSICIAN EXTENDED PROXIMALLY FROM THE TRUNK IPSILATERAL LEG WITH THE AORTIC EXTENDER CONFORMABLE AND THE ILIAC BRANCH COMPONENT WAS PUT IN THE RIGHT COMMON ILIAC ARTERY THEN BRIDGED WITH DISTAL EXTENSION ON THE LEFT. IT IS UNKNOWN WHICH CONTRALATERAL LEG WAS ON THE LEFT SIDE FROM THE INITIAL PROCEDURE. ON (B)(6) 2024, PATIENT WAS DISCHARGED AND IS DOING WELL.

  Patient problems: Aneurysm expansion

  MAUDE report 19495673 ↗
• InjuryJul 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS OBTAINED FROM PROGRAM AND ABSTRACTS OF THE 29TH ANNUAL MEETING OF THE JAPANESE SOCIETY OF ENDOVASCULAR INTERVENTION. NORIHIRO ANDO, ET AL. FOUR CASES THAT REQUIRED OPEN SURGERY AFTER ENDOVASCULAR AORTIC REPAIR. THE AUTHORS REPORT ON 4 CASES OF ANEURYSM ENLARGEMENT OR RUPTURE DUE TO ENDOLEAK (EL) FOLLOWING ENDOVASCULAR AORTIC REPAIR (EVAR) THAT REQUIRED OPEN SURGERY. THE CASES WERE FOUR MALE PATIENTS IN THEIR 70S OR 80S. TWO WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND THE OTHER TWO WERE TREATED WITH MEDTRONIC ENDURANT. IN 2 EXCLUDER CASES AND 1 ENDURANT CASE, ANEURYSM ENLARGEMENT DUE TO TYPE II EL OCCURRED, AND TRANSARTERIAL LUMBAR ARTERY EMBOLIZATION AND PERCUTANEOUS LUMBER ARTERY EMBOLIZATION WERE PERFORMED; HOWEVER, THE ENLARGEMENT CONTINUED AND THUS, SURGICAL ANEURYSMORRHAPHY WAS PERFORMED. AFTER THE SURGERY, ANEURYSM SHRINKAGE WAS SHOWN IN 2 CASES. ALTHOUGH FURTHER ENLARGEMENT WAS NOTED IN 1 CASE, IT STOPPED 2 YEARS LATER.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17398010 ↗
• InjurySep 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B UNCOMPLICATED AORTIC DISSECTION AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (PXT261414/11132081 AND PXC161400/10667830). AN AORTIC BRANCH VESSEL PROCEDURE WAS ALSO PERFORMED ON THE LEFT RENAL ARTERY, WHEREIN IT WAS STENTED WITH A STENT EXPRESS ¿ SD (BOSTON SCIENTIFIC) ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON FEBRUARY 12, 2014 WITH NO REPORTED ENDOLEAK OR OTHER COMPLICATIONS. ON (B)(6) 2015, FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 36MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2018, DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS MEASURED 59MM. ADDITIONALLY, ON (B)(6) 2018, AN ENDOLEAK AND A DISSECTION WERE NOTED. ON (B)(6) 2019, THE PATIENT UNDERWENT THE EMBOLIZATION PROCEDURE USING DMSO. ALSO, THE ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED AND THE ENDARTERECTOMY PROCEDURE FOR BOTH FEMORAL ARTERY WAS PERFORMED. ACCORDING TO THE SITE, THE EVENT WAS NOT RELATED TO DEVICE OR PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SITE. BASED ON THE CONV

  Patient problems: Aneurysm; Clinical Endoleak; Vascular Dissection

  MAUDE report 15397807 ↗
• InjuryJul 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, A TYPE II ENDOLEAK WAS REPORTEDLY OBSERVED. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED WITHOUT FURTHER TREATMENT. ON (B)(6) 2022, GRADUAL ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ABDOMINAL ULTRASONOGRAPHY REPORTEDLY REVEALED A PROXIMAL TYPE I ENDOLEAK. IT WAS SUGGESTED THAT TYPE I APPEARED BECAUSE THE SEAL ZONE BECAME SHORTER AS THE DIAMETER OF THE ANEURYSM ENLARGED. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION WHEREBY ADDITIONAL STENT GRAFTS WERE IMPLANTED TO EXTEND THE DEVICE SYSTEM PROXIMALLY, AND TO EXTEND THE BILATERAL LIMBS DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 15134767 ↗
• InjuryJul 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012. THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, A TYPE II ENDOLEAK WAS REPORTEDLY OBSERVED. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED WITHOUT FURTHER TREATMENT. ON AN UNKNOWN DATE IN 2016, ANEURYSM ENLARGEMENT WAS REPORTEDLY OBSERVED, AND THE PATIENT UNDERWENT OPEN SURGICAL REPAIR. ACCORDING TO THE REPORT, ANEURYSMORRHAPHY AND BRANCH LIGATION INCLUDING THE LUMBAR ARTERY WERE PERFORMED. THE TYPE II ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 15130127 ↗
• InjuryFeb 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2004, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT A REINTERVENTION. A TYPE IA ENDOLEAK WAS SUSPECTED BETWEEN THE RENALS AND THE PROXIMAL END OF THE MAIN BODY OF THE GRAFT. THE ENDOLEAK COULD NOT BE CONFIRMED, BUT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED AS A PRECAUTION. IN ADDITION, AT TYPE III ENDOLEAK WAS SUSPECTED BETWEEN THE DISTAL END OF THE MAIN BODY AND ONE OF THE CONTRALATERAL LEG SEGMENTS, (UNKNOWN WHICH ONE). AGAIN, THE ENDOLEAK WAS NOT CONFIRMED, BUT AS A PRECAUTION, TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 13453423 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM. NON-GORE BARE METAL STENTS (LUMINEXX) WERE IMPLANTED TO RELINE BILATERAL LEGS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT BILATERAL COMMON ILIAC BECAME ANEURYSMAL IN THE TREATED AREA. ENDOLEAKS WERE NOTED BILATERALLY. THE BILATERAL INTERNAL ILIAC ARTERIES WERE EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE DEPLOYED TO EXTEND THE DEVICE TO BILATERAL EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. (THIS WAS REPORTED ON MFR REPORT # 2017233-2021-02392) ON (B)(6) 2021, A TYPE III DISCONNECT ENDOLEAKS BETWEEN THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS AND CONTRALATERAL LEG ENDOPROSTHESES WAS DISCOVERED BY POSTOPERATIVE COMPUTER TOMOGRAPHY IMAGE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION. BILATERAL LIMBS WERE RELINED WITH ADDITIONAL STENT GRAFTS. THE TYPE III ENDOLEAKS WERE RESOLVED. DURING THE PROCEDURE, A SLIGHT TYPE II ENDOLEAK WAS OBSERVED, AND THE ENDOLEAK WILL BE MONITORED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED AS FOLLOWS; THE BMS (LUMINEX 14MM-60MM) ON BOTH SIDES THAT IMPLANTED IN

  Patient problems: Aneurysm

  MAUDE report 12507697 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. NON-GORE BARE METAL STENTS (LUMINEXX) WERE IMPLANTED TO RELINE BILATERAL LEGS. DURING THE PROCEDURE, A TYPE II ENDOLEAK WAS NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, A PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED, SO AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED TO EXTEND THE DEVICE PROXIMALLY.

  Patient problems: Aneurysm

  MAUDE report 12507487 ↗
• InjuryApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2009, THE PATIENT WAS TREATED FOR AN AORTIC ABDOMINAL ANEURYSM. SIX EXCLUDER DEVICES WERE IMPLANTED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ANEURYSM. IT WAS DETERMINED THAT A TYPE III ENDOLEAK HAD OCCURRED BETWEEN TWO COMPONENTS, ALLOWING THE ANEURYSM TO EXPAND AND RUPTURE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS PLACE IN THE GAP BETWEEN THE TWO SEPARATED DEVICES. AFTER SUCCESSFULLY PLACING THE DEVICE, AS THE DELIVERY CATHETER WAS BEING REMOVED, THE OLIVE TIP SEPARATED FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE OLIVE, AND THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER WILL BE RETURNED FOR EVALUATION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11638050 ↗
• InjuryApr 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A SYSTEM OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ACCORDING TO THE REPORT, A TYPE II ENDOLEAK WAS OBSERVED POST-OPERATIVELY. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT. ON AN UNKNOWN DATE, FOLLOW-UP COMPUTED TOMOGRAPHIC ANGIOGRAPHY REPORTEDLY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). A PERSISTENT TYPE II ENDOLEAK WAS ALSO REPORTEDLY SEEN. THE TYPE II WAS THOUGHT TO ORIGINATE FROM THE INFERIOR MESENTERIC ARTERY. IT WAS REPORTED AN OPEN SURGICAL CONVERSION WOULD BE PERFORMED ON (B)(6) 2020. HOWEVER, FURTHER INFORMATION REGARDING THE PROCEDURE COULD NOT BE ACCESSED DUE TO THE COVID-19 PANDEMIC.

  Patient problems: No Code Available

  MAUDE report 10005211 ↗
• InjuryApr 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A SYSTEM OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ACCORDING TO THE REPORT, A TYPE II ENDOLEAK WAS OBSERVED POST-OPERATIVELY. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT. ON AN UNKNOWN DATE, FOLLOW-UP COMPUTED TOMOGRAPHIC ANGIOGRAPHY REPORTEDLY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN, ANEURYSM MEASUREMENT NOT AVAILABLE). THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS NOT REPORTED. A PERSISTENT TYPE II ENDOLEAK WAS ALSO REPORTEDLY SEEN. THE TYPE II WAS THOUGHT TO ORIGINATE FROM THE INFERIOR MESENTERIC ARTERY. IT WAS REPORTED AN OPEN SURGICAL CONVERSION WOULD BE PERFORMED ON (B)(6) 2020. HOWEVER, FURTHER INFORMATION REGARDING THE PROCEDURE COULD NOT BE ACCESSED DUE TO THE COVID-19 PANDEMIC.

  Patient problems: No Code Available

  MAUDE report 10005194 ↗
• InjuryMay 9, 2019Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2006 THE PATIENT HAD THREE GORE® EXCLUDER® AAA ENDOPROSTHESES IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF BACK PAIN AND HYPOTENSION. A CT SCAN WAS PERFORMED BUT DID NOT SHOW ANY RESULTS. THE PATIENTS SYMPTOMS CONTINUED AND ON (B)(6) 2019 AN ANGIOGRAM WAS PERFORMED AND WHAT LOOKED LIKE A HOLE APPEARED IN THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY RIGHT BELOW THE FLOW DIVIDER. ON (B)(6) 2019, A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED INSIDE THE ORIGINAL GORE® EXCLUDER® AAA ENDOPROSTHESIS MAINBODY AND IT WAS REPORTED THAT THE HOLE WAS SUCCESSFULLY COVERED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension; Pain

  MAUDE report 8597800 ↗
• InjuryApr 3, 2019Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Migration; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Migration

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PRE-TREATMENT MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 50MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. REPORTEDLY, FROM (B)(6) 2012 TO AUGUST 20, 2018, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 51MM TO 92MM. ON (B)(6) 2018, A PROXIMAL TYPE I ENDOLEAK DUE TO THE DEVICE MIGRATION (UNKNOWN AMOUNT) WAS DETERMINED. REPORTEDLY, THE TYPE I ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT¿S ANATOMY CONTRIBUTED TO THE EVENT, AS THE AORTIC NECK WAS SHORT. ON (B)(6) 2019, THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE USING AN AORTIC ENDOGRAFT (UNKNOWN) TO TREAT THE ENDOLEAK AND THE ANEURYSM ENLARGEMENT. THE FOLLOW UP ULTRASOUND ON (B)(6) 2019, SHOWED THAT THE DIAMETER OF ANEURYSM WAS 91MM. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: Aneurysm

  MAUDE report 8480359 ↗
• InjuryAug 28, 2018Adverse 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) 2011, A PATIENT UNDERWENT TREATMENT OF A TYPE B UNCOMPLICATED AORTIC DISSECTION WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THIS PATIENT HAD PRIOR ENDOVASCULAR REPAIR WITH UNKNOWN DEVICES. THE MAXIMUM AORTIC DIAMETER MEASUREMENT WAS NOT GIVEN. ON (B)(6) 2011 THE MAXIMUM AORTIC DIAMETER WAS 69MM. ON (B)(6) 2012, THE MAXIMUM AORTIC DIAMETER WAS 67MM. ON (B)(6) 2015 THE MAXIMUM AORTIC DIAMETER WAS 68MM. ON (B)(6) 2015 THE PATIENT WAS REPORTED TO HAVE GROWING ANEURYSM AT THE PROXIMAL AORTIC NECK, AT THE LEVEL OF THE FIRST 3RD OF THE ENDOPROSTHESIS. ON (B)(6) 2015 AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED. ON (B)(6) 2015 THE PATIENT RETURNED FOR FOLLOW-UP WITH GOOD OUTCOME AND NO COMPLAINTS. ON (B)(6) 2016 THE MAXIMUM AORTIC DIAMETER WAS 69MM. ON SEPTEMBER 6, 2016 THE MAXIMUM AORTIC DIAMETER WAS 67MM. ON (B)(6) 2017 THE PATIENT PRESENTED WITH SEPSIS, UNRELATED TO THE DEVICES OR PROCEDURES. ON (B)(6) 2017 THE PATIENT EXPIRED.

  Patient problems: Aneurysm

  MAUDE report 7825349 ↗
• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THE EXCLUDER® AAA ENDOPROSTHESES WERE EXPLANTED ON (B)(6) 2018, AND REPLACED WITH AN OPEN REPAIR. THE ANEURYSM SAC HAD CONTINUED EXPANSION OVER THE PAST YEAR FOR UNKNOWN REASON. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7628062 ↗

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)