GORE EXCLUDER AAA Endoprosthesis PLA260300Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132618774), received between Nov 9, 2018 and Oct 15, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, CONTRALATERAL LEG AND AN AORTIC EXTENDER). ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION TO PLACE A PROXIMAL GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DUE TO A SUSPECTED TYPE 1A ENDOLEAK AS IT DID NOT HAVE WALL APPOSITION ON THE PROXIMAL NECK AS IT WAS EXTREMELY ANGLED. REPORTEDLY, PATIENT WAS LOST TO FOLLOW UP AND THE ANEURYSM HAD INCREASED IN SIZE FROM 5.5 TO 8.5CM AND REINTERVENTION PROCEDURE WENT WELL WITH PATIENT DOING OKAY AFTER PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23295334 ↗
• InjuryJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2025 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDERS COMPONENTS AND ONE GORE® EXCLUDER® AORTIC EXTENDERS COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED TYPE II OR TYPE III ENDOLEAK BETWEEN THE FIRST (MOST DISTAL CXA260005) AND SECOND (MIDDLE PLA260300) AORTIC EXTENDER COMPONENTS. AN ADDITIONAL GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDERS COMPONENT WAS IMPLANTED TO RELINE THE SEAL OF THE TWO DEVICES. THERE WAS NO ANEURYSM ENLARGEMENT REPORTED AND THE TYPE ENDOLEAK WAS UNABLE TO BE DETERMINED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 22580201 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2024, THE PATIENT UNDERWENT A PRE-PLANNED STAGED SURGERY TO TREAT A SUBCLAVIAN THORACIC ANEURYSM. THE PATIENT WAS REPORTEDLY AT HIGH RISK FOR SURGERY. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) WAS IMPLANTED. IT WAS REPORTED THAT DURING THIS PROCEDURE A COOK DILATOR WAS BEING USED TO THEN ADVANCE A GORE® DRYSEAL SHEATH 26FR. THE COOK DILATOR POKED A HOLE IN THE NATIVE AORTIC ARTERY 2CM ABOVE THE BIFURCATION. TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO COVER THE HOLE. THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESES WERE THEN IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY FOUR HOURS POST PROCEDURE ON (B)(6) 2025, THERE WAS PAIN AND BLEEDING FROM THE INCISION SITE. IMAGES REVEALED THAT THE HOLE WAS NOT COMPLETELY SEALED. A REINTERVENTION OCCURRED AND TWO ADDITIONAL GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED. TWO UNITS OF BLOOD WERE GIVEN DURING THE REINTERVENTION PROCEDURE. THE PATIENT TOLERATED THE REINTERVE

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21590203 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2024, THE PATIENT UNDERWENT A PRE-PLANNED STAGED SURGERY TO TREAT A SUBCLAVIAN THORACIC ANEURYSM. THE PATIENT WAS REPORTEDLY AT HIGH RISK FOR SURGERY. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) WAS IMPLANTED. IT WAS REPORTED THAT DURING THIS PROCEDURE A COOK DILATOR WAS BEING USED TO THEN ADVANCE A GORE® DRYSEAL SHEATH 26FR. THE COOK DILATOR POKED A HOLE IN THE NATIVE AORTIC ARTERY 2CM ABOVE THE BIFURCATION. TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO COVER THE HOLE. THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESES WERE THEN IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY FOUR HOURS POST PROCEDURE ON (B)(6) 2025, THERE WAS PAIN AND BLEEDING FROM THE INCISION SITE. IMAGES REVEALED THAT THE HOLE WAS NOT COMPLETELY SEALED. A REINTERVENTION OCCURRED AND TWO ADDITIONAL GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED. TWO UNITS OF BLOOD WERE GIVEN DURING THE REINTERVENTION PROCEDURE. THE PATIENT TOLERATED THE REINTERVE

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21590181 ↗
• InjuryNov 27, 2024Partial Blockage; Activation, Positioning or Separation Problem; Migration; Partial Blockage; Activation, Positioning or Separation Problem; Migration

  ON (B)(6) 2024, THE PATIENT UNDERWENT URGENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, NO IMAGING WAS OBTAINED AS IT WAS ORIGINALLY PLANNED FOR A MEDTRONIC GRAFT. THE MEDTRONIC GRAFT WAS TOO LONG FOR THE CONTRA GATE TO OPEN ABOVE THE BIFURCATION THEREFORE THE PHYSICIAN DECIDED TO USE GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, UPON ARRIVAL OF THE GORE SALES FIELD ASSOCIATE, THE BRIEF ACCESS TO VIEW THE IMAGES WERE DONE AND IT WAS NOTED THAT THERE WAS MODERATE CALCIFICATION AROUND THE POSTERIOR WALL OF THE PROXIMAL LANDING ZONE. THIS WAS MENTIONED TO THE PHYSICIAN; HOWEVER, THE PROCEDURE WAS PROCEEDED. THE PHYSICIAN ADVANCED THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (RLT261412) AND AFTER PERFORMING AN ANGIOGRAPHIC RUN, POSITIONED THE TRUNK-IPSILATERAL LEG BELOW THE LOWEST RIGHT RENAL ARTERY, AND REMOVED THE WHITE OUTER DEPLOYMENT KNOB. AFTER CANNULATING THE CONTRALATERAL GATE, THEY MEASURED THE LENGTH REQUIRED FOR THE 14.5MM CONTRA LIMB AND DEPLOYED THE LIMB. THE PHYSICIAN THEN REMOVED THE CONSTRAINING MECHANISM, THEN DEPLOYED THE IPSILATERAL LEG. THERE WAS SUFFICIENT LENGTH AND S

  Patient problems: Clinical Endoleak; Reduced Blood Flow

  MAUDE report 20802531 ↗
• InjuryOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE THAT WAS PERFORMED ON AN UNKNOWN DATE TO TREAT AN ABDOMINAL AORTIC ANERUYSM (DIAMETER NOT PROVIDED). THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), 2015. ON (B)(6), 2016, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 64MM. ON (B)(6), 2023, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 92MM WHICH IS THOUGHT TO BE DUE TO A PROXIMAL TYPE I ENDOLEAK. ADDITIONALLY, IT WAS DETERMINED THAT THE PATIENT HAD A SEVERE AORTIC STENOSIS AND THE PATIENT UNDERWENT REINTERVENTION EMERGENT ENDOVASCULAR TREATMENT. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ISSUES. ON (B)(6), 2023, THE PATIENT UNDERWENT ADDITIONAL REINTERVENTION FOR TREATMENT OF A SEVERE AORTIC STENOSIS AND TRANSCATHETER AORTIC VALVE REPLACEMENT WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR 32 HOURS AND RECOVERED WELL.

  Patient problems: Aneurysm expansion

  MAUDE report 17917222 ↗
• InjuryFeb 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) , 2021, FOLLOW-UP IMAGING DETERMINED A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2022, IT WAS REPORTED THAT THE PHYSICIAN INTENDS TO REINTERVENE BUT HAS NOT SCHEDULED A REINTERVENTION AS OF YET WITH THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 13581959 ↗
• InjuryFeb 21, 2022Difficult or Delayed Activation; Malposition of Device; Difficult or Delayed Activation; Malposition of Device

  ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (RLT231412 / 23646178) TO TREAT AN AORTIC RUPTURE. ACCORDING TO THE INFORMATION PROVIDED, THE PROXIMAL DEVICE LANDED SLIGHTLY LOWER THAN PLANNED, BUT AS THIS WAS A RUPTURE CASE DONE IN THEATRE WITH A PORTABLE II, IT WAS DECIDED WITH THE LENGTH OF NECK THAT A SEAL SHOULD HAVE BEEN ACHIEVED ¿ THERE WAS NO ENDOLEAK NOTED ON THE FINAL CONTRAST RUN. HOWEVER, THE IMAGING QUALITY WAS POOR. ON AN UNKNOWN DATE, AFTER THE INITIAL PROCEDURE, THE COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT (PLA260300/ 20755264) TO TREAT A PROXIMAL TYPE I ENDOLEAK. THE DEVICE WAS IMPLANTED FROM THE RIGHT SIDE AND EXTENDED THE MAIN BODY BY APPROX. 10MM. (THE INFORMATION RELATED WITH A PROXIMAL TYPE I ENDOLEAK WAS REPORTED TO FDA). REPORTEDLY, THE PROXIMAL MARKERS SITUATED BELOW THE LEFT RENAL ARTERY (LOWEST). THE PHYSICIAN STARTED TO STEADY WITHDRAWAL OF THE DELIVERY CORD. IT WAS REPORTED THAT HALFWAY THROUGH THE DEPLOYMEN

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

  MAUDE report 13573542 ↗
• InjuryJul 16, 2021Partial Blockage; Partial Blockage

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. POST DEPLOYMENT OF THE DEVICES, IMAGING DETERMINED A SMALL PROXIMAL TYPE I ENDOLEAK. A GORE® MOLDING & OCCLUSION BALLOON (MOB) WAS USED TO PERFORM ADDITIONAL ANGIOPLASTY OF THE PROXIMAL TRUNK. DURING ANGIOPLASTY IT WAS REPORTED THAT THE MOB WAS PLACED WITH A SMALL PORTION OF THE BALLOON OUTSIDE THE PROXIMAL TRUNK AND WITHIN THE AORTA, CAUSING A RUPTURE OF THE AORTA AT THE LEVEL OF THE RENAL ARTERIES DUE TO OVERINFLATION OF THE MOB. THE PATIENT UNDERWENT MULTIPLE TRANSFUSIONS WHILE RECEIVING TREATMENT OF THE RUPTURE. FOUR GORE® AORTIC EXTENDERS COMPONENTS AND TWO PALMZ 40X10 STENTS WERE IMPLANTED TO TREAT THE RUPTURE. THE RENAL ARTERIES WERE INTENTIONALLY COVERED AND THE AORTA WAS GRAFTED UP TO THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY (SMA). THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN CRITICAL CONDITION. THE PATIENT EXPIRED DUE TO CARDIAC FAILURE AT 11:00PM THIS SAME DAY.

  Patient problems: Aneurysm

  MAUDE report 12185980 ↗
• InjuryJul 16, 2021Partial Blockage; Partial Blockage

  ON (B)(6), 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. POST DEPLOYMENT OF THE DEVICES, IMAGING DETERMINED A SMALL PROXIMAL TYPE I ENDOLEAK. A GORE® MOLDING & OCCLUSION BALLOON (MOB) WAS USED TO PERFORM ADDITIONAL ANGIOPLASTY OF THE PROXIMAL TRUNK. DURING ANGIOPLASTY IT WAS REPORTED THAT THE MOB WAS PLACED WITH A SMALL PORTION OF THE BALLOON OUTSIDE THE PROXIMAL TRUNK AND WITHIN THE AORTA, CAUSING A RUPTURE OF THE AORTA AT THE LEVEL OF THE RENAL ARTERIES DUE TO OVERINFLATION OF THE MOB. THE PATIENT UNDERWENT MULTIPLE TRANSFUSIONS WHILE RECEIVING TREATMENT OF THE RUPTURE. FOUR GORE® AORTIC EXTENDERS COMPONENTS AND TWO PALMZ 40X10 STENTS WERE IMPLANTED TO TREAT THE RUPTURE. THE RENAL ARTERIES WERE INTENTIONALLY COVERED AND THE AORTA WAS GRAFTED UP TO THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY (SMA). THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN CRITICAL CONDITION. THE PATIENT EXPIRED DUE TO CARDIAC FAILURE AT 11:00PM THIS SAME DAY.

  Patient problems: Aneurysm

  MAUDE report 12185976 ↗
• InjuryMar 10, 2021Adverse 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 MEASURING 86MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ALSO, THE AORTIC BRANCH VESSEL PROCEDURE WAS DONE, AND THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED. REPORTEDLY, THE AMPLATZER PLUG PLACED WITHIN THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT IS ENROLLED IN THE GRT 10-11 STUDY. THE PATIENT TOLERATED THE INITIAL PROCEDURE. THE FOLLOW-UP ON (B)(6) 2016, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 82MM. THE FOLLOW-UP ON (B)(6) 2016, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 65.7MM. REPORTEDLY, FROM JUNE 5, 2017 TO JANUARY 17, 2020, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 70MM TO 97MM. IT WAS REPORTED THAT ON (B)(6) 2020, A TYPE II ENDOLEAK WAS DETERMINED. REPORTEDLY, THE CT DID NOT IDENTIFY A SPECIFIC ENDOLEAK, HOWEVER, CONCERNS AROSE REGARDING LUMBAR ARTERIES EXTENDING BACK TOWARDS THE SAC THAT COULD BE CONTRIBUTING. ON (B)(6) 2020, THE ANGIOGRAM WAS PERFORMED AND THE PRESENCE OF THE LUMBAR ARTERY EXTENDING BACK TOWARDS THE AORTIC SAC WAS IDENTIFIED. THE SAME DAY, ON (B)(6) 2

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

  MAUDE report 11455159 ↗
• MalfunctionMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST AND ABDOMINAL PAIN. COMPUTED TOMOGRAPHY IMAGES SHOWED A 7.4CM AAA. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE DISTAL TIP OF THE AORTIC EXTENDER ENDOPROSTHESIS (FROM THE PROXIMAL OLIVE DOWN) BROKE OFF, IT STAYED ON THE GUIDEWIRE AND WAS SNARED BACK INTO THE SHEATH AND OUT OF THE BODY WITH NO HARM TO PATIENT. AN 18FR COOK SHEATH WAS USED ON THE RIGHT SIDE AND 12FR GORE DRY SEAL ON THE LEFT SIDE. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, ILIAC EXTENDER ENDOPROSTHESIS, AND AORTIC EXTENDER ENDOPROSTHESIS WENT THROUGH THE 18FR SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10039697 ↗
• InjuryFeb 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE IN 2006, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES (UNKNOWN). REPORTEDLY, THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT FOR KIDNEY STONES AND HAD CT IMAGING (DATE UNKNOWN). DURING THAT SCAN, IT WAS NOTED AN INCREASE IN SIZE OF THE ANEURYSM SAC FROM A PREVIOUS CT DATED (B)(6) 2013. IN 2013 THE ANEURYSM SAC MEASURED 6.4 X 6.7. ON THE RECENT CT (NONCONTRASTED) THE ANEURYSM SAC WAS FOUND TO MEASURE 8.3 X 7.5. THE PHYSICIAN DISCUSSED THE ANEURYSM ENLARGEMENT WITH A PATIENT ON (B)(6) 2015. ALSO, A TYPE II ENDOLEAK FROM A LEFT-SIDED LUMBAR IN THE NECK OF THE ANEURYSM WAS NOTICED. ON (B)(6) 2015, THIS PATIENT UNDERWENT A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND ALSO, A TRANSABDOMINAL SAC EMBOLIZATION PROCEDURE FOR A TYPE II ENDOLEAK WAS PERFORMED. DURING THE PROCEDURE THE AORTIC BRANCH VESSEL PROCEDURES (CHIMNEY) WAS DONE IN THE RIGHT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, FROM (B)(6) 2016 TO (B)(6) 2017, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 86MM TO 91MM AND A SMALL

  Patient problems: Aneurysm

  MAUDE report 8337965 ↗
• InjuryNov 9, 2018Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH A NON-GORE MANUFACTURED STENT-GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS (PLA260300/13956410, PLA260300/14834638, AND PLA260300/14241662) TO TREAT DISTAL MIGRATION OF THE INITIALLY IMPLANTED STENT-GRAFT SYSTEM. ON (B)(6) 2018, FOLLOW-UP IMAGING REPORTEDLY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY A ¿SNORKEL¿ WAS PLACED IN THE LEFT RENAL ARTERY, THE STENT GRAFT SYSTEM WAS EXTENDED PROXIMALLY, AND A BARE METAL STENT WAS PLACED IN THE RIGHT RENAL ARTERY TO PRESERVE BLOOD FLOW. ACCORDING TO THE REPORT, THE SNORKEL IN THE LEFT RENAL ARTERY BECAME OCCLUDED. NO FURTHER TREATMENT WAS RENDERED TO TREAT THE OCCLUSION, AND THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056269 ↗

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)