GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT311417Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00733132619092), received between Aug 14, 2018 and Jul 17, 2025 — classified as 1 death, 42 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (7 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 60 MM IN DIAMETER AND A LEFT INTERNAL ILIAC ANEURYSM. THEREFORE, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. ON (B)(6) 2017, A TYPE II ENDOLEAK WITH SAC EXPANSION WAS DIAGNOSED MEASURING 73 MM COMPARED TO 59 MM ON (B)(6) 2016. ON (B)(6) 2017, COIL EMBOLIZATION WAS PERFORMED. IT ALSO WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD DECIDED TO DISCONTINUE THE STUDY DUE TO POOR HEALTH CONDITION.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22528798 ↗
• InjuryFeb 6, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A PATIENT WAS TREATED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, A REINTERVENTION TOOK PLACE FOR A TYPE 1A ENDOLEAK. THE PHYSICIAN EXTENDED WITH TWO AORTIC EXTENDERS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21327210 ↗
• InjuryOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMOGRAPHY SHOWED AN ENDOLEAK AND THE PATIENT UNDERWENT RE-INTERVENTION. THE ORIGINAL DEVICES WERE RELINED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND EXCLUDER® LIMBS. DURING THE PROCEDURE IT WAS DETERMINED IT WAS A PROXIMAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 20563386 ↗
• InjurySep 11, 2024Migration; Migration

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT A SUCCESSFUL ENDOVASCULAR PROCEDURE WITH LEFT SIDED GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS PLACEMENT. IT WAS REPORTED THAT A FOLLOW-UP CTA PERFORMED ON (B)(6) 2024, SHOWED MIGRATION OF THE EXCLUDER MAIN BODY DEVICE. IT MIGRATED ABOUT 85 MM DISTAL TO THE RENAL ARTERIES. THE PROXIMAL NECK HAS DEGENERATED AND THE AAA SAC HAS GROWN CLOSE TO 1.5 CM SINCE PRE-EVAR. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND IS BEING REFERRED TO ANOTHER FACILITY TO LOOK INTO TREATMENT OPTIONS INCLUDING REINTERVENTION. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE EVENT TO OCCUR.

  Patient problems: Aneurysm expansion

  MAUDE report 20193114 ↗
• InjuryApr 18, 2024Migration; Migration

  ON (B)(6) 2020, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES, RLT311417, PLC141400, AND TWO PLL161407. THE PATIENT TOLERATED THE PROCEDURE. ON 27-MAR-2024, IMAGING SERVICES RECEIVED A SERIES OF IMAGES TAKEN ON 18-MAR-2024 OF A REPORTED MIGRATION. IT WAS REPORTED THAT ON A 4 YEAR FOLLOW UP VISIT, IT WAS SEEN THAT THE RLT HAD MIGRATED DISTALLY, WITH ANEURYSM ENLARGEMENT AND NO CLEAR INDICATION OF AN ENDOLEAK. A REINTERVENTION IS SCHEDULED FOR A FUTURE TIME.

  Patient problems: Aneurysm expansion

  MAUDE report 19134949 ↗
• InjuryApr 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES, RLT311417 AND PXC141400. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK ON THE RLT311417. THE PHYSICIAN IMPLANTED TWO AORTIC EXTENDERS TO STOP THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19060647 ↗
• InjuryMar 21, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311417, PLC141000 ON THE LEFT, AND PLC271000 ON THE RIGHT) WAS IMPLANTED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). ON (B)(6) 2024, THE PATIENT HAD A TEMPERATURE SPIKE AND LEFT ABDOMINAL PAIN AND LEFT KNEE PAIN. CT SHOWED FLUID COLLECTION RELATED TO THE LT ANTERIOR LATERAL LOWER ABDOMINAL AORTA AND PROMINENT SOFT TISSUE PROCESS RELATED TO THE LEFT COMMON AND EXTERNAL ILIAC ARTERIES. THE PHYSICIAN COULD NOT EXCLUDE THE POSSIBILITIES OF INFECTED FLUID COLLECTION OR INFECTED INFLAMMATORY PROCESS RELATED TO THE EVAR. ON (B)(6) 2024, THE PATIENT RECEIVED IV ANTIBIOTICS DUE TO HYDRONEPHROSIS AND PROXIMAL HYDROURETER. ON (B)(6) 2024, A PET CT SCAN SHOWED DIFFUSE ABNORMAL FDG UPTAKE SURROUNDING THE STENT AND THE WALLS OF THE RESIDUAL AAA SAC SUSPICIOUS FOR STENT INFECTION. A LARGE FDG - AVID FLUID COLLECTION IN THE LEFT PSOAS MUSCLE SURROUNDING THE LEFT ILIAC STENT MEASURING 6 CM IN AXIAL DIAMETER. NO OTHER FOCI OF ABDOMINAL FDG UPTAKE WAS OBSERVED. THE PHYSICIAN SUSPECT A PROBABLE INFECTION OF THE AORTIC ANEURYSM STENT ASSOCIATED WITH THE LARGE LEFT PSOAS MUSCLE ABSCESS AS DESCRIBED. THE PATIENT RECEIVED CONTINUED IV A

  Patient problems: Bacterial Infection; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18948199 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 55.5MM. THE FOLLOW UP CTA SCANS FROM (B)(6) 2019 TO (B)(6) 2021 SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 53MM TO 67MM. ON (B)(6) 2022, THE ELECTIVE ANGIOGRAM WAS PERFORMED AND A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2022, THE PATIENT UNDERWENT THE INFERIOR MESENTERIC ARTERY EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK. ACCORDING TO THE PHYSICIAN, THE TYPE II ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. THE LEAK WAS FIXED. THE PATIENT IS FINE. STABLE ANEURYSM DIAMETER AND UNDERGOING CONTINUED SURVEILLANCE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18764541 ↗
• InjuryNov 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018 PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESISA (RLT311417 ON THE RIGHT AND A PLC181400 ON THE LEFT). A PRIOR CTA IN 2018 SHOWED THE LIMB WAS WELL APPOSED AT THAT TIME AND PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2023 A FOLLOW-UP IMAGING SHOWED A SUSPECTED TYPE 2 ENDOLEAK INVOLVING A VERY LOW RIGHT ACCESSORY RENAL NEAR THE LEVEL OF THE AORTIC BIFURCATION WITH FLOW ALONG THE RIGHT SIDED LIMB. NO TREATMENT WAS PLANNED AT THIS TIME. ON (B)(6) 2023, AN ANGIOGRAM WAS PERFORMED AND SHOWED A TYPE 1B ENDOLEAK ON THE RIGHT SIDE WITH ANTEGRADE FILLING OF THE RIGHT ACCESSORY RENAL ARTERY. NO ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2023 REINTERVENTION SURGERY WAS PERFORMED. THE PHYSICIAN CHOSE TO COIL EMBOLIZE THE RIGHT ACCESSORY RENAL ARTERY AND THEN EXTENDED THE RIGHT SIDED LIMB WITH AN 18 MM EXCLUDER CONTRALATERAL COMPONENT. FSA ALSO REPORTS THERE WAS 4-5 CM OF ROOM BETWEEN THE END OF THE RLT311417 COMPONENT AND THE INTERNAL ILIAC ARTERY, WHICH ALIGNED WITH INITIAL DEVICE PLACEMENT, AND NO MIGRATION WAS NOTED. PHYSICIAN ATTRIBUTES THIS ENDOLEAK TO DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCED

  Patient problems: Clinical Endoleak

  MAUDE report 18070167 ↗
• InjurySep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 70MM; AND WAS IMPLANTED WITH GORE EXCLUDER AAA 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 COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 61MM. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 77MM. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD AN ENLARGING ANEURYSM DUE TO A TYPE II ENDOLEAK. THIS SAME DATE THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, OPEN AORTIC ENDOLEAK REPAIR, LIGATION OF MULTIPLE LUMBAR VESSELS AND LIGATION OF THE INFERIOR MESENTERIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), IT WAS REPORTED THAT THE PATIENT EXPIRED. A CAUSE OF DEATH FOR THE PATIENT WAS NOT PROVIDED. THE STUDY SITE REPORTED ADDITIONAL DETAILS AS FOLLOWS: YES THE PROCEDURE RESOLVED THE ENDOLEAK BUT THE PATIENT WAS DISCHARGED TO HOME WITH HOSPICE AFTER NOT DOING WELL AFTER THE OPEN PROCEDURE DUE TO A

  Patient problems: Aneurysm expansion

  MAUDE report 17738897 ↗
• InjuryJun 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT311417 AND PLC181000). COMPUTED TOMOGRAPHY (CT) IMAGING ON (B)(6), 2016, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 47 MM. MAXIMUM AORTIC ANEURYSM DIAMETER INCREASED TO 60 MM AS MEASURED WITH CT IMAGING ON (B)(6) 2023. ON (B)(6) 2023, THE IMPLANTED DEVICES WERE EXPLANTED DUE TO ANEURYSM GROWTH AND TYPE III ENDOLEAK CAUSED BY A FAULTY CONNECTION BETWEEN THE DEVICE PLACED IN THE LEFT ILIAC BRANCH (PLC181000) AND THE AORTIC MAIN BODY (RLT311417).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17133399 ↗
• InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AT AN OUTSIDE FACILITY (B)(6). ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED AT THE SAME FACILITY FOR AN ASSUMED TYPE 1A ENDOLEAK AND THREE PROXIMAL AORTIC EXTENDER COMPONENTS WERE IMPLANTED (PLA320400, CXA320005, CXA360005). THE PATIENT WAS TRANSFERRED TO UPMC ALTOONA MEDICAL CENTER AND ALL THE DEVICES WERE EXPLANTED ON (B)(6) 2023 BY DR. (B)(6) DUE TO A CONTINUED TYPE 1A ENDOLEAK. THE PATIENT HAD BEEN HAVING ABDOMINAL AND BACK PAIN THAT GOT PROGRESSIVELY WORSE OVER THE PAST FEW DAYS UNTIL IT BECAME UNBEARABLE. THE EXPLANT PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Clinical Endoleak

  MAUDE report 16956785 ↗
• InjuryMar 27, 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) 2013, 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 (MODALITY AND DATE IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. NO ANEURYSM SAC ENLARGEMENT. THERE WAS A REINTERVENTION ON (B)(6) 2023. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESES AORTIC EXTENDER IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16623183 ↗
• InjuryFeb 27, 2023Migration; Migration

  ADDITIONAL INFORMATION ON REINTERVENTION: ON (B)(6) 2023, THE PATIENT UNDERWENT A PLANNED ENDOVASCULAR REINTERVENTION IN ZONE 8-RENALS TO TREAT THE TYPE 1A ENDOLEAK UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414). THE PATIENT ANATOMY OF AORTA WAS TORTUOUS AND AN AORTO-UNI-ILIAC (AUI) WAS DONE, AS THE PHYSICIAN COULD NOT REACH THE CONTRA LEG. THE REINTERVENTION WAS DONE TO REALIGN THE ORIGINAL GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16444270 ↗
• InjuryDec 29, 2022Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON JULY 3, 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PATIENT PRESENTED WITH REPORTED MIGRATION OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THAT THE DEVICE HAD MIGRATED DISTALLY APPROXIMATELY 3-4CM DUE TO DISEASE PROGRESSION IN THE PATIENT'S PROXIMAL AORTIC NECK. A PROXIMAL TYPE I ENDOLEAK WAS ALSO PRESENT. THE PHYSICIAN OPTED TO TREAT THE DEVICE MIGRATION WITH REINTERVENTION WHEREBY THREE GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS WERE USED TO EXTEND THE TRUNK PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED AT THE CONCLUSION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND THE PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 16071037 ↗
• InjuryOct 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. ADDITIONALLY, IT WAS REPORTED THE PATIENT'S PROXIMAL NECK HAD SIGNIFICANT THROMBUS. THE PATENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN 2021, FOLLOW-UP IMAGING DETERMINED MIGRATION OF THE PROXIMAL TRUNK DEVICE. ON (B)(6) 2022, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM DUE TO APPROXIMATELY 5-5.CM MIGRATION OF THE PROXIMAL TRUNK. THE PREVIOUSLY IMPLANTED DEVICES WERE RELINED FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENTS LEFT RENAL ARTERY WAS INTENTIONALLY COVERED TO ACHIEVE BETTER DEVICE PURCHASE WITHIN THE ANATOMY. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONALLY, THE PHYSICIAN STATED THE PATIENT WAS NEVER A GOOD CANDIDATE FOR ENDOVASCULAR TREATMENT BACK IN 2019 OR PRESENT DAY. ENDOVASCULAR TREATMENT WAS PERFORMED AS IT WAS NOT BELIEVED THE PATIENT WOULD SURVIVE AN OPEN SURGICAL PROCEDURE. TREATMENT WAS OUTSIDE IFU DUE TO THE POOR QUALITY OF THE PATIENT¿S AORTIC ANATOMY. IMAGES WERE PROVIDED TO GORE AND AN EVALUATION SHOWED THE FOLLOWING: ON THE PRE-IMPLANT IMAGES DATE

  Patient problems: Ruptured Aneurysm

  MAUDE report 15523761 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PHYSICIAN REPORTED THAT THE PATIENT HAD A SUSPECTED PROXIMAL TYPE I ENDOLEAK OR A TYPE II ENDOLEAK AND PLANNED TO REINTERVENE ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION AND A CONFORMABLE AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY TO EXTEND COVERAGE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTS THAT WHILE NO ENDOLEAK WAS VISUALIZED, SOME ANEURYSM ENLARGEMENT WAS NOTED. THE PATIENT WAS REPORTED TO HAVE A SHORT ANGULATED NECK, EXACT DIMENSIONS WERE NOT PROVIDED BUT BELIEVED TO BE WITHIN TREATMENT RANGE RECOMMENDED. THE AMOUNT OF ENLARGEMENT WAS NOT KNOWN.

  Patient problems: Aneurysm

  MAUDE report 14718333 ↗
• MalfunctionJun 3, 2022Unintended Compatibility; Unintended Compatibility

  THE CSA REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (RLT311417/23929725) WAS PREPPED ON BACK TABLE PER THE INSTRUCTIONS FOR USE. WHILE ATTEMPTING TO ADVANCE THE DELIVERY CATHETER THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATH VALVE, THE VALVE RUPTURED. TWO ADDITIONAL GORE® DRYSEAL FLEX INTRODUCER SHEATHS WERE USED, AND THE VALVE¿S WERE RUPTURED. THE CSA INSTRUCTED THE DOCTOR TO NOT USE THIS DEVICE AT THIS POINT. REPORTEDLY A METAL PIECE (WAS DETERMINED BY RETURNED PRODUCT PHOTO'S TO BE A LOCK PIN) PUNCTURED THE SHEATH VALVE. THE LOCK PIN WAS NOT VISIBLE, IT WAS FELT ON THE BACK TABLE AFTER THE THIRD DRYSEAL FLEX SHEATH WAS PUNCTURED. THE LOCK PIN THAT WAS NOT VISIBLE WAS COMING FROM THE TOP OF THE GRAFT, NOT THE OLIVE. A HEMOSTAT WAS USED TO STOP BLOOD LOSS (AMOUNT OF BLOOD LOSS IS UNKNOWN). A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PHYSICIAN USED A DIFFERENT DEVICE AND A NEW SHEATH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14598578 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2014, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 54MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. REPORTEDLY, FOLLOW UP SCANS FROM (B)(6) 2015 TILL (B)(6) 2020 DETERMINED THAT THE ANEURYSM INCREASED IN SIZE FROM 45MM TO 71MM. ADDITIONALLY, ON (B)(6) 2020, A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2020, THE PATIENT UNDERWENT IR EMBOLIZATION PROCEDURE. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

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

  MAUDE report 14553823 ↗
• MalfunctionMay 25, 2022Migration; Migration

  ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT311417). FOLLOW UP IMAGING WAS PERFORMED IN (B)(6) 2020 AND (B)(6) 2021 AND IN BOTH CASES THE GRAFT LOOKED NORMAL AND IN POSITION (REFER TO ATTACHED IMAGES). ON (B)(6) 2022, FOLLOW UP IMAGING WAS AGAIN PERFORMED AND SHOWED ENDOPROSTHESIS DISTAL MIGRATION IN THE RANGE OF 1 TO 1.5CM FROM THE ORIGINAL IMPLANT LOCATION. THE CAUSE OF THE MIGRATION IS UNKNOWN. A PLAN IS ONGOING FOR PATIENT TREATMENT AND THE NEED FOR REINTERVENTION IS CURRENTLY BEING DETERMINED. AS OF (B)(6) 2022 THERE ARE NO CURRENT PLANS TO INTERVENE. IMAGES HAVE BEEN PROVIDED FOR CONSIDERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498861 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOLEAK REPAIR. INFORMATION OBTAINED FROM IMEDIDATA STUDY DATABASE REVEALED THAT BETWEEN FOLLOW UP EXAMINATIONS ON (B)(6) 2016 TO (B)(6) 2021, THE ANEURYSM INCREASED DIAMETER FROM 61 MM TO 76 MM.

  Patient problems: Aneurysm

  MAUDE report 14054912 ↗
• InjuryApr 1, 2022Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED WITH BACK PAIN. IMAGING REVEALED GRADUAL DISEASE PROGRESSION INTO THE INFRARENAL AORTA AND RESULTED IN VESSEL DILATION AND ENDOPROSTHESIS MIGRATION OF UNKNOWN LENGTH. THE PATIENT UNDERWENT REINTERVENTION AND AN AORTIC CUFF WAS IMPLANTED PROXIMAL OF THE PREVIOUSLY PLACES RLT DEVICE TO REGAIN SEAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 13982341 ↗
• MalfunctionAug 31, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ON (B)(4) 2021, DURING AN ENDOVASCULAR PROCEDURE, WHEN THE PHYSICIAN INSERTED THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM INTO A GORE® DRYSEAL 18FR SHEATH, A "POP" WAS HEARD. SHORTLY AFTER THAT, BLOOD BEGAN TO LEAK FROM THE SHEATH. THE PHYSICIAN REMOVED THE EXCLUDER® DELIVERY SYSTEM AND NOTICED A METAL WIRE PROTRUDING OUT OF THE PROXIMAL PORTION OF THE CONSTRAINED STENT GRAFT. IT APPEARED TO BE A PIECE OF NITINOL WIRE STICKING OUT BETWEEN THE OLIVE TIP AND THE STENT GRAFT. THE DEVICE AND SHEATH WERE DISPOSED OF AT THE HOSPITAL AND NOT SENT BACK FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12399441 ↗
• InjuryJul 23, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR LEFT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM, AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND THE OUTCOME WAS REPORTED TO HAVE BEEN SUCCESSFUL. ON (B)(6) 2020, FOLLOW-UP IMAGING DETERMINED A TYPE III ENDOLEAK (DISCONNECT) ON THE LEFT SIDE BETWEEN THE ILIAC BRANCH COMPONENT AND THE CONTRALATERAL LEG COMPONENT USED AS THE BRIDGE GRAFT. THE PHYSICIAN BELIEVES ELONGATION OF THE ANEURYSMAL AREA AND TORTUOSITY OF THE PATIENT'S ILIAC ARTERIES ATTRIBUTED TO THE DISCONNECT. ADDITIONALLY, ON THE RIGHT SIDE A TYPE III ENDOLEAK (DISCONNECT) WAS DETERMINED TO BE PRESENT INVOLVING THE IPSILATERAL LEG AND AN ILIAC EXTENDER COMPONENT, BELIEVED TO HAVE BEEN CAUSED FROM THE TORTUOSITY OF THE PATIENT'S ANATOMY ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND BOTH SIDES WERE RELINED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAKS WERE RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 12221801 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN), REVEALED A POSSIBLE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2021 THERE WAS A REINTERVENTION. THE PHYSICIAN BALLOONED THE PROXIMAL PORTION OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG UNDER ANGIOGRAPHY. THE ENDOLEAK WAS RESOLVED. THERE WAS NO ANEURYSM SAC ENLARGEMENT. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11930478 ↗

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