GORE EXCLUDER AAA Endoprosthesis PLL161407Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00733132618767), received between Jul 3, 2018 and May 5, 2026 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5, 2026Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE-9 INFRARENAL ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, AN ILIAC EXTENDER (PLL) WAS MALPOSITIONED, RESULTING IN UNINTENTIONAL COVERAGE OF THE RIGHT INTERNAL ILIAC ARTERY. THE REPORTER STATED THAT THIS OCCURRED WHILE FLUOROSCOPIC IMAGING WAS MAGNIFIED, WHICH LIMITED VISUALIZATION OF THE TRUE DISTAL RADIOPAQUE MARKER ON THE ILIAC EXTENDER. UNDER MAGNIFIED FLUOROSCOPY, A RADIOPAQUE MARKER INTENDED TO INDICATE THE MINIMUM REQUIRED PROXIMAL OVERLAP WAS MISTAKENLY IDENTIFIED AS THE DISTAL END MARKER. AS A RESULT, THE DEVICE WAS DEPLOYED MORE DISTALLY THAN INTENDED. THE ISSUE WAS RECOGNIZED AFTER DEPLOYMENT DURING BALLOONING, WHEN THE DISTAL END OF THE ILIAC EXTENDER WAS OBSERVED TO EXTEND INTO THE EXTERNAL ILIAC ARTERY. AT THAT TIME, THE DEVICE WAS FULLY DEPLOYED AND COULD NOT BE REPOSITIONED. THE RIGHT INTERNAL ILIAC ARTERY WAS COVERED WITHOUT EMBOLIZATION; NO COILS OR ADDITIONAL PROCEDURES WERE PERFORMED TO OCCLUDE THE VESSEL. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE COVERAGE. THE LEFT INTERNAL ILIAC ARTERY WAS WIDELY PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086851 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, DURING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY ACCESSING THE RIGHT RENAL ARTERY. DESPITE ATTEMPTS, THE ARTERY COULD NOT BE CANNULATED. AS A RESULT, THE PHYSICIAN ELECTED TO PLUG THE RENAL PORTAL WITH AN AMPLATZER 14 MM PLUG. THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS RELATED TO THE GORE DEVICE(S). NO RENAL COMPLICATIONS WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE ON (B)(6) 2026, THE PATIENT DEVELOPED PARAPARESIS. A RESCUE SPINAL DRAIN WAS PLACED, AFTER WHICH THE PATIENT BEGAN SLOWLY IMPROVING.

  Patient problems: Paresis

  MAUDE report 24598101 ↗
• InjuryOct 29, 2025Microbial Contamination of Device; Patient Device Interaction Problem; Microbial Contamination of Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE ON OCTOBER 16, 2025, FROM THE IMEDIDATA STUDY DATABASE AND IMAGING EMAIL: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE®¿EXCLUDER®¿CONFORMABLE AAA ENDOPROSTHESIS DEVICE AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE GORE® DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED INFECTION RELATED TO GORE® EXCLUDER® DEVICES. REPORTEDLY, SALMONELLA SPECIES WAS THE ISOLATED MICROORGANISM IN ALL HIS MICROBIOLOGIC SPECIMENS. THE PATIENT HAD A MEDICATION TREATMENT USING CEFTRIAXONE 2G DAILY. ADDITIONALLY, THE PATIENT HAD IV BLOOD TEST AND A CTA. THE SCAN REVEALED THE INCREASING INFLAMMATORY CHANGES AROUND THE AORTIC STENTS. ALL THREE DEVICES WERE INFECTED. REPAIR WITH A SMALL ABSCESS COLLECTION FORMING WITHIN THIS. ON (B)(6) 2025, ALL DEVICES WERE EXPLANTED AND RIGHT AXILLARY BIFEMORAL GRAFT (OPEN SURGERY) WAS USED. NO NEW GORE DEVICES WERE IMPLANTED. THE PATIENT COMPLETED THE STUDY. THE PATIENT WAS DISCHARGED FROM THE CRITICAL CARE ON (B)(6) 2025, AND IS STABLE, R

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 23420842 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6) 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 57MM, AND A PROXIMAL LANDING ZONE WITH A MAXIMUM DIAMETER OF 27MM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO (HOME- SELF-CARE) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) THAT DETERMINED A NEW DISSECTION IN THE DISTAL RIGHT EXTERNAL ILIAC ARTERY. PRE-PROCEDURE CTA DETERMINED THE PATIENT¿S RIGHT COMMON FEMORAL ARTERY DIAMETER MEASURED 7MM AND THE MAXIMUM DIAMETER OF THE RIGHT COMMON ILIAC ARTERY (RCIA) MEASURED 10MM. THE INTENDED EXTERNAL ILIAC ARTERY (EIA) VESSEL DIAMETER FOR THE GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS (PLL161407/(B)(6) IMPLANTED IN THE REIA IS 22-13.5MM WITH THE INTENDED VESSEL DIAMETER ON THE ILIAC END BEING 14.5MM. THERE ARE NO SCHEDULED PROCEDURES PLANNED FOR THE PATIENT AT THIS TIME; THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 22868376 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO TREAT ANEURYSM ENLARGEMENT FOR AN UNDETERMINED ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN EXPLANTED ALL DEVICES DUE TO AN INFLAMMATORY ANEURYSM (POSSIBLY INFECTED BUT CULTURES CAME BACK NEGATIVE) AND FOR A PROXIMAL TYPE I ENDOLEAK. ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN PERFORMED AN OPEN CONVERSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22637879 ↗
• InjuryJun 4, 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 WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BACK AND CHEST PAIN. IMAGES REVEALED INFECTED GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PHYSICIAN EXPLANTED ALL THREE IMPLANTED DEVICES. AN OPEN REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, WHEN THE PATIENT WAS IMPLANTED, THERE WAS NO INFECTION.

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

  MAUDE report 22140581 ↗
• InjuryMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESES IN ZONE 9. THE PROCEDURE WAS UNEVENTFUL WITH SUCCESSFUL EXCLUSION OF AAA. THE ANEURYSM WAS SEALED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON POST OPERATION DAY 1, THE PATIENT WAS FOUND TO HAVE NO RIGHT LOWER EXTREMITY PULSE POST EVAR APPROXIMATELY 1 TO 2 HOURS IN RECOVERY. A DRY SEAL HYDRO FLEX SHEATH WAS USED ON RIGHT SIDE. PHYSICIAN THEORIZED THAT POSSIBLE MANUAL COMPRESSION TO ASSIST HEMOSTASIS DURING CLOSURE DEVICE DEPLOYMENT IN CONJUNCTION WITH PROTAMINE USAGE CAUSED FRESH CLOT TO FORM AND EVENTUAL EMBOLIZATION. THE PATIENT WAS TAKEN BACK TO THE OR FOR A SUBSEQUENT IMMEDIATE OR OPEN GROIN EXPLORATION WITH CLOT REMOVAL. A THROMBOTIC AGENT WAS INFUSED TO FACILITATE DISTAL TIBIAL VESSEL CLOT BREAKDOWN AS WELL AS DEVICE THROMBECTOMY USAGE PLANNED POST OPERATION DAY 1. THE HOSPITAL DID NOT HAVE THE NECESSARY EQUIPMENT TO FULLY ASSESS THE PATIENT'S CONDITION, THEREFORE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS NOTED THE PATIENT HAS HAD DIMINISHED PULSES IN HIS FEE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21566101 ↗
• InjuryFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6)2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, TO TREAT AN ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351414 AND PLL161407) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (TGMR404010) WAS ALSO IMPLANTED PROXIMALLY AS WELL. ON (B)(6) 2025, PATIENT PRESENTED WITH A RUPTURED ANEURYSM. AN TYPE 1A ENDOLEAK WAS ALSO IDENTIFIED ON TGMR404010 DEVICE. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION SURGERY IN WHICH EXCLUDER CONFORMABLE AORTIC EXTENDERS WERE IMPLANTED. PHYSICIAN COVERED THE RENALS WITH AORTIC EXTENDERS INTO THE PREVIOUS TRUNK. NO ENDOLEAK WAS NOTED AFTER THE PROCEDURE. THE EXACT LOCATION OF RUPTURE IS UNKNOWN. PHYSICIAN DOES NOT KNOW WHAT CAUSED THE RUPTURE, BUT BELIEVES IT WAS A RESULT FROM PROXIMAL TYPE 1A ENDOLEAK. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21299069 ↗
• InjuryDec 5, 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) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR ANEURYSM RUPTURE UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND ILIAC EXTENDER). ON(B)(6) 2024, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT HAS INFECTED ENDOGRAFTS AND IS BEING TRANSFERRED TO AN OTHER INSTITUTION FOR TREATMENT. AT TIME, INFORMATION IS NOT AVAILABLE IF PHYSICIAN PLANS TO EXPLANT THE DEVICES OR NEXT STEP OF TREATMENT. ON NOVEMBER 19, 2024, ADDITIONAL INFORMATION RECEIVED: CAUSE OF INFECTION IS UNKNOWN AND AN EXPLANT PROCEDURE WAS DONE ON AN UNKNOWN DATE AND IT IS UNKNOWN IF ONE OR ALL 3 DEVICES WERE EXPLANTED. PATIENT IS DOING WELL AFTER THE EXPLANT PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20858447 ↗
• MalfunctionJul 9, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE PHYSICIAN PREPARED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR IMPLANT. DIFFICULTY WAS EXPERIENCED WHILE ATTEMPTING TO REMOVE THE PACKAGING MANDREL FROM THE DEVICE, AND WHEN IT WAS FINALLY REMOVED, IT ALSO BROKE OFF PART OF THE DELIVERY CATHETER LEADING OLIVE. THIS WAS NOT NOTICED BY THE PHYSICIAN, AND THE DEVICE WAS INSERTED INTO A GORE® DRYSEAL FLEX SHEATH. NO UNUSUAL RESISTANCE WAS FELT AS THE DEVICE WAS ADVANCED INTO THE SHEATH, BUT THE SHARP END OF THE BROKEN LEADING OLIVE CUT THE VALVE OF THE SHEATH, RESULTING IN MINOR BLEEDING. ESTIMATED BLOOD LOSS WAS 100ML, NO BLOOD PRODUCTS GIVEN. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER AND MANDREL WILL BE RETURNED FOR EVALUATION. THE FSA HAD NO INFORMATION ON THE SHEATH, AND IT WAS DISCARDED AT THE FACILITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19701854 ↗
• InjuryJul 3, 2024Adverse 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 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT DURING IMPLANT OF THE GORE® EXCLUDER® ILIAC BRANCH COMPONENT THE DEVICE WAS ALMOST COMPLETELY PULLED OUT OF THE 3CM OVERLAP ZONE DURING REMOVAL OF THE DEVICE DELIVERY SYSTEM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WAS IMPLANTED TO BRIDGE ANY GAP AND RELINE THE AREA. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE USED AS BRANCH DEVICES IN THE SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, RIGHT AND LEFT RENAL ARTERIES. A GORE® TRI LUMEN CATHETER WAS USED TO GAIN THROUGH AND THROUGH WIRE ACCESS TO THE BRANCH ARTERIES. THE PROCEDURE WAS COMPLETED WITH GOOD TECHNICAL RESULTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT AWOKE AND HAD NO FEELING IN HIS LEGS. THE PATIENT UNDERWENT PLACEMENT OF A SPINAL DRAIN. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE PARAPLEGIA. THE PATIENT IS BEING MONITORED IN THE INTENSIVE CARE UNIT (ICU) AND WAS REPORTED TO HAVE STARTED REGAINING MOVEMENT IN HIS RIGHT LEG AN

  Patient problems: Paraplegia

  MAUDE report 19672059 ↗
• InjuryJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDE® CONFORMABLE AAA ENDOPROSTHESES, (CXT231412/27655726) THE RIGHT-SIDE CONTRALATERAL GATE WAS CANNULATED AND IMPLANTED WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC141400/26957820). ADDITIONALLY, THE RIGHT INTERNAL ILIAC ARTERY (RIIA) WAS COIL EMBOLIZED AND AN ILIAC EXTENDER ENDOPROSTHESIS (PLL161407/24050302) WAS IMPLANTED TO EXTEND COVERAGE DOWN WITH INTENTIONAL COVERAGE OF THE RIIA. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION FOR TREATMENT OF DISTAL TYPE I ENDOLEAKS ON THE RIGHT SIDE. THE PHYSICIAN REPORTED DISTAL TYPE I ENDOLEAKS OUTSIDE THE DISTAL END OF BOTH THE CONTRALATERAL LEG AND THE EXTENSION DEVICE (NOT BETWEEN THEM OUTSIDE THEM). A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED TO RELINE AND EXTEND COVERAGE IN THE COMMON ILIAC ARTERY. THE TYPE I ENDOLEAKS WERE RESOLVED, BUT IN THE PROCESS OF PUTTING A STIFF WIRE UP THE CONTRALATERAL LIMB, THE PLC141400 BECAME SEPARATED FROM THE CONTRALATERAL GATE OF THE DEVICE OF THE MAIN BODY, C

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

  MAUDE report 19580132 ↗
• InjuryFeb 23, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT361414), AND A NUMBER OF GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC141000 AND PLL161407 ON THE LEFT, PLC201000 ON THE RIGHT) WAS USED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE IMPLANT OF THE CXT361414, A MISUNDERSTANDING OF THE POSITION OF A GUIDE WIRE LED TO A WRONG MARKING OF THE POSITION OF THE LEFT INTERNAL ILIAC ARTERY. AS A RESULT, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER PLL161407) LANDED IN THE EXTERNAL ILIAC ARTERY AND COVERED THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT WAS OBSERVED FOR BUTTOCK CLAUDICATION WITHOUT ANY INDICATION OF IT 5 DAYS POST-IMPLANT. POST-OPERATION CT STILL SHOWED FLOW ON THE LEFT INTERNAL ILIAC ARTERY WHICH IS ASSUMED TO BE CLOSED SOON BY THE PHYSICIAN. NO FURTHER SURGICAL OR ENDOVASCULAR PROCEDURE IS PLANNED FOR THE PARTIALLY BLOCKED LEFT INTERNAL ILIAC ARTERY.

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

  MAUDE report 18767545 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023 PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH AN INITIAL IMPLANT OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (SN#(B)(6)) IN ZONE 2 LEFT COMMON CAROTID (LCC) TO TREAT A TYPE B DISSECTION W/ MALPERFUSION. THE CTAGAC WAS UP TO THE LEVEL OF THE LEFT COMMON CAROTID ARTERY WITH A CHIMNEY (GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS -11MMX 39MM) STENT IN THE LEFT SUBCLAVIAN ARTERY (LSA) THAT RESOLVED THE FENESTRATION AND THE TYPE B DISSECTION. THE FALSE LUMEN WAS NOT PRESSURIZED. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO A TYPE 1A ENDOLEAK INTO THE FENESTRATION NOW BETWEEN THE LEFT SUBCLAVIAN ARTERY (VBX CHIMNEY STENT) AND THE PREVIOUS GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (SN#(B)(6) ) IN THE DESCENDING AORTA THAT WAS LEAKING FROM AROUND THE GRAFT AND THE LEFT SUBCLAVIAN ARTERY AS IT APPEARED THE VBX PULLED OUT OF THE LSA. THEY PUT IN THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) FIRST THEN A GORE® EXCLUDER® AAA ENDOPROSTHESIS (SN#(B)(6) PLL- ILIAC EXTENDER) TO EXTEND DISTALLY, WHICH

  Patient problems: Clinical Endoleak; Vascular Dissection

  MAUDE report 17863378 ↗
• InjuryJul 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM REPAIR UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT TRUNK IPSILATERAL LEG C3, STENT GRAFT CONTRALATERAL LEG, AND STENT GRAFT ILIAC EXTENDER). A WEEK BEFORE PRESENTING TO EMERGENCY ROOM (DATE UNKNOWN), THE PATIENT PRESENTED FOR LEFT FLANK PAIN. PATIENT HAD CT SCAN AT THE TIME WHICH DEMONSTRATED A LARGE TYPE 1A ENDOLEAK (GROWTH SIZE UNKNOWN). PATIENT WAS SCHEDULE TO SEE THE PHYSICIAN THE SAME DAY AND BE SCHEDULED FOR URGENT OPEN ANEURYSM REPAIR BUT PATIENT NEVER ARRIVED FOR THE CLINIC VISIT. ON (B)(6) 2023, THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) FOR A URGENT FOLLOW-UP AND ADMISSION AFTER RECURRENT CHEST PAIN FOR THE LAST 3 DAYS RADIATING DOWN THE LEFT ARM. PATIENT WAS ON ASPIRIN AND NITROGLYCERIN AND HAS TENDERNESS OVER THE PALPABLE ANEURYSM SAC AND POTENTIAL ASYMPTOMATIC ANEURYSM. ITS BEEN PERSISTENT BUT NOT WORSENING OVER THE PAST 2 WEEKS AND AN OPEN REPAIR WILL BE NEEDED TO TREAT THE TYPE 1A ENDOLEAK OF AORTIC GRAFT AND ALONG WITH CARDIAC WORK-UP DONE IN ER FOR CHEST PAIN AND SURGERY PLANNED WITHIN 1-2 DAYS. ON (B)(6) 2023, TH

  Patient problems: Aneurysm expansion

  MAUDE report 17409752 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE): ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® CONTRALATERAL LEG ENDOPROSTHESES, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED THAT ON (B)(6) 2020, IMAGES REVEALED A TYPE IC ENDOLEAK. THE TYPE IC ENDOLEAK IDENTIFIED ON 1 MONTH DUPLEX US AND CTA SCAN. PATIENT SCHEDULED FOR REINTERVENTION SURGERY WITH DR. (B)(6) TO TREAT THE TYPE IC ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 14795226 ↗
• InjurySep 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK NOTED ON THE ILIAC EXTENDER COMPONENT LOCATED IN THE PATIENT'S LEFT COMMON ILIAC ARTERY. THE ENDOLEAK WAS REPORTEDLY FEEDING THE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT'S LEFT COMMON ILIAC ARTERY WAS SHORT, AND THE DEVICE DID NOT HAVE SUFFICIENT SEAL DISTALLY. IT WAS ALSO REPORTED THAT, DUE TO THE PATIENT'S COLLAGEN VASCULAR DISORDER, THE DIAMETER OF THE PATIENT'S LEFT COMMON ILIAC ARTERY HAD CONTINUED TO ENLARGE. THE ILIAC EXTENDER COMPONENT ON THE PATIENT'S LEFT SIDE WAS EXTENDED USING A CONTRALATERAL LEG COMPONENT. THE LIMB WAS EXTENDED INTO THE PATIENT'S EXTERNAL ILIAC ARTERY. AN 11X79 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS PLACED IN THE PATIENT'S LEFT INTERNAL ILIAC ARTERY USING A KISSING TECHNIQUE (PARTIAL PARALLEL DEPLOYMENT OF TWO STENT GRAFTS WITHIN A BIFURCATED VESSEL) TO PRESERVE THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10496104 ↗
• MalfunctionSep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT WAS REPORTED THAT AFTER THE PHYSICIAN INTRODUCED THE GORE® EXCLUDER® ENDOPROSTHESIS (PLL161407/ 18801183) THROUGH THE DRYSEAL FLEX SHEATH, THE SHEATH THEN CAME PARTIALLY OUT OF THE PATIENT. THIS CAUSED THE PHYSICIAN TO BE UNABLE TO DELIVER THE DELIVERY CATHETER WHERE IT NEEDED TO BE PLACED FOR DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SHEATH IN PLACE AND THE DELIVERY CATHETER WAS RETRACTED FIRST. WHEN THE DELIVERY CATHETER WAS RETRACTED TO ADVANCE THE SHEATH BACK INTO PLACE, THE OLIVE SEPARATED FROM THE DELIVERY CATHETER. THE OLIVE WAS SNARED. A NEW DEVICE WAS USED FOR THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9119032 ↗
• InjuryJul 26, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, DUE TO THE TORTUOUS ANATOMY, TWO BACK-UP MAIER WIRES WERE INTRODUCED AT THE CONTRALATERAL SIDE TO STRAIGHTEN THE ANATOMY. AFTER THE DEPLOYMENT OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS, THE CANNULATION OF THE CONTRALATERAL GATE WAS SUCCESSFULLY PERFORMED. HOWEVER, AFTER THE PLACING OF THE PLANNED GORE® EXCLUDER® AAA ENDOPROSTHESIS AT THE CONTRALATERAL SIDE, THE PROXIMAL LIMB APPEARED NOT INSIDE THE CONTRALATERAL GATE. ACCORDING TO THE INFORMATION PROVIDED, THE PHYSICIANS USED THE WRONG GUIDEWIRE TO INTRODUCE THE PROSTHESIS AND IT CAUSED THE DEPLOYMENT OF THE LIMB OUTSIDE THE GATE. A SECOND TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS INTRODUCED CHANGING THE TREATMENT INTO AN AORTO-UNI-ILIAC (AUI) PROCEDURE. REPORTEDLY, THERE WAS AN ENDOLEAK BUT IT WAS SOLVED BY DOING THE AUI PROCEDURE. THE LIMBS AT THE CONTRA-LATERAL SIDE, WERE OCCLUDED USING AN OCCLUDER PLUG AND A FEMOROFEMORAL CROSSOVER BYPASS PROCEDURE WAS PERFORMED. AT THE END OF THE OR THE PATIENT WAS DOING FINE WITH ALL VESSELS PATE

  Patient problems: Aneurysm

  MAUDE report 8834227 ↗
• InjuryDec 18, 2018Migration; Migration

  ON (B)(6) 2018, THIS PATIENT UNDERWENT AN OFFICE BASED ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PLACEMENT OF ONE OF THE ILIAC EXTENDER COMPONENTS IN THE COMMON ILIAC ARTERY, THE DEVICE INADVERTENTLY MIGRATED PROXIMALLY. THE PATIENT WAS THEN TRANSFERRED TO THE HOSPITAL AND DURING THE ATTEMPTED RELINING OF THE AORTA AND LEFT COMMON ILIAC THE PROXIMAL ILIAC EXTENDER COMPONENT WAS DEPLOYED ABOVE THE LEVEL OF THE RENAL ARTERIES, SUPERIOR MESENTERIC ARTERY AND CELIAC ARTERY. THE DECISION TO OPEN THE PATIENT AND EXPLANT THE DEVICES WAS MADE. ALL THREE COMPONENTS WERE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174024 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED LEFT SUBCLAVIAN ARTERY ANERUSYM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. LATER THIS SAME DAY THE PATIENT BECAME UNSTABLE AND WAS BROUGHT BACK INTO THE OPERATING ROOM DUE TO THE OCCURRENCE OF A NEW RUPTURE. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND THE DEVICES WERE EXPLANTED THIS SAME DAY. THE DEVICES WERE DISCARDED AT THE SITE. THERE WAS DEFICIENCY OF THE DEVICES REPORTED. THE PATIENT TOLERATED THE PROCEDURE AND HAS FOLLOW UP SCHEDULED FOR (B)(6) 2018 WITH THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658178 ↗

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)