GORE EXCLUDER AAA Endoprosthesis PLC161200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132618705), received between Aug 8, 2018 and Sep 29, 2026 — classified as 1 death, 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore on September 17, 2026 from the iMedidata database: On (b)(6) 2026, a patient with abdominal aortic aneurysm (no iliac involvement) underwent primary procedure for endovascular treatment. One GORE® EXCLUDER® Conformable AAA Endoprosthesis was implanted in infrarenal abdominal aorta, two GORE® EXCLUDER® AAA Endoprosthesis were implanted in the left and right common iliac artery respectively.On (b)(6) 2026, a subtle and non-flow limiting small dissection membrane in the right and left external iliac artery was reported. The dissection is uncomplicated and not adjacent to the stent grafts. This event is listed as related to treatment/procedure, ongoing, and not caused by a Gore accessory, No treatment is required. On (b)(6) 2026, the patient was discharged from the hospital.

  Patient problems: Aortic dissection

  MAUDE report 50929833 ↗
• InjuryFeb 17, 2026Structural Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND GORE® EXCLUDER® AAA ENDOPROSTHESES (THREE PLCS). ON AN UNKNOWN LATER DATE, THE PATIENT RECEIVED IMAGING AND THE PHYSICIAN BELIEVED THE PLC LIMBS LOOKED "TENSED" AND NEEDED TO BE RE-BALLOONED. REPORTEDLY, IT IS UNKNOWN IF THE PHYSICIAN THOUGHT THE DEVICES WERE COMPRESSED FROM THE INITIAL IMPLANT; HOWEVER, THE PHYSICIAN BELIEVED THEY NEEDED TO BE EXPANDED MORE BY BALLOONING. IT WAS REPORTED THE PATIENT HAD A TIGHT AORTIC BIFURCATION AND CALCIUM AROUND THE AREA OF THE DEVICES. THE PHYSICIAN INFORMED THE GORE FIELD SALES ASSOCIATE ON (B)(6) 2026 THAT A REINTERVENTION WAS PLANNED FOR THE PATIENT TO RE-BALLOON THE LIMBS. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHERE THE PHYSICIAN BALLOONED THE LIMBS BILATERALLY AT THE DISTAL AORTIC BIFURCATION. IT IS UNKNOWN WHICH SPECIFIC PLC DEVICES WERE BALLOONED. THERE ARE NO CLINICAL IMAGES AVAILABLE. THE PATIENT HAD NO CLINICAL SEQUELAE AND THERE WERE NO OTHER ADVERSE EVENTS REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364741 ↗
• InjuryDec 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE AND IMAGING EMAIL: ON (B)(6) 2025, A PATIENT WITH ABDOMINAL AORTIC ANEURYSM (WITH NO ILIAC INVOLVEMENT) UNDERWENT AN ENDOVASCULAR PROCEDURE. PRE-PROCEDURE IMAGING MEASUREMENTS ON (B)(6) 2025 SHOWED A MAXIMUM DIAMETER OF ABDOMINAL AORTA OF 58 MM. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS IMPLANTED IN THE ABDOMINAL AORTA, THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) WAS IMPLANTED IN THE RIGHT AND LEFT COMMON ILIAC ARTERY. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2025 AND A MINOR INCREASE IN SIZE OF THE ANEURYSM SAC WAS OBSERVED. THE MAXIMUM DIAMETER OF ABDOMINAL AORTA INCREASED TO 66 MM. REVIEW BY GORE IMAGING SERVICES (GIS) ALSO INDICATED A POSSIBLE DISSECTION ADJACENT TO THE DISTAL END OF THE CONTRALATERAL LEG COMPONENT IN THE LEFT COMMON ILIAC ARTERY. THE SITE DOES NOT SHOW ANY SCHEDULED PROCEDURES PLANNED FOR THE PATIENT AT THIS TIME; THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 23901614 ↗
• InjuryDec 19, 2025Device Endoleak; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2016 THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, THE BASELINE MEASUREMENT OF THE ANEURYSM DIAMETER PERFORMED DURING COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING WAS 50 MM. ON (B)(6) 2016 FOLLOW- UP IMAGING IDENTIFIED A DISTAL TYPE 1 ENDOLEAK WITH AN ANEURYSM SAC NOW MEASURING 53 MM AND THE RELATIONSHIP WAS STATED TO BE UNRELATED TO THE DEVICE OR THE PROCEDURE. HOWEVER, BETWEEN APRIL 6, 2018 AND MAY 31, 2025, YEARLY FOLLOW-UP MEASUREMENTS WERE PERFORMED, REVEALING THAT THE ANEURYSM HAD INCREASED FROM 55 MM TO 85 MM. IT IS CURRENTLY UNKNOWN TO GORE IF A REINTERVENTION HAS BEEN CONSIDERED BY THE PHYSICIAN TO TREAT THE TYPE 1B ENDOLEAK.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Insufficient Information

  MAUDE report 23855551 ↗
• 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, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE PROCEDURE WAS A TECHNICAL SUCCESS. REPORTEDLY, SEVERAL HOURS POST PROCEDURE, THE PATIENT DEVELOPED LOWER EXTREMITY PARALYSIS. THE PHYSICIAN REINTERVENED AND PUT IN A SPINAL DRAIN. THE PARALYSIS IS ONGOING.

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

  MAUDE report 23618861 ↗
• DeathNov 6, 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 AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT WAS CONVERTED TO OPEN AND EXPLANT OF ALL THE DEVICES WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT'S AORTA WAS SEVERELY INFECTED WITH AREAS OF HARD INFECTION AND OTHER AREAS FULL OF CLEAR PUSS WHICH WAS SUCKED OUT AND REMOVED. THE PHYSICIAN WONDERED WHETER OR NOT THE PATIENT HAD A PRE-EXISING INFECTION. HE DID NOT KNOW AS THE INDEX PROCEDURE WAS PERFORMED BY ANOTHER PHYSICIAN AT A DIFFERENT HOSPITAL. POST EXPLANT OF ALL DEVICES DURING CLOSING, WHEN THE PHYSICIAN REMOVED THE CLAMP ON THE SUPER CELIAC, THE PATIENT'S BLOOD PRESSSURE TANKED AND THE PATIENT CODED. CPR WAS PERFORMED BUT THEY WERE NOT ABLE TO GET THE PATIENT BACK, HE EXPIRED DURING CLOSING. ACTUAL CAUSE OF DEATH WAS NOT KNOWN.

  Patient problems: Pyogenic Infection

  MAUDE report 23493234 ↗
• InjuryJul 31, 2025Adverse 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, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND TWO CONTRALATERAL LEGS). ON (B)(6) 2025, PHYSICIAN NOTIFIED THE FIELD SALES ASSOCIATE THAT THE PATIENT HAS AN ABSCESS AROUND THE DISTAL LEFT COMMON ILIAC ARTERY WITH A DRAIN IN-SITU PERFORMED (DATE UNKNOWN OF WHEN DRAIN WAS INSERTED). PHYSICIAN WILL EXPLORE SURGICALLY AND PLANS FOR POSSIBLE EXPLANT OF THE EXCLUDER LIMB FROM THE LEFT SIDE AND CONVERT THE TRUNK IPSILATERAL LEG TO UNIBODY GRAFT. THERE ARE NO REPORTED ISSUES WITH THE TRUNK IPSILATERAL LEG. CAUSE OF THE ABSCESS IS CURRENTLY UNKNOWN AND ALSO, IT IS CURRENTLY UNKNOWN IF PHYSICIAN HAS PERFORMED A SURGICAL EXPLANT OF THE LEFT CONTRALATERAL LIMB OR WILL DO SO IN THE FUTURE.

  Patient problems: Abscess

  MAUDE report 22679077 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 100MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6) 2015 TO (B)(6), 2019, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED FROM 98MM TO 65MM. THE FOLLOW UP CTA SHOWED THAT FROM (B)(6), 2020 TO (B)(6) 2022, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 66MM TO 83MM. ON (B)(6) 2021, A CONSISTENT GROWTH OF THE ANEURYSM SAC WITHOUT IDENTIFIABLE SOURCE OF ENDOLEAK WAS REPORTED. ACCORDING TO THE SITE, THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. ON (B)(6) 2021 AN ILIAC ANGIOGRAM WAS PERFORMED. NO DISCERNIBLE ENDOLEAK WAS FOUND. THE PHYSICIAN RECOMMEND AN OPEN REPAIR OF THE ANEURYSM TO PREVENT RUPTURE AND POSSIBLY DEATH. THE PATIENT REFUSED TO DO ANY ADDITIONAL PROCEDURES. THE FOLLOW UP CTA SHOWED THAT ON (B)(6) 2024, THE AORTIC ANEURY

  Patient problems: Aneurysm expansion

  MAUDE report 22172530 ↗
• InjuryApr 3, 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® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A ¿SHORT¿ AORTIC NECK. IT WAS REPORTED THAT ALL DEVICES WERE IMPLANTED BUT THERE WAS NOT A GOOD SEAL AT THE PROXIMAL AORTIC NECK, DUE TO AORTIC NECK ANATOMY. THE PHYSICIAN CHOSE TO EXPLANT THE IMPLANTED DEVICES AND CONVERTED TO AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21767735 ↗
• MalfunctionFeb 5, 2025Break; Break

  ON (B)(6) 2025, DURING AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF AN ENDOLEAK ASSOCIATED WITH A PREVIOUSLY IMPLANTED MEDTRONIC GRAFT, A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS ADVANCED WITHIN THE PATIENT. POST DEPLOYMENT OF THE DEVICE WHEN REMOVING THE CATHETER THROUGH THE SHEATH, THE CATHETER BROKE APPROXIMATELY 7-8CM DOWN. THERE WAS NO COMPROMISE TO THE PATIENT. THE BROKEN CATHETER PORTION AND THE OLIVE TIP WERE SNARED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. IT WAS REPORTED THERE HAD BEEN SOME TORTUOSITY, AND THE PHYSICIAN HAD EXPERIENCED SOME RESISTANCE WHEN REMOVING THE DEVICE. THE CAUSE FOR THE BREAKAGE IS NOT KNOWN HOWEVER OVERINFLATION OF THE BLADDER OF THE DRYSEAL SHEATH; OR TOO MUCH FORCE DURING REMOVAL (CAUSING THE CATHETER TO "SNAP") MAY HAVE CONTRIBUTED TO THE BREAKAGE.

  Patient problems: Clinical Endoleak

  MAUDE report 21314464 ↗
• InjuryNov 25, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (TENT GRAFT TRUNK IPSILATERAL LEG C3 AND STENT GRAFT CONTRALATERAL LEG) ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS A SUSPECTED DISTAL TYPE I ENDOLEAK TO THE PREEXISTING DEVICE IN PLACE. IT WAS TOO DIFFICULT CONFIRM IT ANGIOGRAPHICALLY. A REINTERVENTION WAS PERFORMED. 2 CONTRALATERAL LEGS (PLC201000 AND PLC231200) WERE IMPLANTED ON EACH SIDE OF THE PATIENT. THE PHYSICIAN WANTED TO EXTEND BILATERALLY TO ENSURE THERE WAS AS MUCH SEAL AS POSSIBLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20774126 ↗
• InjuryOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT IMAGING WHICH DETERMINED A POSSIBLE ENDOLEAK. ON (B)(6) 2024, IMAGES WERE PROVIDED TO GORE IMAGING SERVICES FOR EVALUATION OF A POSSIBLE ENDOLEAK. THE RESULTS OF THE IMAGING EVALUATION DETERMINED THE FOLLOWING: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2024. CONTRAST OUTSIDE THE IMPLANTED DEVICES CAN BE VISUALIZED ~4CM DISTAL TO THE LEFT RENAL ARTERY. THERE APPEARS TO BE CONTRAST OUTSIDE THE CONTRALATERAL LEG THAT EXTENDS INTO THE LCI AT A HIGHLY ANGULATED VESSEL ORIGIN. THIS CONTRAST COMMUNICATES WITH CONTRAST POOLING IN THE ANEURYSM SAC. O CANNOT IDENTIFY A DEVICE DISCONNECTION/SEPARATION. O CANNOT IDENTIFY A TYPE II ENDOLEAK. O POSSIBLE TYPE III, HOLE IN THE GRAFT, AT THE LEVEL OF THE ANGULATED LCI ORIGIN (PLC161200/(B)(6)). O ENDOLEAK CONFIRMED, OF UNKNOWN ORIGIN WITH AVAILABLE IMAGING. ON (B)(6) 2024, IT WAS REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466995 ↗
• MalfunctionSep 17, 2024Break; Break

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES IN ZONE 9. IT WAS REPORTED THAT THE DELIVERY CATHETER WAS IN PLACE. THE PHYSICIAN ATTEMPTED TO LOOSEN THE DEPLOYMENT KNOB AND THE DEPLOYMENT KNOB IMMEDIATELY FELL OFF. THE FSA SUGGESTED THAT THE PHYSICIAN ACQUIRE A PAIR OF HEMOSTATS TO GRAB THE DEPLOYMENT LINE; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE DEVICE WAS NEVER DEPLOYED SO THE PHYSICIAN DECIDED TO PULL THE DEVICE OUT AND USE A NEW GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC) TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241379 ↗
• MalfunctionMay 3, 2024Premature Activation; Self-Activation or Keying; Device-Device Incompatibility; Migration; Premature Activation; Self-Activation or Keying; Device-Device Incompatibility; Migration

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC161200) WAS USED TO TREAT AN EMERGENCY CASE WHERE A PATIENT WHO HAD A ANEURYSM RUPTURE (CAUSED BY A TYPE 1A ENDOLOEAK ON AN (UNKNOWN) STENTGRAFT ALREADY IN PLACE). WHILE INTRODUCING THE DEVICE TO THE DEPLOYMENT SITE, THE PROTECTIVE SLEEVE CONSTRAINING THE DEVICE OPENED UNINTENTIONALLY AND MIGRATED UPWARDS THE DESIRED IMPLANTATION SITE (WHILE INSIDE THE MAIN GRAFT BODY). AN ATTEMPT WAS MADE TO SNARE THE DEVICE WITHOUT SUCCESS, AS THE DEVICE WAS ALREADY OPEN. IT WAS ADDITIONALLY REPORTED, THAT THE ENDOPROSTHETIC SURGERY WAS COMPLICATED BY AN EARLY POSTOPERATIVE HEMORRHAGIC SHOCK UNRELATED TO THIS REPORTED INCIDENT, REQUIRING IMMEDIATE SURGICAL REVISION REVEALING INTRA-ABDOMINAL BLEEDING BEYOND ANY THERAPEUTIC RESOURCE. IT WAS CONFIRMED THAT THIS INCIDENT DID NOT LEAD TO THE PATIENT'S DEATH ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19238039 ↗
• InjuryMar 21, 2024Adverse 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) 2024, 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 ON (B)(6) 2024, ALL THREE GORE DEVICES WERE EXPLANTED DUE TO INFECTION. AN OPEN REPAIR WAS THEN PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICES WERE CULTURED AT HOSPITAL AFTER EXPLANT AND SALMONELLA WAS THE CAUSE OF THE INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 18949533 ↗
• 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,

  Patient problems: Aneurysm expansion

  MAUDE report 17409792 ↗
• InjuryFeb 14, 2023Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  ON (B)(6), 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, BILATERAL TYPE I DISTAL ENDOLEAKS WERE REPORTED FOR THE PATIENT. THE ENDOLEAKS WERE IDENTIFIED WITHIN THE CONTRALATERAL LEG COMPONENTS. THE PHYSICIAN PLANNED TO REINTERVENE ON (B)(6), 2023 AND IMPLANT BI-LATERAL EXTENSIONS AND EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY. IT WAS LATER REPORTED THAT ON (B)(6), 2023, THE PHYSICIAN PERFORMED REINTERVENTION SURGERY IN WHICH BI-LATERAL EXTENSIONS WERE IMPLANTED AND THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16376444 ↗
• InjuryMay 13, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, 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 FOLLOW UP IMAGES, (COMPUTED TOMOGRAPHY DATED (B)(6) 2022), REVEALED BOTH LIMBS OF DEVICES BILATERALLY WERE COMPRESSED. THERE WAS SOME FLOW AND THE PATIENT PRESENTED NONSYMPTOMATIC. REPORTEDLY DURING THE ORIGINAL PROCEDURE, ¿THE DISTAL AORTA WAS SMALL¿. ON (B)(6) 2022, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES INSIDE EACH GORE® EXCLUDER® AAA ENDOPROSTHESES LIMB. THIS OPENED THE COMPRESSION. THE PATIENT TOLERATED THE PROCEDURE. ROOT CAUSE OF COMPRESSION- DURING THE ORIGINAL PROCEDURE, ¿THE DISTAL AORTA WAS SMALL¿.

  Patient problems: Aneurysm

  MAUDE report 14398279 ↗
• InjurySep 20, 2021Adverse 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) 2020 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM IN THE (B)(6) STUDY. THE PROCEDURE INCLUDED THE USE OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2021 FOLLOW-UP IMAGING REVEALED A NEW DISSECTION AT THE DISTAL END OF THE IPSILATERAL ILIAC EXTENDER IN THE RIGHT COMMON ILIAC ARTERY. UPON FURTHER INVESTIGATION THE DISSECTION WAS REPORTED TO BE IMMEDIATELY ADJACENT TO THE DEVICE AND NO REINTERVENTION IS PLANNED.

  Patient problems: Vascular Dissection

  MAUDE report 12502950 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2021, THE PATIENT REMAINED HOSPITALIZED. IT WAS REPORTED THE PATIENT IS IMPROVING WITH SENSATION IN THE BILATERAL EXTREMITIES, NO MOVEMENT, AND PULSES PALPABLE BILATERALLY.

  Patient problems: Paraplegia

  MAUDE report 11750103 ↗
• InjuryApr 17, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6), 2018, AND DUE TO THE OBSERVED ANEURYSM GROWTH, A RE-INTERVENTION WAS PERFORMED AND AN ADDITIONAL GORE® EXCLUDER® ENDOPROSTHESIS WAS PREVENTIVELY IMPLANTED AS AN EXTENSION INTO THE RIGHT EXTERNAL ILIAC ARTERY. HOWEVER, LATER THAT DAY, THE PATIENT BECAME HYPOTONIC AND CT IMAGING SHOWED A BLEEDING ORIGINATING FROM THE RIGHT COMMON ILIAC ARTERY DUE TO AN INJURY THAT HAD OCCURRED DURING THE IMPLANT PROCEDURE. TO REMEDY THE SITUATION, ANOTHER STENTGRAFT WAS PLACED INTO THE EXTERNAL ILIAC ARTERY AS AN EXTENSION AND THE RIGHT INTERNAL ILIAC ARTERY WAS PLUGGED.

  Patient problems: No Code Available

  MAUDE report 8524768 ↗
• MalfunctionSep 4, 2018Premature Activation; Improper or Incorrect Procedure or Method; Difficult to Advance; Premature Activation; Improper or Incorrect Procedure or Method; Difficult to Advance

  ON (B)(6) 2018, A LOW-PROFILE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT (PLC161000/(B)(4)) WAS TO BE IMPLANTED AS PART OF AN ENDOVASCULAR REPAIR OF AN ILIAC AND HYPOGASTRIC ARTERY ANEURYSM. THE PATIENT¿S ANATOMY REPORTEDLY FEATURED MODERATE TORTUOSITY. ACCORDING TO THE REPORT, THE PHYSICIAN OPTED TO USE THE CONTRALATERAL LEG COMPONENT IN PLACE OF A STANDARD EXCLUDER® INTERNAL ILIAC COMPONENT DUE TO THE SIZE OF THE PATIENT¿S HYPOGASTRIC ARTERY (MEASUREMENT NOT AVAILABLE). THE PHYSICIAN REPORTEDLY HAD DIFFICULTY ADVANCING THE CONTRALATERAL LEG COMPONENT ON THE GUIDEWIRE OVER THE AORTIC BIFURCATION TO THE HYPOGASTRIC ARTERY. IT WAS REPORTED THAT THE LEADING OLIVE APPEARED TO HAVE SEPARATED FROM THE DELIVERY CATHETER ON INTRA-PROCEDURAL IMAGING. THE DEVICE WAS WITHDRAWN BACK INTO THE INTRODUCER SHEATH, AND IT WAS REPORTEDLY NOTED THAT THE OLIVE HAD NOT SEPARATED FROM THE CATHETER. HOWEVER, THE REPORT STATES THE DEVICE BEGAN TO DEPLOY FROM THE TRAILING END AS IT WAS REMOVED FROM THE SHEATH. THE DELIVERY CATHETER AND INTRODUCER SHEATH WERE REMOVED FROM THE PATIENT. ANOTHER SHEATH AND A STANDARD EXCLUDER® INTERNAL ILIAC COMPONENT WERE USED TO CONTINUE THE CASE. THE PROCEDURE WENT FORWAR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843232 ↗
• InjuryAug 11, 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) 2018 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE DEVICE SEALED PROXIMALLY, DISTALLY AND IN OVERLAP AREAS AT THE END OF THE PROCEDURE. ON (B)(6) 2018 THE PATIENT HAD A REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK, WHEREBY AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED.

  Patient problems: Aneurysm

  MAUDE report 7775357 ↗
• InjuryAug 8, 2018Expulsion; Expulsion

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES IN AN EMERGENCY PROCEDURE. ON (B)(6) 2018, A TYPE III ENDOLEAK ON THE PATIENTS LEFT WAS DISCOVERED DUE TO INSUFFICIENT OVERLAP BETWEEN TWO CONTRALATERAL LEG ENDOPROSTHESES. IT WAS ALSO STATED THAT THE ANEURYSM DIAMETER INCREASED FROM 82-83MM TO 84MM. ON (B)(6) 2018, A REINTERVENTION WAS SUCCESSFULLY PERFORMED BY RELINING THE SEPARATED COMPONENTS WITH AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS.

  Patient problems: Aneurysm

  MAUDE report 7760893 ↗

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