GORE EXCLUDER AAA Endoprosthesis PXL161407Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132610082), received between Sep 11, 2018 and Dec 18, 2023 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathDec 18, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  ON (B)(6) 2014, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 79.1MM IN DIAMETER AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 78.9MM. ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT REINTERVENTION FOR AN OCCLUDED GORE TRUNK IPSILATERAL LEG ON (RLT261412/12875660) THE RIGHT SIDE; AND AN OCCLUSION OF THE GORE® EXCLUDER® ILIAC EXTENDER COMPONENT IMPLANTED WITHIN THE DISTAL LEFT EXTERNAL ILIAC ARTERY (PXL161407/12346676). A ULTRASOUND GUIDED RIGHT COMMON FEMORAL ACCESS FOR INITIATION OF CATHETER DIRECTED THOMBOLYTICS WAS ADMINISTERED. THE PATIENT TOLERATED THE PROCEDURE AND WAS RELEASED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2023 FOLLOW-UP CTA WAS PERFORMED AND REPORTED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 59MM. ADDITIONALLY, THE PATIENT WAS REPORTED TO HAVE AN INTRAABDOMINAL AND RETROPERITONEL HEMORRHAGE/AORTIC RUPTURE AND UNDERWENT PLACEMENT OF AN AORTOBIFEMORAL BYPASS GRAFT, A BILAT

  Patient problems: Rupture

  MAUDE report 18345728 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND ILIAC EXTENDER). ON NOVEMBER 17, 2023, THE FIELD SALES ASSOCIATE (FSA) WAS INFORMED BY THE PHYSICIAN THAT THERE IS A PATIENT WHO HAS A TYPE 1A ENDOLEAK AS THE TRUNK IPSILATERAL STENT GRAFT APPEARS TO BE ABOUT 22MM FROM THE RENAL ARTERIES. IN ADDITION, THE CT SCAN SHOWED THAT THE PATIENT HAS CONTRAST OUTSIDE THE LEFT LIMB (CONTRAST LEAKING OUT OF THE GRAFT), WHICH IS THE ILIAC EXTENDER AS THE ILIAC ARTERY HAS EXPANDED AROUND THE LIMB, HOWEVER IT DOES NOT APPEAR TO BE FILLING THE SAC. THE PHYSICIAN PLANS TO PUT AN AORTIC EXTENDER (CUFF) IN AND LAND UP TO THE RENALS BY EXTENDING PROXIMALLY FROM THE TRUNK IPSILATERAL STENT GRAFT. PATIENT IS GOING TO BE MONITORED. PHYSICIAN BELIEVES THE ENDOLEAK OCCURRED BECAUSE THE GRAFT IS 22MM DOWN FROM THE RENAL ARTERIES AND A REINTERVENTION WILL BE NEEDED BUT NO DATE FOR REINTERVENTION HAS BEEN DECIDED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18322730 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011 THE PATIENT UNDERWENT EVAR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AS REPORTED THE DISEASE CONTINUED TO PROGRESS AND AS IT PROGRESSED THE DISTAL SEAL WAS LOST. AS REPORTED THE DISTAL ENDOLEAK WAS OFF OF THE IPSILATERAL SIDE (ON THE PATIENT¿S LEFT) WHERE THE GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS WAS INITIALLY IMPLANTED. ON (B)(6) 2022 THE PATIENT UNDERWENT REINTERVENTION IN WHICH THE PHYSICIAN PUT AN AMPLATZER PLUG INTO THE LEFT HYPOGASTRIC ARTERY AND EXTENDED INTO THE EXTERNAL ILIAC ARTERY WITH A PLC121400 (SN: (B)(4)). THE PATIENT TOLERATED THE PROCEDURE AND IT WAS CONFIRMED THAT THERE WERE NO ENDOLEAKS AT THE CONCLUSION OF THE PROCEDURE. AS REPORTED THERE WERE NO ISSUES WITH THE IMPLANTED ENDOPROSTHESES AND THE EVENT WAS PURELY RELATED TO ONGOING DISEASE PROGRESSION.

  Patient problems: Aneurysm

  MAUDE report 13802927 ↗
• InjuryDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNSPECIFIED DATE IN 2002 THE PATIENT WAS IMPLANTED WITH A NON-GORE AORTIC TRUNK DEVICE (ANCURE) FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011 THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER (PXL161407). ON (B)(6) 2013 A REINTERVENTION OCCURRED IN WHICH THE EXISTING CONFIGURATION, INCLUDING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER, WAS RELINED WITH THE FOLLOWING GORE DEVICES: 3 GORE® EXCLUDER AORTIC EXTENDER ENDOPROSTHESIS (PXA230300), 1 GORE® EXCLUDER CONTRALATERAL LEG ENDOPROSTHESIS (PXC121000), AND 1 GORE® ILIAC EXTENDER ENDOPROSTHESIS (PXL161207). THE SPECIFIC REASON FOR THE REINTERVENTION IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 13048896 ↗
• InjuryFeb 9, 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 FOR A LEFT COMMON ILIAC ARTERY ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION FOR CONTINUED GROWTH AND DILATION OF THE ANEURYSM DUE TO DISEASE PROGRESSION. THE LEFT HYPOGASTRIC ARTERY WAS COIL EMBOLIZED AND THE PREVIOUSLY IMPLANTED ILIAC EXTENDER COMPONENT WAS EXTENDED WITH TWO ADDITIONAL ILIAC EXTENDER COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11302916 ↗
• InjuryAug 27, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REVEALED A DISTAL TYPE I ENDOLEAK IN THE LEFT LIMB. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE DEVICE TO THE LEFT EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED. REPORTEDLY, NO ENDOLEAK WAS OBSERVED IN THE PROXIMAL NECK AND THE RIGHT LIMB, HOWEVER, AN AORTIC EXTENDER ENDOPROSTHESIS AND A CONTRALATERAL LEG ENDOPROSTHESIS WERE DEPLOYED TO PREVENT A FUTURE TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. IT WAS SUGGESTED AS A POSSIBLE CAUSE OF DISTAL TYPE I ENDOLEAK WAS THAT THE LEFT LIMB DEVICE WOULD BE UNDERSIZED. IN ADDITION, IT WAS REPORTED THAT THE BLOOD VESSEL DIAMETER AROUND THE LEFT LIMB WAS ENLARGED FROM APPROX. 13 MM TO 16 MM.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10463559 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, THE PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK OF THE RIGHT LEG. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND AN ILIAC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN'S OPINION OF THE ROOT CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS NOT OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10212520 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE BEEN IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. ON (B)(6) 2019, A POSSIBLE PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS REPORTED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE LOCATION OF THE ENDOLEAK, BUT THE ANEURYSMAL SAC WAS GROWING. THE PHYSICIAN PLANNED A REINTERVENTION TO RELINE WITH AN AORTIC CUFFS AND TWO LIMBS. REINTERVENTION OCCURRED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580854 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. IT WAS REPORTED THAT DISTAL TO ONE OF THE IMPLANTED DEVICES THERE IS A TIGHT STENOTIC LESION. THERE WAS A REINTERVENTION ON (B)(6) 2019. THE STENOSIS WAS ON THE LEFT SIDE AND DISTAL TO THE PXL161407/06400307 DEVICE. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND EXTENDED PAST THE STENOSIS. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8497849 ↗
• InjuryFeb 25, 2019Adverse 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 AORTIC ANEURYSM OF 54MM MAXIMUM DIAMETER. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. IT WAS REPORTED THAT THE PROCEDURE INCLUDED IMPLANT OF A GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2016, COMPUTED TOMOGRAPHY SCAN (CT) REVEALED THAT THE MAXIMUM ANEURYSM DIAMETER WAS 57.3MM. FOLLOW UP CT SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM INCREASE IN SIZE FROM 46.8MM MEASURED ON (B)(6) 2016 TO 53.8MM MEASURED ON (B)(6) 2017. REPORTEDLY, ON (B)(6) 2017, A LEFT EXTERNAL ILIAC ARTERY PSEUDOANEURYSM WAS IDENTIFIED. IT WAS REPORTED THAT THE PSEUDOANEURYSM WAS UNRELATED TO THE DEVICE AND PROCEDURE, AND IT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REPORTEDLY, THE PSEUDOANEURYSM HAD NO COMMUNICATION WITH THE MAIN AORTIC ANEURYSM AND GORE® ENDOPROSTHESES WERE NOT IMPLANTED IN THE AREA OF PSEUDOANEURYSM. NO TREATMENT WAS REQUIRED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 8367460 ↗
• InjuryFeb 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND TWO ADDITIONAL GORE® EXCLUDER® ILIAC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO EXTEND COVERAGE DISTALLY ON THE LEFT SIDE, WITH INTENTIONAL COVERAGE OF THE HYPOGASTRIC ARTERY. COIL EMBOLIZATION OF THE LEFT HYPOGASTRIC ARTERY AND A FEMOROFEMORAL BYPASS WERE ALSO PERFORMED. THE PATENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 8311789 ↗
• InjurySep 11, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT281418/(B)(4), PXL161407/(B)(4), PLA280300/(B)(4), PXC141400/(B)(4), AND PXC141200/(B)(4)) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK WITH ANEURYSMAL ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2018, THE PATIENT UNDERWENT COIL-EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT THE TYPE II ENDOLEAK. HOWEVER, THE ENDOLEAK REPORTEDLY REMAINED AFTER THE PROCEDURE. ON (B)(6) 2015, A TYPE II ENDOLEAK ORIGINATING FROM THE IMA AND LUMBAR ARTERIES WAS CONFIRMED BY COMPUTED TOMOGRAPHIC ANGIOGRAPHY. ON THIS DATE, THE PATIENT UNDERWENT AN OPEN PROCEDURE WHEREBY THE STENT GRAFT COMPONENTS WERE EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND, THEREFORE, WERE NOT AVAILABLE FOR ANALYSIS BY GORE.

  Patient problems: No Code Available

  MAUDE report 7865440 ↗

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)