GORE EXCLUDER AAA Endoprosthesis PLL161207Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132618798), received between Dec 19, 2018 and Apr 2, 2026 — classified as 1 death, 4 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO LIMB OCCLUSION, THE PATIENT PRESENTED WITH ISCHEMIA OF LOWER LIMB.

  Patient problems: Insufficient Information

  MAUDE report 24771934 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2021, A GORE® EXCLUDER® AAA ENDOPROSTHESES WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). DUE TO THE PATIENT¿S TORTUOUS ANATOMY, THE PHYSICIAN CHOSE TO EXPLANT THE PREVIOUSLY IMPLANTED GRAFTS AND PERFORM A SURGICAL CONVERSION. THE PATIENT TOLERATED THE REINTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm expansion

  MAUDE report 19543330 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 10 COMMON ILIAC ARTERY (CIA) PSEUDOANEURYSM AND WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON OR ABOUT (B)(6) 2022, THE PATIENT PRESENTED WITH FEVER SYMPTOMS AND THE PHYSICIAN DETERMINED A SUSPECTED INFECTION OF THE GORE® EXCLUDER® AAA ILIAC EXTENDER ENDOPROSTHESIS. ON (B)(6) 2022, THE PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT EXPLANT OF THE DEVICE AND INFECTION WAS CONFIRMED. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS PRE-EXISTING PRIOR TO IMPLANT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16326493 ↗
• InjuryNov 23, 2022Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS OBTAINED FROM VOLUNTARY USER FACILITY MDR REPORT #5112721: ON AN UNKNOWN DATE, GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO TREAT AN UNKNOWN ETIOLOGY. ON OR ABOUT (B)(6) 2022, ACUTE OCCLUSION OF THE RIGHT LIMB OF THE EXCLUDER ENDOGRAFT, GORE EXCLUDER MAIN BODY (28.5X14.5X12), GORE LEFT LIMB (12X10), AND GORE RIGHT LIMB (12X7) WAS REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15850100 ↗
• DeathJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND SEVERAL GORE® VIABAHN® ENDOPROSTHESES TO TREAT AORTOILIAC OCCLUSIVE DISEASE ALSO KNOWN AS CERAB. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED IN THE INFRARENAL AORTA TOWARDS THE AORTIC BIFURCATIONS AND THEN THE PHYSICIAN IMPLANTED GORE® VIABAHN® ENDOPROSTHESES BILATERALLY IN BOTH COMMON ILIAC ARTERIES TO GIVE INFLOW DISTALLY TO KEEP ARTERIES OPEN FOR DISTAL BI-PASSES IN THE LEGS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2019, DUE TO BOWEL ISCHEMIA. THE PHYSICIAN STATED THAT HE FELT THE CAUSE OF THE BOWEL ISCHEMIA WAS DUE TO AN EMBOLIC EVENT OR THE COVERING OF THE INTERNAL MESENTERIC ARTERY, WHICH WAS PLANNED. THE CAUSE OF THE BOWEL ISCHEMIA IS UNKNOWN, THERE WAS NO POST MORTEM AUTOPSY PERFORMED.

  Patient problems: Occlusion

  MAUDE report 9545355 ↗
• MalfunctionAug 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. DUE TO A PARTLY ANEURYSMATIC COMMON ILIAC ARTERY ON THE LEFT PATIENT SIDE, IT WAS DECIDED TO PERFORM AN EXTENSION REACHING TO THE LEVEL OF THE ILIAC ARTERY BIFURCATION. A GORE® EXCLUDER® ILIAC EXTENDER COMPONENT PLL161207 WAS ADVANCED TO THE INTENDED LOCATION AND REPORTEDLY DEPLOYED SAFELY OUTSIDE OF THE GORE DRYSEAL FLEX INTRODUCER SHEATH DSF(12/33). FOLLOWING DEPLOYMENT, AND FOR THE FIRST FEW CENTIMETERS, THERE WERE NO PROBLEMS RETRACTING THE DEVICE CATHETER BUT THEN SEVERE RESISTANCE WAS MET. TO OVERCOME THE RESISTANCE, THE ATTEMPT WAS MADE TO RETRACT THE DEVICE CATHETER WITH FORCE BACK INTO THE SHEATH, REALIZING THAT THE PLL ENDOPROSTHESIS, BELIEVED TO HAVE BEEN RELEASED FROM THE CATHETER DURING DEPLOYMENT, WAS ALSO PULLED BACK AGAIN INTO THE SHEATH. THIS WAS CONFIRMED BY FLUOROSCOPY IMAGING. TO REMEDY THE SITUATION, IT WAS DECIDED TO REMOVE THE SHEATH AND RETRIEVE FROM IT THE DEVICE CATHETER AND THE DEPLOYED PLL DEVICE. REPORTEDLY, A NEW SHEATH WAS SUBSEQUENTLY ADVANCED INTO THE PATIENT AND A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932814 ↗
• MalfunctionDec 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AS WELL AS BILATERAL ILIAC ARTERY ANEURYSMS AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT261418 WAS EXTENDED WITH A GORE® EXCLUDER® ILIAC EXTENDER COMPONENT PLL161207 TO INTENTIONALLY COVER THE PATIENT'S LEFT AND PREVIOUSLY COILED, HYPOGASTRIC ARTERY. DURING THE ATTEMPT TO DEPLOY THE PLL161207 COMPONENT, THE DEPLOYMENT LINE WAS PERCEIVED TO HAVE DETACHED FROM THE DEPLOYMENT KNOB AND WAS CONSIDERED BROKEN. THE UN-DEPLOYED DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS CONCLUDED AS PLANNED WITH A NEW ENDOPROSTHESIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180346 ↗

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