GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT261212Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132651023), received between Jul 22, 2021 and Nov 27, 2022 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2022Positioning Problem; Positioning Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN ZONE 9-INFRARENAL USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PHYSICIAN POSITIONED THE DEVICE PROXIMAL OF THE RENAL ARTERIES AND WANTED TO CANNULATE THE GATE. DEVICE WAS DEPLOYED PER FIRST STEP OF DEPLOYMENT, AND THE GATE WAS CANNULATED. THE PHYSICIAN ATTEMPTED TO CONSTRAIN AND REPOSITION THE DEVICE AND PULL IT DISTAL OF RENAL ARTERIES (PLANNED FINAL POSITION), THE DEVICE WOULD NOT SLIDE DOWN. ¿AT ONE POINT IT WAS NOTICED UNDER IMAGING THAT THE PROXIMAL OLIVE WAS INSIDE THE DEVICE AND WAS NOT ACTUALLY MOVING THE DEVICE.¿ THE DEVICE WAS PUSHED PROXIMAL, AND THE OLIVE WAS OUTSIDE OF THE GRAFT. UNDER IMAGING THERE WAS A VISIBLE ¿UNKNOWN WIRE¿ THAT WAS NO LONGER ATTACHED TO THE TIP OF THE DELIVERY SYSTEM. THE PHYSICIAN CHOSE TO PERFORM AN OPEN CONVERSION AND EXPLANTED THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15867117 ↗
• MalfunctionMay 11, 2022Use of Device Problem; Use of Device Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE DEVICE WAS PREPARED PER IFU, HOWEVER, IT WAS DIFFICULT TO REMOVE THE PACKAGING MANDREL. WHILE ATTEMPTING TO ADVANCE THE DELIVERY CATHETER THROUGH THE SHEATH VALVE, A METAL PIECE (EXTENDING FROM EPTFE MATERIAL) PUNCTURED THE SHEATH VALVE (SHEATH LOT/SERIAL NUMBER IS UNKNOWN, HOSPITAL STOCK). THE UNKNOWN METAL (FSA STATED "IT IS UNKNOWN WHAT/WHERE THE WIRE WAS COMING FROM, LOCK PIN OR APEX OR ANCHOR"). 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 14353609 ↗
• DeathNov 11, 2021Material Invagination; Material Invagination

  ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PHYSICIAN STATED THE CAUSE OF DEATH WAS MULTISYSTEM ORGAN FAILURE. THE PHYSICIAN STATED THE MULTISYSTEM ORGAN FAILURE COULD HAVE BEEN CAUSED BY THE EMERGENT CONVERSION DUE TO THE RUPTURE OF THE AORTA WHEN BALLOONING THE TWO LIMBS DOWN CLOSE TO THE AORTIC BIFURCATION. SHE ENDED UP HAVING ISSUES DUE TO PROLONGED ANESTHESIA OF ALMOST 8 1/2 TO 9 HOURS. AS WELL THE PATIENT WAS NOT AN IDEAL SURGICAL CANDIDATE IN THE FIRST PLACE AND THAT WAS THE REASON FOR ATTEMPTING THE ENDOVASCULAR REPAIR.

  Patient problems: Aneurysm

  MAUDE report 12800769 ↗
• MalfunctionJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6)2021, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY AT AN UNKNOWN ANATOMICAL LOCATION AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT). THE PHYSICIAN DELIVERED THE CXT DEVICE THROUGH AN 18F DRY SEAL SHEATH OVER A MEIER WIRE. THE CXT DEVICE WAS FULLY DEPLOYED. UPON REMOVAL OF THE DELIVERY SYSTEM, THE OLIVE TIP BROKE OFF, THE PHYSICIAN SUCCESSFULLY SNARED THE OLIVE TIP AND IT WAS REMOVED WITHOUT FURTHER ISSUE. THE PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214958 ↗