Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-111-63-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715611473), received between Aug 5, 2016 and Aug 5, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathAug 5, 2016Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT DIED FROM COMMON ILIAC ARTERY RUPTURE. EVAR WAS PERFORMED ON (B)(6) 2016. THE PHYSICIAN ATTEMPTED TO INTRODUCE THE PLUG-IN LEG, HOWEVER CAME UP AGAINST RESISTANCE, THEREFORE THE DECISION WAS MADE TO REMOVE THE DEVICE. THE PHYSICIAN BALLOONED THE VESSEL TO AID INSERTION OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS RE-INTRODUCED HOWEVER, THE PATIENT BEGAN TO HEMORRHAGE. THE LEG WAS A PLANNED EXTENSION IN ORDER TO EXCLUDE THE ANEURYSM HOWEVER WHEN IMPLANTED IT WAS HOPED THAT IT WOULD ALSO CREATE A SEAL JUST ABOVE THE HEMORRHAGE FROM THE UPPER COMMON ILIAC ARTERY. FINALLY, THE PHYSICIAN PLACED A DISTAL EXTENDER TO COMPLETE THE PROCEDURE. THE PATIENT'S HEMORRHAGING CONTINUED AND THE PHYSICIAN WAS UNABLE TO STOP THE HEMORRHAGING INTO THE ABDOMEN. THE PATIENT PASSED AWAY DURING THE PROCEDURE.

  Patient problems: Aneurysm; Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5849835 ↗