Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-81-80-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715611893), received between Jul 13, 2016 and Jul 13, 2016 — classified as 1 death.

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.

• DeathJul 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. AFTER PLACING THE MAIN BODY AND A CONTRA-LATERAL LIMB, THE PHYSICIAN INFLATED A BALLOON CATHETER. THE FINAL ANGIOGRAPHY REVEALED A TYPE 1A ENDOLEAK IN THE PROXIMAL PORTION. THE PHYSICIAN RE-BALLOONED, HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN PLACED A PROXIMAL EXTENDER (SG-HPE), HOWEVER THE ENDOLEAK STILL REMAINED. FINALLY, AN ENDURANT CUFF (MEDTRONIC) WAS IMPLANTED. ON FINAL RUN, THE TYPE 1A AND TYPE 4 REMAINED. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS TO BE FOLLOWED-UP. UPDATE RECEIVED ON 22 JUN 2016, THE ANEURYSM HAD RUPTURED AND THE PATIENT DIED.

  Patient problems: Aneurysm; Death

  MAUDE report 5789084 ↗