Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-96-80-14-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715612081), received between Jun 1, 2016 and Jun 1, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• DeathJun 1, 2016Patient-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  ORIGINAL EVAR WAS PERFORMED (B)(6) 2016. REPORTED TO LOMBARD MEDICAL ON 27 APR 2016 (NO REPORT OF DEATH). FOLLOWING THE IFU, A MAIN BODY (HBB-31-96-80) WAS INSERTED FROM THE LEFT APPROACH AND A CONTRA-LATERAL LIMB (HBL-90-14) WAS PLACED. TYPE IA ENDOLEAK WAS CONFIRMED. ALTHOUGH IT WAS ATTEMPTED TO ADD A DISTAL EXTENDER (HDE-14-51) IN THE IPSI-LATERAL LIMB, IT WAS IMPOSSIBLE TO PUSH UP THE DEVICE DUE TO THE EXCESSIVELY TORTUOUS COMMON ILIAC ARTERY. IN ORDER TO ADDRESS THE SITUATION 2), THE PHYSICIAN ATTEMPTED TO ADD A PROXIMAL EXTENDER FROM THE CONTRA-LATERAL SIDE OVER THE EGOIST GUIDE WIRE ((B)(4)) BY INFLATING A BALLOON CATHETER AROUND THE PROXIMAL NECK. HOWEVER, THE DEVICE WOULD NOT ADVANCE AND IT WAS SWITCHED TO ADVANCE IT FROM THE IPSI-LATERAL SIDE. ALTHOUGH THOSE ATTEMPTS WERE MADE, THE DEVICE WOULD NOT ADVANCE IN THE END. FINALLY, THE PHYSICIAN PLACED A CUFF (GORE, 32 MM) INSTEAD. AS A RESULT, THE TYPE IA ENDOLEAK WAS RESOLVED. THE PHYSICIAN FINISHED THE PROCEDURE, EVEN THOUGH THE FINAL ANGIOGRAPHY REVEALED A TYPE IV ENDOLEAK. IN ORDER TO WATCH IT, THE PATIENT WILL BE FOLLOWED-UP FROM NOW ON. PATIENT PASSED AWAY ON (B)(6) 2016. THIS WAS REPORTED TO LOMBARD MEDICAL ON 10 MAY 2

  Patient problems: Aneurysm; Death

  MAUDE report 5690605 ↗