Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-81-63-16-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715606813), received between Jun 22, 2016 and Jun 22, 2016 — classified as 1 injury.

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.

• InjuryJun 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURE WAS PERFORMED BY PLACING A MAIN BODY DEVICE FROM THE RIGHT APPROACH FOLLOWING THE IFU. BECAUSE THE RIGHT COMMON ILIAC ARTERY HAD AN ANEURYSM, THE PHYSICIAN PREOPERATIVELY PLANNED TO PLACE AN EXCLUDER DEVICE (GORE, DIA.: 23 MM) IN THE DISTAL PORTION OF THE IPSILATERAL SIDE. THE PHYSICIAN WENT ON TO DEPLOY A CONTRA-LATERAL LIMB HOWEVER DUE TO A TECHNICAL ERROR, THE OVERLAPPING MARGIN WAS INSUFFICIENT. THE PHYSICIAN ADDED AN EXTENDER (HDE-12-82) AS A BRIDGE TO ADDRESS THIS ISSUE. FOLLOWING REVIEW OF THE DISTAL LANDING ZONE, FURTHER EXTENSION WAS REQUIRED AND THE PHYSICIAN EXTENDED IT WITH A DISTAL EXTENDER DEVICE. ADDITIONALLY, HE ALSO PLACED A BARE STENT TO PREVENT STENOSIS WHILE PERFORMING A LANDING IN THE EXTERNAL ILIAC ARTERY. THE FINAL ANGIOGRAPHY REVEALED A TYPE IV ENDOLEAK AND AN OCCLUSION OF THE RIGHT LOWER RENAL ARTERY. AS A COUNTERMEASURE, THE PHYSICIAN ATTEMPTED TO APPROACH FROM THE BRACHIAL ARTERY, BUT CANNULATION IN THE RENAL ARTERY WAS UNSUCCESSFUL THEREFORE NOT PROGRESSED. THE PHYSICIAN PLACED AN ADDITIONAL BARE STENT IN ORDER TO OBTAIN A GOOD BLOOD FLOW TO THE LEFT RENAL ARTERY. THE PROCEDURE WAS FINISHED.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 5741606 ↗