Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-111-80-16-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715606516), received between Sep 21, 2016 and Sep 21, 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.

• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT - PARTIAL OCCLUSION OF RENAL ARTERY. THE PHYSICIAN PERFORMED AN EVAR PROCEDURE TO TREAT AN AAA FOLLOWING THE IFU. THE MAIN BODY WAS INSERTED BY THE RIGHT APPROACH. DURING DEPLOYMENT, THE PROXIMAL NECK OF THE MAIN BODY APPEARED TO TAKE AN ACCORDION SHAPE. THEREAFTER, THE PHYSICIAN PLACED THE MAIN BODY RIGHT BELOW THE LEFT LOWER RENAL ARTERY BY ADJUSTING THE FISHMOUTH TROUGHS. THE FINAL ANGIOGRAPHY REVEALED THAT THE LEFT LOWER RENAL ARTERY WAS COVERED BY HALF AND A TYPE 1A ENDOLEAK WAS PRESENT. THE INTERNAL ILIAC ARTERY HAD ALSO BEEN OCCLUDED. WHILE ATTEMPTING TO CANNULATE THE LEFT RENAL ARTERY, LUNDERQUIST GUIDE WIRE (COOK JAPAN, 260 CM) ONLY PASSED THROUGH IT, BUT THE CX ANGIOGRAPHY CATHETER (GADELIUS, 4 FR) WOULD NOT ADVANCE DUE TO AN ENTRAPMENT BY THE PROXIMAL FISHMOUTH TROUGH OF THE MAIN BODY. THE PHYSICIAN GAVE UP THE PLACEMENT OF THE STENT AT THE RENAL ARTERY. FROM A REVIEW OF THE PATIENT'S ANATOMY, THE PROXIMAL NECK WAS HIGHLY ANGULATED (95 DEGREES) THEREFORE, THIS CASE WAS PERFORMED OUTSIDE OF THE DEVICE INDICATIONS FOR USE.

  Patient problems: Aneurysm; Occlusion

  MAUDE report 5965959 ↗