Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-126-63-20-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715606653), received between Oct 29, 2015 and Oct 29, 2015 — 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.

• DeathOct 29, 2015No Apparent Adverse Event

  THE ORIGINAL PROCEDURE WAS PERFORMED ON THE (B)(6) 2015. THE INFORMATION RECEIVED ON THE SAME DAY DETAILS THE FOLLOWING: THE CASE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT DIED DURING THE PROCEDURE. THIS WAS NOT GRAFT RELATED.A SMALL INDUCED DISSECTION IN THE CONTRALATERAL EXPLORATORY CAUSED A CARDIAC EVENT AND PRESSURE DROP. DESPITE 70 MINUTES OF REANIMATION AND MOMENTARY PRESSURE INCREASE AND EMERGENCY MEASURES, THE PATIENT COULD NOT BE SAVED. FURTHER INFORMATION RECEIVED ON THE (B)(4) 2015 DETAILS THE FOLLOWING: THE MAIN BODY WAS IMPLANTED WITHOUT ISSUES. IT WAS NOT POSSIBLE TO CANNULATE THE CONTRA LATERAL SIDE. THE LEFT COMMON ILIAC ARTERY WAS VERY TORTUOUS AND IT WAS NOT POSSIBLE TO STRAIGHTEN WITH A STIFF WIRE. A 8F FLEXOR SHEET AND A WIRE WERE USED TO CROSS AN ANGULATED SECTION. THIS PARTICULAR STEP MAY HAVE CAUSED THE DISSECTION. A CONVERTER WAS IMPLANTED TO PREVENT THE LOSS OF BLOOD AND TO STOP THE BLEEDING.IMPLANTS USED IN THIS CASE:MODEL NUMBER LOT NUMBER EXPIRY DATE MANUFACTURE DATE UDI1) SG-HBB-24-126-63-20 1) CP58496-1 1) 06 JAN 2017 1) 06 JAN 2015 (B)(4)

  Patient problems: Aneurysm; Death; Vascular Dissection

  MAUDE report 5186958 ↗