Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-63-16-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715606998), received between Nov 19, 2015 and Nov 19, 2015 — classified as 1 death.

The most frequently reported specific device problem is “Hole In Material” (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.

• DeathNov 19, 2015Hole In Material

  EVENT 1: KINKED LEG DEVICE DURING INSERTION. EVENT 2: RUPTURED ANEURYSM / DEATH (RE-INTERVENTION). EVAR WAS PERFORMED ON (B)(6) 2015. THE CASE WAS A CHALLENGING, HIGH-ANGLE EVAR. BILATERAL CUTDOWNS WERE PERFORMED AND MAIN BODY AORFIX WAS INSERTED INTO THE LEFT ILIAC AND DEPLOYED AT THE RENAL ARTERIES. AFTER CANNULATING THE EVAR GRAFT FROM THE RIGHT SIDE, A COUPLE ATTEMPTS WERE MADE TO DELIVER AN AORFIX CONTRALATERAL LIMB. THE CONTRALATERAL LIMB WOULD NOT PASS AND WAS REMOVED FROM THE BODY. UPON REMOVAL, IT WAS NOTICED THAT THE AORFIX CONTRA LIMB HAD KINKED TRYING TO DELIVER IT. A GORE LIMB WAS THEN USED TO GRAFT THE RIGHT COMMON ILIAC FROM THE AORFIX FLOW DIVIDER DOWN TO THE ILIAC BIFURCATION AND A COOK LIMB EXTENSION WAS USED TO EXTEND FURTHER INTO THE LEFT COMMON ILIAC. EVERYTHING WAS THEN BALLOONED AND A FINAL ANGIO RUN WAS PERFORMED. NO ENDOLEAKS WERE REPORTED AT THAT TIME. PHYSICIAN CALLED AT 12:58AM ((B)(6) 2015) STATING THAT THE PATIENT'S ANEURYSM HAD RUPTURED. PATIENT HAD A CT CONFIRMING THE AORTIC RUPTURE AND WAS CURRENTLY IN THE HYBRID SUITE BEING TREATED. PHYSICIAN THEN SPOKE WITH (B)(6) TO DISCUSS NEXT TREATMENT STEPS. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. UPDATE REC

  Patient problems: Aneurysm; Death; Rupture

  MAUDE report 5236416 ↗