Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-81-80-14-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715606868), received between Mar 24, 2016 and Nov 23, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Positioning Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2016Positioning Problem; Positioning Problem

  ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. THE PHYSICIAN PLACED THE MAIN BODY STENT GRAFT FROM THE LEFT FEMORAL ARTERY APPROACH AND A CONTRALATERAL LEG FROM THE RIGHT APPROACH. PRIOR TO COMPLETION OF THE PROCEDURE, THE PHYSICIAN HAD CONFIRMED THAT A PRESSURE GAP WAS PRESENT BETWEEN THE RIGHT AND LEFT LEGS. BECAUSE THE LEFT LEG PRESSURE WAS LOWER, THE PHYSICIAN RE-INFLATED A BALLOON CATHETER IN THE IPSILATERAL LIMB IN ORDER TO ADJUST IT. EVEN THOUGH A SLIGHT PRESSURE GAP WAS STILL PRESENT AT THAT TIME, THE PHYSICIAN DECIDED THAT IT WAS ACCEPTABLE AND FINISHED THE PROCEDURE. THE FINAL ANGIOGRAPHY REVEALED A PATENCY OF THE STENT GRAFT. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2016, HOWEVER THE NEXT DAY THE PATIENT REPORTED A PAIN IN THE LEFT LEG. CT IMAGING PERFORMED ON (B)(6) 2016 REVEALED THROMBUS IN THE IPSILATERAL LIMB. BLOOD FLOW INTO THE DISTAL PORTION WAS SECURED FROM ANOTHER VESSEL. THE CT IMAGE REVEALED AN OCCLUSION OF THE PROXIMAL PORTION OF THE IPSILATERAL LIMB. THE PHYSICIAN CARRIED OUT A RE-INTERVENTION WHERE A SURGICAL THROMBECTOMY WAS PERFORMED WITH A FOGARTY BALLOON CATHETER, PLACING A BALLOON EXPANDABLE STENT (10MM X 3CM, ASSURANT COBALT, MEDTRONIC) AT THE

  Patient problems: Aneurysm; Occlusion; Thrombus

  MAUDE report 6124514 ↗
• InjuryMar 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVAR WAS PERFORMED (B)(6) 2016. LEFT RENAL ARTERY OCCLUSION. TYPE 1A ENDOLEAK. THE PROCEDURE WAS PERFORMED BY PLACING A MAIN BODY FROM THE LEFT APPROACH FOLLOWING THE IFU. THE PHYSICIAN ATTEMPTED TO LOWER AND DEPLOY THE MAIN BODY BY ADJUSTING FROM A PORTION 1 CM UPPER FROM THE LEFT RENAL ARTERY. AT A STAGE WHERE HE DEPLOYED IT TO THE CONTRA-LATERAL SOCKET, HE RELEASED A SUPPORT TUBE, PERFORMED A CANNULATION ON THE CONTRA-LATERAL LEG AND INFLATED A BALLOON CATHETER IN THE PROXIMAL PART FROM THE CONTRA-LATERAL SIDE. AFTER DEPLOYING AN IPSI-LATERAL LIMB, HE PLACED A CONTRA-LATERAL LIMB. AFTER INFLATING A BALLOON CATHETER THROUGHOUT THE WHOLE DEVICE, A FINAL ANGIOGRAPHY REVEALED NO IMAGE OF THE LEFT RENAL ARTERY AND A TYPE 1A ENDOLEAK. REGARDING THE EVENT 1, BY TAKING AN ACCESS FROM THE LEFT BRACHIAL ARTERY, HE ATTEMPTED TO ADVANCE A GUIDE WIRE FROM THE UPPER SIDE TOWARD THE LEFT RENAL ARTERY, BUT HE HAD A DIFFICULTY IN CANNULATION. THEN, HE CONCLUDED IT WAS IMPOSSIBLE TO PERFORM THE CANNULATION. REGARDING THE EVENT 2, BY ADDITIONALLY PLACING A PROXIMAL EXTENDER, THE TYPE 1A ENDOLEAK WAS RESOLVED. THE PROCEDURE WAS FINISHED WITH THE LEFT RENAL ARTERY OCCLUSION REMAINING. UPDATE RECEIVE

  Patient problems: Aneurysm; Ischemia; Occlusion

  MAUDE report 5522538 ↗