Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-81-80-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715606851), received between Mar 23, 2016 and May 5, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryMay 5, 2016Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  EVAR WAS PERFORMED ON (B)(6) 2016. DATE EVENT OCCURRED HAS BEEN SUPPLIED AS THE 4TH WEEK OF (B)(6) 2016 (NO SPECIFIC DATE HAS BEEN GIVEN). LIMB OCCLUSION (OCCURRED POST PROCEDURE) / RE-INTERVENTION THE PHYSICIAN PERFORMED THE PROCEDURE FOLLOWING THE IFU AND FINISHED IT WITHOUT ISSUES. SG-HBB WAS IMPLANTED IN THE ABDOMINAL AORTA BY THE RIGHT COMMON ILIAC ARTERY APPROACHING. SG-HBL-90-14 WAS PLACED IN THE CONTRA-LATERAL LEG. SG-HBL-90-12 WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY TOWARD THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THE PROCEDURE, THE PHYSICIAN TALKED WITH THE PATIENT OVER THE TELEPHONE AND KNEW THAT HE HAD CLAUDICATION. THE CT REVEALED THAT SOME THROMBOTIC OCCLUSION EXISTED FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. RE-INTERVENTION: IN THE WEEK OF (B)(6) 2016, THE PATIENT WILL VISIT THE HOSPITAL AND THE PHYSICIAN IS PLANNING TO PERFORM FEM-FEM BYPASS FOR HIM. LOMBARD MEDICAL REPRESENTATIVE HAS ADVISED THAT A 12MM DIAMETER STENT GRAFT WAS USED IN AN EXTERNAL ILIAC ARTERY WITH DIAMETER OF 8MM.

  Patient problems: Aneurysm; Claudication; Occlusion; Thrombus

  MAUDE report 5633695 ↗
• InjuryMar 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE-INTERVENTION PERFORMED ON (B)(6) 2016 TO TREAT PERSISTANT TYPE 1A ENDOLEAK. ORIGINAL EVAR PERFORMED ON (B)(6) 2015. A) LEFT IIA OCCLUSION, LEFT EIA DISSECTION; B) MINOR TYPE 1A ENDOLEAK. ORIGINAL EVAR INFORMATION: THE MAIN BODY WAS PLACED APPROACHING FROM THE LEFT FEMORAL ARTERY FOR THE ABDOMINAL EVAR FOLLOWING THE IFU. AFTER DEPLOYING THE CONTRA-LATERAL SOCKET, THE PHYSICIAN CANNULATED IT. AFTER THE CANNULATION, HE INITIATED DEPLOYMENT OF THE IPSI-LATERAL LIMB. REGARDING THE ISSUE A), HE ATTEMPTED TO CROSS OVER A CATHETER FROM THE CONTRA-LATERAL SIDE TOWARD THE IPSI-LATERAL SIDE FOR ANGIOGRAPHY. HOWEVER, THE ANGIOGRAPHY REVEALED NOTHING. THEREFORE, TARGETING AROUND THE RIGHT INTERNAL ILIAC ARTERY, HE DEPLOYED THE DEVICE A BIT LOWER, JUDGING THAT THERE WOULD BE NO PROBLEM WHILE OBSERVING THE 3D IMAGES TAKEN BEFORE PROCEDURE. WHEN TRYING TO DOCK THE PROXIMAL TIP OF THE DELIVERY SYSTEM, THE DEVICE WAS ENTRAPPED AT THE DISTAL PART OF THE IPSI-LATERAL SIDE AND THE DISTAL PART MIGRATED. THE FINAL ANGIOGRAPHY REVEALED THAT THE LEFT INTERNAL ILIAC ARTERY WAS OCCLUDED. REGARDING THE ISSUE B), THE FINAL ANGIOGRAPHY REVEALED A MINOR TYPE 1A ENDOLEAK. A) ALTHOUGH THE PHYSICIAN ATTEMPTED TO

  Patient problems: Aneurysm; Occlusion; Vascular Dissection

  MAUDE report 5519193 ↗