Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-31-111-80-12-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055715611534), received between Aug 17, 2016 and Jun 19, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT: TYPE 1A AND 1B ENDOLEAKS POST PROCEDURE / RE-INTERVENTION ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2017. THE FINAL ANGIOGRAPHY REVEALED A TYPE 1A ENDOLEAK. RE-BALLOONING WAS PERFORMED USING A RELIANT BALLOON CATHETER (MEDTRONIC (B)(4)). ONLY A TYPE 4 ENDOLEAK REMAINED. THE ORIGINAL PROCEDURE WAS FINISHED. FOLLOW-UP CT IMAGES WERE TAKEN ONE WEEK AFTER THE ORIGINAL PROCEDURE AND REVEALED A TYPE 1A ENDOLEAK. ON (B)(6) 2017, THE PHYSICIAN PERFORMED A RE-INTERVENTION TO RESOLVE THE TYPE 1A ENDOLEAK BY PLACING AN EXCLUDER CUFF (28.5MM, GORE) IT WAS ALSO CONFIRMED THAT A TYPE 1B ENDOLEAK WAS PRESENT AT THE RIGHT COMMON ILIAC ARTERY. TO RESOLVE THIS, THE PHYSICIAN PLACED ANOTHER EXCLUDER CUFF (23MM, GORE). THIS DID NOT RESOLVE THE TYPE 1B ENDOLEAK, THEREFORE ANOTHER EXCLUDER CUFF (23MM, GORE) WAS ALSO PLACED. BOTH THE TYPE 1A AND 1B ENDOLEAKS WERE RESOLVED. THE PROCEDURE WAS FINISHED WITHOUT FURTHER ISSUES. AT THE END OF (B)(6) 2017 (EXACT DATE UNKNOWN), IT WAS CONFIRMED THAT THE PATIENT PASSED AWAY FROM RESPIRATORY FAILURE, UNRELATED TO THE DEVICE AND POSSIBLY PROCEDURE RELATED.

  Patient problems: Aneurysm

  MAUDE report 6649512 ↗
• InjuryAug 17, 2016Patient-Device Incompatibility; Patient-Device Incompatibility

  EVAR WAS PERFORMED ON (B)(6) 2016. CEREBRAL INFARCTION AND PERIPHERAL THROMBOTIC OCCLUSION ON BOTH SIDES. RE-INTERVENTION PERFORMED TO TREAT THROMBOTIC OCCLUSION AND ENDOLEAK ALSO RESOLVED. THE PROCEDURE WAS PERFORMED BY PLACING A MAIN BODY FROM THE RIGHT APPROACH FOLLOWING THE IFU. FINAL ANGIOGRAPHY REVEALED A TYPE 1A ENDOLEAK AT THE PROXIMAL NECK. THE DECISION WAS MADE TO MONITOR THE ENDOLEAK. POST OPERATION, AFTER ADMISSION TO ICU, THE PATIENT EXPERIENCED A COLD SENSATION IN BOTH LOWER LEGS. THE PHYSICIAN CONFIRMED A SUSPECTED PERIPHERAL VASCULAR THROMBOTIC OCCLUSION WHICH WAS PRESENT. AT THIS POINT, IT WAS ALSO CONFIRMED THAT THERE WERE SYMPTOMS OF CEREBRAL INFARCTION. A RE-INTERVENTION WAS PERFORMED TO TREAT THE PERIPHERAL VASCULAR THROMBOTIC OCCLUSION BY PLACEMENT OF A ZILVER STENT (COOK) WHICH WAS SUCCESSFUL. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED BY PLACING A COMPETITORS EXCLUDER 32MM CUFF.

  Patient problems: Aneurysm; High Blood Pressure/ Hypertension; Infarction, Cerebral; Occlusion; Peripheral Vascular Disease; Thrombus

  MAUDE report 5882234 ↗