Aorfix AAA Stent Graft Body with Aorflex Delivery System SG-HBB-24-96-80-16-A12-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055715607056), received between Apr 13, 2017 and Apr 13, 2017 — classified as 1 injury.

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.

• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT: ANEURYSM RUPTURE (RE-INTERVENTION AND PARTIAL EXPLANTATION) IT IS UNDERSTOOD FROM THE REPORT DATED 21.3.2017 (21 MAR 2017), THAT AFTER IMPLANTATION ON (B)(6) 2015, A SECONDARY INTERVENTION WAS PERFORMED USING APTUS ENDOANCHORS TO TREAT A PERSISTENT TYPE 1A ENDOLEAK ON (B)(6) 2016. THIS RE-INTERVENTION WAS NOT COMMUNICATED. IT IS ALSO UNDERSTOOD THAT THE TYPE 1A ENDOLEAK PERSISTED EVEN AFTER PLACEMENT OF THE APTUS ENDOANCHORS. THE PATIENT PRESENTED A RUPTURED ANEURYSM ON (B)(6) 2016 AND THE PROXIMAL PART OF THE ENDOGRAFT WAS REMOVED AND REPLACED BY A POLYESTER SURGICAL GRAFT WITH SUTURED ANASTOMOSES. IT IS UNDERSTOOD THAT AN EXPLICIT STATEMENT HAS BEEN MADE THAT AT THE TIME OF EXPLANTATION, THE PROSTHESIS WAS COMPLETELY SEALED AND HAD NOT LED DIRECTLY TO THE RUPTURE. IMAGES OF THE CASE HAVE NOT BEEN RECEIVED FOR REVIEW BUT IT SEEMS PROBABLE THAT THE CAUSE OF THE RUPTURE IS THE PERSISTENT TYPE 1A ENDOLEAK. IT IS ALSO UNDERSTOOD THAT THE SURGICAL TEAM NOTICED THAT THE GRAFT FABRIC OF THE ENDOGRAFT DID NOT LIE TIGHTLY AGAINST ALL OF THE WIRES RINGS WHICH REINFORCE IT AND THAT SOME OF THE WIRES PROJECT AWAY FROM THE GRAFT IN SMALL LOOPS. THIS APPEARS TO BE A COINCIDENTAL OBSERVAT

  Patient problems: Aneurysm

  MAUDE report 6489719 ↗