Zenith Flex G48479Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002484792), received between May 6, 2016 and May 6, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 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.

• DeathMay 6, 2016Material Rupture; Material Rupture

  ON (B)(6) 2013, A MALE PATIENT WHO WAS (B)(6) YEARS OLD AT TIME OF REPORTED EVENT HAD UNDERGONE AAA REPAIR WITH THE RIGHT APPROACH. THE PATIENT WAS SUITABLE FOR THE EVAR AND THE PROCEDURE WAS CONDUCTED AS LABELED. A 12 MM X 107 MM RIGHT ILIAC LEG GRAFT WAS PLACED IN THE EIA WITH THE RIGHT IIA COIL-EMBOLIZED DUE TO CIA ANEURYSM. THE 24 MM X 90 MM LEFT ILIAC LEG GRAFT WAS PLACED IN THE CIA. ON (B)(6) 2013: CT ANGIOGRAPHY SHOWED NO PROBLEM. ON (B)(6) 2014: CT ANGIOGRAPHY SHOWED NO PROBLEM. ON (B)(6) 2014: CT ANGIOGRAPHY SHOWED SLIGHT ENLARGEMENT OF THE ANEURYSM DIAMETER, BUT THERE WAS NO ENDOLEAK OBSERVED. ON (B)(6) 2015: CT ANGIOGRAPHY SHOWED ENLARGEMENT OF THE ANEURYSM DIAMETER, BUT THERE WAS NO ENDOLEAK OBSERVED. ON (B)(6) 2015: CT ANGIOGRAPHY SHOWED FURTHER ENLARGEMENT OF THE ANEURYSM DIAMETER, BUT THERE WAS NO ENDOLEAK OBSERVED. ON (B)(6) 2016: PLAIN CT CONDUCTED TO MINIMIZE THE ADVERSE EFFECTS ON THE PATIENT SHOWED NO ENDOLEAK AND NO CHANGE IN THE DIAMETER OF THE ANEURYSM SINCE (B)(6) 2015. ON AN UNKNOWN DATE, THE PATIENT WAS TRANSPORTED EMERGENTLY IN CARDIAC OR RESPIRATORY ARREST. THOUGH CT ANGIOGRAPHY WAS PERFORMED WITH CARDIAC MASSAGE GIVEN, NO PARTICULAR TREATMENT WAS CONDUC

  Patient problems: Death

  MAUDE report 5638061 ↗