Masters Series™ 19CAVGJ-514 00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067044037), received between Jul 3, 2024 and Jul 3, 2024 — classified as 1 death.

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.

• DeathJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 19MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS IMPLANTED. IT WAS REPORTED THAT THE GRAFT MATERIAL WAS HARD IN CONSISTENCY AND THE SUTURE POINTS WERE NOT SEALED PROPERLY, WHICH LED TO BLEEDING EVEN AFTER HEMOSTASIS WAS ACHIEVED. ADDITIONAL SUTURES WERE MADE, HEMOSTATIC AGENT WAS USED, GLUE WAS USED, AND ACTIVATED CLOTTING TIME (ACT) LEVEL WAS MAINTAINED AT 120 SECONDS. BLOOD TRANSFUSION AND PLATELETS WERE GIVEN. THE PATIENT DIED OF CARDIOGENIC SHOCK 48 HOURS AFTER THE PROCEDURE ON (B)(6) 2024. THE ISSUE WITH THE DEVICE WAS REPORTED TO BE WITH THE GRAFT TISSUE AND NOT THE VALVE ITSELF. THE VALVE WAS FUNCTIONING APPROPRIATELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 19666303 ↗