MITROFLOW VALSALVA CONDUIT MVC28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057014931), received between Mar 22, 2017 and Mar 22, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• InjuryMar 22, 2017Fluid/Blood Leak; Fluid/Blood Leak

  BASED ON THE INFORMATION PROVIDED, ON (B)(6) 2017, A PATIENT UNDERWENT A BENTALL OPERATION AND TOTAL AORTIC ARCH REPLACEMENT FOR ACUTE TYPE A DISSECTION. A MITROFLOW CONDUIT AND CROWN PRT WERE IMPLANTED DURING THIS OPERATION. AFTER DECLAMPING, SLIGHT BLOOD LEAKAGE BETWEEN THE CUFF AND GRAFT OF CONDUIT WAS CONFIRMED. IT WAS POSSIBLY FROM A SUTURING SECTION OF THE CUFF AND GRAFT, BUT COULD ALSO BE FROM A SUTURING SECTION OF GRAFT COMPONENTS. THE PHYSICIAN PLACED SUTURES FROM THE CUFF TO GRAFT TWO TO THREE TIMES, AND THE BLOOD LEAKAGE STOPPED. NO APPARENT ADVERSE EVENT TO THE PATIENT WAS OBSERVED. ACCORDING TO THE PHYSICIAN, THE GRAFT WAS NOT DAMAGED WITH ANY TOOLS BEFORE LEAKAGE WAS OBSERVED. SURGEON STATES THAT SINCE THE BLOOD WAS POSSIBLY LEAKED BETWEEN THE CUFF AND GRAFT OF CONDUIT, DEVICE FAILURE CAN BE CONSIDERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6426353 ↗