MalfunctionMAL

HEMASHIELD PLATINUM GRAFT

Received Apr 21, 2026 · Event occurred Nov 21, 2025

Report MW5187051 · MDR key 24941588

Device

Generic name

Graft, Vascular, Synthetic/biologic Composite

Manufacturer

Intervascular Sas

Patient

73 YR · Male

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PERFORMED ASCENDING AORTA REPLACEMENT AND CABG REQUIRING AXILLARY CANNULATION. HEMASHIELD PLATINUM GRAFT USED FOR AXILLARY CANNULATION LEAKED THE WHOLE PROCEDURE. WHILE IT IS NORMAL FOR THERE TO BE SOME WEEPING THROUGH THE GRAFT, THIS GRAFT WAS LEAKING A SUFFICIENT AMOUNT OF BLOOD TO POOL IN THE DRAPES SEVERAL TIMES. GRAFT SAVED AND PASSED TO RESOURCE NURSE AT THE END OF THE CASE.