It was reported to intervascular from the health facility that during his cardiac surgery intervention (bentall), the surgeon noticed that blood was beading all along the tube and that hemostasis was therefore impossible, which led to the use of biological glue and tachosil.The prosthesis has been placed in the patient.Additional information was received from the health facility for a better understanding of the event: the bleeding was noted during aortic declamping.The bleeding was local throughout the graft.The procedure was prolonged by one hour.Length of hospital stay prolonged.Consequence for the patient mild-moderate injury.Medical follow-up: additional medical intervention required: coagulation products.Additional surgical intervention required: tachosil on the vascular prosthesis.The patient required blood products: packed rbcs.Complaint # (b)(4).
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((b)(4)) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint is regarding a cardioroot graft used on (b)(6) 2023.While performing a bentall procedure on an 81-year-old female patient with a history of hypertension, the surgeon, a customary cardioroot user, observed bleeding throughout the prosthesis after removing the vascular clamp.Due to the nature of the bleeding and the inability to achieve hemostasis, the surgeon used tachosil, a fibrin sealant patch, and biological glue to stop the bleeding.The surgeon selected to leave the graft in place and not replace it.The patch placement and the glue application prolonged the case by approximately one hour; the patient required a transfusion of packed red blood cells and coagulation products.The complication and the treatment required to obtain hemostasis prolonged the hospital stay.The medical affairs team was unsuccessful in our attempts to contact the surgeon.Due to the limited information that we have received, we cannot comprehensively assess the event." ((b)(4)) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In (b)(6) 2023, the bleeding rate on intergard / hemagard products was within the maximum anticipated by the product risk assessment.((b)(4)) based on the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
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