Corrected data: on block h6, based on the investigation conclusion, the initial problem code "3190" was updated to "4001" and "1420", additional manufacturer narrative: three attempts were sent to the initial reporter to obtain more information in order to investigate and identify the root cause.No response was received from the initial reporter.(4112/213) the case has been reviewed by our corporate medical department whose assessment is below: "the event which precipitated this complaint is described as an open surgical carotid procedure where an intergard carotid patch was implanted on the left internal carotid artery.The complainant reported diffuse bleeding through the patch itself (ie not along the suture line) which required manual compression for several minutes, protamine administration, use of surgicel and the application of an additional patch (on top of the original patch).These reported measures to achieve hemostasis prolonged the surgical procedure and anesthesia time for the patient.There were no other patient complaints or adverse outcomes mentioned.As the original patch was left in place, there is no product to be returned and analyzed.A review of the device history record did not reveal a nonconformance issue.A limited amount of graft blushing would not be unusual during a carotid endarterectomy procedure, however after reversal of heparin and manual compression, it would be expected that the blushing would dissipate.The cause could be multifactorial and may be related to coagulation parameters, however because of the limited information provided, it is impossible to comment further on possible causes for the bleeding." (4110/213) occurrence of bleeding events is reviewed monthly during quality meeting, as per our internal procedure.During last meeting ((b)(6) 2022), the bleeding rate on intergard / hemagard products was within the maximum anticipated by the product risk assessment.(4315 - 50) no conclusion can be drawn on the exact origin of the adverse event since the product remained implanted and that the defect could not be reproduced/confirmed through the analysis of a retention sample.The conducted investigation concludes that the product was not defective at the time of manufacturing.However, based on medical assessment, the cause of the bleeding could be multifactorial and may be related to patient's coagulation parameters.
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