The surgeon reported to gore that the patient experienced inflammation on the skin surface above the gore propaten® vascular graft.The surgeon communicated he believes the inflammation is related to the luminal surface coating of the graft.Additional information received by gore reported the following: "pt developed severe hypersensitivity reaction 7-10 days after placement of right forearm gore propaten® vascular graft.Symptoms included significant erythema, edema, and tenderness along the tunneled tract.Unfortunately he [the patient] also developed steal syndrome and subsequent right hand ischemia unrelated to the reaction.Therefore we opted to excise the graft.Pt had immediate improvement in hypersensitivity reaction.".
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Review of the manufacturing and sterilization records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Based on the investigation, we are unable to determine the exact cause(s) of this event.
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