This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information provided by the site indicated that two months after the ventricular assist device (vad) implant procedure, the patient experienced an embolic stroke.A computerized tomography angiography (cta) confirmed acute thrombotic occlusion of the left middle cerebral artery m1 segment.A mechanical thrombectomy was attempted which led to hemorrhagic conversion.The patient was hospitalized.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, stroke and thromboembolism are known potential complications associated with the implantation of a vad.There was no evidence the patient had a history of similar adverse events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
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