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 revealed that the patient had new onset seizure, thought to be related to their prior chronic encephalomalacia.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.There was no evidence the patient had a history of similar 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.This information was received from the destination therapy post approval study.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.
|