This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.Product event summary: (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient was hospitalized for melena and a gastrointestinal (gi) bleed; the patient received a blood transfusion and an argon plasma coagulation was performed.Based on the limited information available, the device may have caused or contributed to the reported event.Per the instructions for use, gi bleeding is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of bleed 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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