This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4).This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information provided by the site indicated that the patient was admitted for large bloody stools, and a colonoscopy revealed an actively bleeding rectal ulcer.The ulcer was packed and the bleeding stopped.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, bleeding is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of bleeding.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.
|