This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information received from the site indicated that the patient had melena onset and the next day melena with fresh blood was observed, two days later the patient was hospitalized.An esophagogastroduodenoscopy (egd) was conducted with no evidence of active bleeding, a coloscopy showed colon polyps with active bleeding on the sigmoid colon, a successful polypectomy was performed with clipping.The patient was transfused 2 packs or red blood cells (rbc) and one pack of fresh frozen plasma (ffp).It was further noted that the patient had positive urine cultures with no symptoms, a few hours later turbid and frequent urine were observed, and enterococcus faecalis was confirmed.Oral antibiotics were started for a course of 15 days.Based on the available information, the device may have caused or contributed to the reported event.Per the i nstructions for use, infection and bleeding are known potential complications associated with the implantation of a vad.Based on a review of past adverse events, it was noted that the patient had a history of infection 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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It was reported that the patient had melena onset and the next day melena with fresh blood was observed, two days later the patient was hospitalized.An esophagogastroduodenoscopy (egd) was conducted with no evidence of active bleeding, a coloscopy showed colon polyps with active bleeding on the sigmoid colon, a successful polypectomy was performed with clipping.The patient was transfused 2 packs or red blood cells (rbc) and one pack of fresh frozen plasma (ffp).It was further noted that the patient had positive urine cultures with no symptoms, a few hours later turbid and frequent urine were observed, and enterococcus faecalis was confirmed.Oral antibiotics were started for a course of 15 days.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.
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