It was reported that post implant the patient had a suspected gastrointestinal (gi) bleed, with a drop in hemoglobin/hematocrit from 8.5/24.9 to 6.9/20.7.The patient also had melena and anemia.Gastroenterology was consulted and upper gi endoscopy was performed which showed no evidence of bleeding.The patient was transfused one unit of packed red blood cells (prbcs) after values for hemoglobin and hematocrit were 7.1/21.5 and the day after 7.8/23.Treatment consisted of stents, oral anticoagulants, and ferrous gluconate to address the anemia.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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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: hw40121 was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient had a suspected gastrointestinal (gi) bleed, melena, and anemia; however, an upper gi endoscopy showed no evidence of bleeding.The patient received a blood transfusion and was treated with stents, oral anticoagulants, and ferrous gluconate to address the anemia.Based on the available information, including the occurrence of the event within 30 days of implant, 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 prior 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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