ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL
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Model Number 25CAVGJ-514 00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Hemorrhage/Bleeding (1888); Renal Failure (2041); Heart Block (4444)
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Event Date 03/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported on (b)(6) 2022, a 25mm masters series aortic valve was implanted.Post procedure, the patient experienced a drop in hemoglobin.Two units of red blood cells (rbc) were given on (b)(6) 2022, and two units of rbc were given on (b)(6)2022.The source of the bleeding was not provided.On (b)(6) 2022, the patient had an acute kidney injury with increasing creatinine while in the intensive care unit (icu).Diuretics were given as treatment.The patient also had new st-elevation in lead ii and atrial fibrillation noted on ecg.On (b)(6) 2022, a long-term electrocardiogram (ecg) noted extra systoles and intermittent av block ii.On (b)(6) 2022, a pacemaker was implanted to resolve this event.The patient was reported to be in stable condition.No additional information was provided.
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Manufacturer Narrative
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An event of of drop in hemoglobin, kidney injury, atrial fibrillation, st-elevation in lead ii, extra systoles and intermittent av block ii were reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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