Model Number 23VAVGJ-515 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
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Event Date 01/09/2023 |
Event Type
Injury
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Event Description
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Clinical study patient id: (b)(6) ((b)(6),(b)(6)).It was reported that on (b)(6) 2023, a 23mm sjm masters series valsalva aortic valved graft was implanted into a patient.The patient had a high amount of blood drainage post operatively for 30 minutes.Surgical intervention was performed and 3 units of blood and blood products given.On (b)(6) 2023, the patient have elevated c-reactive protein and leukocytosis.An unspecified infection is suspected and medication was administered.No patient consequences were reported.No additional information was provided.
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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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Manufacturer Narrative
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An event of bleeding, elevated c-reactive protein, leukocytosis and unspecified infection was 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Search Alerts/Recalls
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