Catalog Number 21AGFN-756 |
Device Problem
Device Stenosis (4066)
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Patient Problems
Aortic Valve Stenosis (1717); Respiratory Insufficiency (4462)
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Event Date 11/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve with flex cuff was selected for an implant procedure in a patient with prior aortic stenosis and respiratory distress.It was noted during procedure that the valve had been oversized and would not enter the annulus fully, but the valve had already been sutured.It was noted that the event resulted in exacerbation of the patient's aortic stenosis and respiratory distress.The decision was made to remove and replace the 21mm sjm regent heart valve with flex cuff, with a 21mm epic supra valve to complete the procedure.There was no other treatment performed due to the patient's exacerbated aortic stenosis and respiratory distress.The patient was not taken off bypass due to this event.The patient was reported as stable at the time of report.
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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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The reported event was due to exacerbation of the patient's aortic stenosis and respiratory distress.It was also reported that the valve was oversized and would not enter the annulus fully, but the valve had already been sutured.The valve was explanted and no other treatment was performed.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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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