Catalog Number 21AGFN-756 |
Device Problems
Physical Resistance/Sticking (4012); Central Regurgitation (4068)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 11/28/2023 |
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 that on 11 september 2023, a 21mm regent aortic mechanical valve was implanted successfully.After implantation on (b)(6) 2023, it was reported that the blood flow was unstable in the opinion of the cardiac surgeon.There was central regurgitation and the leaflets would not open evenly on both sides.The patient was reported to be stable and under monitoring.
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Manufacturer Narrative
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An event of central regurgitation and the leaflets would not open evenly on both sides was reported.A more comprehensive assessment, including hydrodynamic testing to evaluate valve function could not be performed as the device remains implanted and 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.A fluoroscopy video showed the opening and closing of the 21 mm regent valve.Both leaflets opened and closed symmetrically.The opening angle was nominal (85 degrees) and the closing angle was nominal (120 degrees).There appeared to be some asymmetry of the area outside the carbon housing, but this may be related to the angulation used to perform the imaging.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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