Model Number PVS21 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 09/08/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, a perceval sutureless aortic heart valve, pvs21 was implanted and explanted due to confirmed leak.A new pvs21 was eventually implanted instead.No further details are provided at this time.
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Manufacturer Narrative
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The manufacturing and material records for the perceval heart valve, model # icv1208, (b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model # icv1208 perceval heart valve at the time of manufacture and release.Unknown disposition.
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Manufacturer Narrative
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Manufacturer was informed that no further information will be provided.Based on the limited information available, the definitive cause of the reported event cannot be established at this time.However, no material deficits were identified from the production records review.Since no other investigation can be performed, the case will be considered closed at this time.Should new information be received in the future, a follow up report will be provided.
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Search Alerts/Recalls
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