Model Number 21AGFN-756 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020, a 21 mm regent heart valve was selected for implant.While placing the valve the physician adjusted the direction of the leaflet and it fell off.The valve was replaced with a 19 mm regent heart valve and due to the need of a new valve there was a clinically significant delay in procedure.The patient was report to be in stable condition.
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Manufacturer Narrative
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The reported event of a dislodged leaflet was confirmed.Both leaflets were dislodged from the orifice, with one leaflet returned with the valve.That leaflet was fractured, and one pivot guard was damaged.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment and fractured pivot guard could not be conclusively determined.
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Search Alerts/Recalls
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