Catalog Number 19AGFN-756 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2023 a 19mm sjm regent heart valve was implanted in a patient.During the procedure the valve lobe fell off when the valve was rotated.The two leaflets dislodged as one piece and was recovered from the patient.Therefore, the surgeon removed the sutures and replaced another 19mm sjm regent heart valve that successfully completed the procedure.The patient is stable.
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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 informationna.
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Event Description
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It was reported that on (b)(6) 2023 a 19mm sjm regent heart valve was implanted in a patient.During the procedure the valve lobe fell off when the valve was rotated.The two leaflets dislodged as one piece and was recovered from the patient.Therefore, the surgeon removed the sutures and replaced another 19mm sjm regent heart valve that successfully completed the procedure.The patient is stable.
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Manufacturer Narrative
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The reported event of a dislodged leaflets was confirmed.Both leaflets were dislodged from the orifice and returned with the valve.One of the dislodged leaflets was found to be improperly inserted into the orifice in an upside-down position.No other damages or anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Two photographs from field appeared to show a mechanical valve having one leaflet dislodged from orifice while the other one was out of place within valve.The cause of the leaflet dislodgment could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that the valve was in open position when rotated.Please note that per the instructions for use, "precautions: to avoid structural damage, the valve must be rotated in the fully closed position.".
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Search Alerts/Recalls
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