Catalog Number 25AGFN-756 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2024 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6)2024, a 25mm sjm regent heart valve w/ flex cuff was chosen for a procedure.The valve was implanted.Immediately after the implant, it was noted that there was opening failure of the leaflet and the valve was explanted.A new 23mm sjm regent heart valve w/ flex cuff was implanted.The patient was reported 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 information.
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Manufacturer Narrative
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Explant due to leaflet opening failure was reported.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.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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