Model Number 23AGFN-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 09/14/2022 |
Event Type
malfunction
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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 (b)(6) 2022, an sjm regent heart valve w/flex cuff was implanted.However the leaflet was unable to open and close normally due to an obstruction.The valve was explanted and the mechanical flap was replaced with another of the same brand and model.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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Event Description
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It was reported that on 14 september 2022, a 23mm sjm regent heart valve w/flex cuff was implanted.However the leaflet was unable to open and close normally due to an obstruction.The valve was explanted and the mechanical flap was replaced with another of the same brand and model.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.Subsequent to the previously filed report, additional information was received that the obstruction preventing the valve from opening and closing was the patient's native anatomy.The valve was explanted and replaced with another 23mm sjm regent heart valve w/flex cuff.
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Manufacturer Narrative
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The reported event the leaflets not coapting could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.Information from the field indicated that the leaflet was unable to open and close normally due to patient anatomy.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 but could have been due to an obstruction caused by the patient anatomy.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Search Alerts/Recalls
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