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Catalog Number 25AGFN-756 |
Device Problem
Device Stenosis (4066)
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Patient Problems
Aortic Valve Stenosis (1717); Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)
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Event Date 08/11/2023 |
Event Type
Injury
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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) 2023, a 25mm sjm regent heart valve with flex cuff was chosen for implant for an aortic valve replacement.At the time of device preparation, the leaflets were moving normally when tested using a blue leaflet tester.After the device was implanted and the patient was removed from bypass, it was noted that the aortic valvular gradient was 40mmhg.On transesophageal echocardiogram (tee), both leaflets appeared to be functioning.The patient was placed on bypass again, and the valve was explanted and replaced with a 23mm non-abbott valve.Following the procedure, the patient had mild right ventricular dysfunction and pneumonia, and the hospitalization was extended.The patient status was stable.
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Manufacturer Narrative
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An event of a valve not functioning as intended was reported.One video was received from the field appearing to show the testing of the valve leaflets.The valve was returned to abbott for analysis and the investigation found that both leaflets were able to fully open and close with no resistance occurring.Leaflet function was considered normal with both leaflets opening while having no asynchronous motion or leaflet malfunction.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 reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Event Description
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It was reported that on (b)(6) 2023, a 25mm sjm regent heart valve with flex cuff was chosen for implant for an aortic valve replacement.At the time of device preparation, the leaflets were moving normally when tested using a blue leaflet tester.After the device was implanted and the patient was removed from bypass, it was noted that the aortic valvular gradient was 40mmhg.On transesophageal echocardiogram (tee), both leaflets appeared to be functioning.The patient was placed on bypass again, and the valve was explanted and replaced with a 23mm non-abbott valve.After the valve was explanted, the leaflet function was tested again.It was noted that one of the leaflets had resistance with movement.Following the procedure, the patient had mild right ventricular dysfunction and pneumonia, and the hospitalization was extended.The patient status was stable.
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Search Alerts/Recalls
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