Model Number 25MECJ-502 |
Device Problems
Incomplete Coaptation (2507); Patient-Device Incompatibility (2682)
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Patient Problem
Mitral Valve Stenosis (1965)
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Event Date 08/10/2022 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2022, a sjm masters series valve with expanded cuff was successfully implanted in a patient.On (b)(6) 2022, the patient returned for a routine follow up and was discovered to have mitral valve stenosis.The decision was made to explant the sjm masters series valve and replace it with a non-abbott device.The patient was stable at the time of report.
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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, a sjm masters series valve with expanded cuff was successfully implanted.On 10 august 2022, the patient returned for a routine follow up and was discovered to have mitral valve stenosis.A transesophageal echocardiogram (tee) was done, and it was observed that the valve was stiff and one of the leaflets was stuck.The decision was made to explant the sjm masters series valve and replace it with a 25mm non-abbott device.The patient was stable and discharged at the time of report.
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Manufacturer Narrative
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Explant due to the valve not being coapting properly and one of the leaflets being stuck was reported.The investigation found that both leaflets were intact and opened and closed completely but moved with difficulty.No material was seen within the pivot recesses or on the surfaces of the mechanical leaflets.The sewing cuff was intact.There was a patchy fibrous pannus formation on the sewing cuff which did not appear to impinge upon the mechanical components.No inflammation.Sections of material removed from the sewing cuff consisted of fibrous tissue consistent with pannus.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The limited leaflet mobility could lead to a number of potential issues with valve functionality.
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Search Alerts/Recalls
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