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Catalog Number 25MJ-501 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2023 |
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) 2023, a 25mm sjm masters series mechanical heart valve mitral was selected for an implant.A rubber hose was used to test leaflet function.After implantation, the physician found that the valve leaflet opened and closed abnormally, and then replaced with a new 25mm sjm masters series mechanical heart valve mitral.The leaflets were moving normally when tested post explant.The patient is stable and was treated with warfarin sodium.
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Manufacturer Narrative
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An event of a valve opening and closing abnormally after implantation was reported.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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Search Alerts/Recalls
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