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Catalog Number E100-33M-00 |
Device Problem
Central Regurgitation (4068)
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Patient Problem
Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 02/22/2024 |
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) 2024, a 33mm epic mitral valve was chosen for implant.The patient was presented with a non-abbott annuloplasty ring that was placed 10 years ago.During the procedure, the epic valve was implanted, using a total of 27 stitches.After coming off cardiopulmonary bypass, the patient was found to have mild central mitral valve regurgitation (mr).Considering the additional risks for replacing the implanted valve, a decision was made to not explant the valve although the presence of mild mr was considered unacceptable.The patient was reported to be discharged.The mr prior to discharge was observed to be at grade mild-trace.
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Event Description
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It was reported that on 22 february 2024, a 33mm epic mitral valve was chosen for implant.The patient was presented with a non-abbott annuloplasty ring that was placed 10 years ago.During the procedure, the epic valve was implanted, using a total of 27 stitches.After coming off cardiopulmonary bypass, the patient was found to have mild central mitral valve regurgitation (mr).Considering the additional risks for replacing the implanted valve, a decision was made to not explant the valve although the presence of mild mr was considered unacceptable.The patient was reported to be discharged.The mr prior to discharge was observed to be at grade mild-trace.
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Manufacturer Narrative
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An event of mild central mitral valve regurgitation post implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, to see if there were any valve abnormalities could not be performed as the device remains implanted and 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, including functional testing prior to release form abbott.This test ensures proper cuspal coaptation and hemodynamic performance.Based on the information associated with this complaint, the exact cause of the reported event could not conclusively be determined.
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Search Alerts/Recalls
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