Model Number 25AGFN-756 |
Device Problems
Perivalvular Leak (1457); Physical Resistance/Sticking (4012)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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It was reported a 25mm regent aortic mechanical heart valve was chosen for procedure on (b)(6) 2022.During the procedure after the patient came off cardiopulmonary bypass (cpb) a transesophageal echocardiogram (toe) was performed which revealed a significant a leak.It appeared the inside sewing ring and one of the leaflets was stuck and was not moving normally.The patient was re-opened and the valve was inspected.The problem with the valve was not clearly identified.The physician rotated the valve and closed the patient was closed again.The toe was repeated which revealed a severe leak was still present.The decision was made to explant the valve and a new unknown size regent aortic mechanical heart valve was implanted.Another toe was performed revealing the valve was seated and functioning as intended with no leaks.The patient remained stable throughout the procedure and was discharged from the hospital 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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Manufacturer Narrative
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An event of significant leak and one of the leaflets being stuck was reported.A returned device assessment could not be performed as the device 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.Based on the information received, the cause of the reported incident could not be conclusively determined.H6.Medical device problem code: code 1457 perivalvular leak was removed.
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Event Description
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N/a.
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Manufacturer Narrative
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An event of significant leak and one of the leaflets being stuck was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.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.
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Event Description
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N/a.
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Search Alerts/Recalls
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