Model Number 19AHP-105 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Aortic Valve Stenosis (1717); Mitral Valve Stenosis (1965)
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Event Date 02/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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Related manufacturer reference : 3005334138-2022-00095.It was reported that a 19mm and a 27mm mechanical heart valve hemodynamic plus was implanted in 1997 for a double valve replacement due to aortic and mitral stenosis.The 19mm sjm mechanical heart valve was implanted in an aortic position and the 27mm sjm mechanical heart valve was implanted in a mitral position.During follow up period, recurrence of aortic stenosis and mitral stenosis was observed since 2010.The patient was being monitoring continuously though, ambulation difficulty occurred since (b)(6) 2021.The redo mitral valve replacement (mvr) and aortic valve replacement (avr) were conducted on (b)(6) 2022.Pannus was proliferated and extended over the leaflets though, no issue for leaflet mobility was confirmed.After the explant, a 27mm sjm epic valve was implanted and unknown valve was implanted in aortic position.The patient has been recovering after the surgery and has been in stable condition.No additional information was provided.
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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Related manufacturer reference : 3005334138-2022-00095.It was reported that a 19mm and a 27mm mechanical heart valve hemodynamic plus was implanted in 1997 for a double valve replacement due to aortic and mitral stenosis.The 19mm sjm mechanical heart valve was implanted in an aortic position and the 27mm sjm mechanical heart valve was implanted in a mitral position.During follow up period, recurrence of aortic stenosis and mitral stenosis was observed since 2010.The patient was being monitoring continuously though, ambulation difficulty occurred since (b)(6) 2021.The redo mitral valve replacement (mvr) and aortic valve replacement (avr) were conducted on (b)(6) 2022.Pannus was proliferated and extended over the leaflets though, no issue for leaflet mobility was confirmed.After the explant, a 27mm sjm epic valve was implanted and unknown valve was implanted in aortic position.The patient has been recovering after the surgery and has been in stable condition.No additional information was provided.
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Manufacturer Narrative
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An event of a stenosis, "ambulation difficulty", and pannus 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 cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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