Catalog Number 23AHP-105 |
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 12/26/2023 |
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 23mm master's hemodynamic plus mechanical aortic valve was chosen for implantation.After implantation, the leaflets were immobile.A replacement 23mm masters hemodynamic plus mechanical aortic valve was implanted successfully.The explanted device was tested outside of the patient and the leaflets were still not functioning normally.The patient remained on cardiopulmonary bypass (cpb) throughout the procedure.There was reportedly a delay without patient effects.The patient is reported to be stable.
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Manufacturer Narrative
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An event of explant due to leaflet immobility was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Event Description
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It was reported that on 26 december 2023, a 23mm master's hemodynamic plus mechanical aortic valve was chosen for implantation.The patient presented with aortic stenosis.After implantation, the leaflets were immobile.Leaflet function was tested with a leaflet tester tool.A replacement 23mm masters hemodynamic plus mechanical aortic valve was implanted successfully.The explanted device leaflets was tested outside of the patient with the valve tester and the leaflets were still not functioning normally.The patient remained on cardiopulmonary bypass (cpb) throughout the procedure.There was reportedly a delay without patient effects.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.
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Search Alerts/Recalls
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