EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A21 |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)
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Patient Problem
Dyspnea (1816)
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Event Date 11/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a 21mm 11500a aortic valve was explanted after an implant duration of four (4) years, ten (10) days due to pannus, immobile leaflet with severe as, and moderate regurgitation.Per medical records, the patient presented with sob and fatigue.The patient underwent redo- avr, ascending and aortic root replacement with a 24mm homograft.Intraoperatively, there was minimal mobility of right coronary cusp and substantial pannus beneath the valve.The patient tolerated the procedure well and was transferred to the icu in stable but critical condition.Per information received, there was fused immobile leaflet with severe as and ai.Pannus was located below the valve that contributed to the gradient and sub valvular jet.The physician curious if the jet could have contributed to the fusion.
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Manufacturer Narrative
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The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause of the reported pannus is patient factors.As reported, the reported pannus contributed to the reported stenosis; therefore, the most likely root cause of the reported stenosis is patient factors.
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