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Model Number 11500A |
Device Problems
Gradient Increase (1270); Difficult to Open or Close (2921)
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Patient Problems
Dyspnea (1816); Fatigue (1849)
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Event Date 12/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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It was reported that a patient with a 23mm 11500a inspiris aortic valve demonstrated severe stenosis due to reduced leaflet mobility after one (1) year and 8 months.The patient presented with progressive sob and fatigue.The patient is being monitored and evaluated for tavr procedure.Per medical records and customer report, the patient had increasing elevated gradient starting three (3) months.At one (1) year, and eight (8) months tee showed severe aortic stenosis, trace insufficiency, and high gradient with a mean of 40mmhg.At one (1) year, nine (9) months tee demonstrated slightly reduced excursion of the leaflets with uniform opening without evidence of clot or vegetation, and no ai.It was recommended that the patient take anticoagulation for three (3) months, but patient refused.
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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.There were no issues identified that would have impacted this event.Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.All pertinent information available to edwards lifesciences has been submitted.
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Search Alerts/Recalls
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