H10: additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.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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Edwards received notification that an inspiris resilia valve model 11500a21 was explanted from the aortic position after an implant duration of four (4) years due to degeneration at the level of the right and left coronary cusps leading to moderate stenosis and high gradients (mean gradient of 36mmhg and peak gradient of 65mmhg, max velocity 4 m/s) and mild insufficiency with central jet.Reportedly, this 51-year-old patient presented with worsening dyspnea and reported weight gain with edema.A 23mm edwards valve was implanted in replacement.Patient was noted as to be in good condition.
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As per further information provided, added information to d4 serial number, e1 reporter name and address, section h6 (component code).Updated section b5 (describe event or problem).Section h6 (device code ) updated from 1153 - degraded to 1077 - calcified.
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Edwards received notification that an inspiris resilia valve model 11500a21 was explanted from the aortic position after an implant duration of four (4) years due to early calcific degeneration at the level of the right and left coronary cusps leading to hypomobile leaflets, severe stenosis with high gradients (mean gradient of 36mmhg and a peak gradient of 65mmhg, max velocity 4 m/s) and mild insufficiency with central jet.Reportedly, this 51-y-o patient presented with worsening dyspnea and reported weight gain with edema.A 23mm edwards valve was implanted in replacement.Patient was noted as to be in good condition.
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H3 device evaluation: the device was returned for evaluation.Customer reports of calcification, leaflet mobility issue and stenosis were confirmed.The x-ray demonstrated the wireform was bent outward at commissure 1, cocr band was intact and the vfit cocr alloy band was not expanded.X-ray demonstrated heavy calcification on leaflet 1, moderate calcification on leaflet 3 and minimal calcification on leaflet 2.Extrinsic calcific deposits were observed on the surface of leaflet 1, leaflet 3 cusp and next to sewing ring on leaflet 3 at the outflow aspect.Leaflet 1 had a 5mm x 2mm hole near commissure 1, a 3mm x 2mm hole near commissure 2 and a 4mm tear at cusp.Calcification was evident at the holes and tear.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 at the inflow aspects.Host tissue overgrowth on the stent circumference was minimal on the inflow and outflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing cloth had multiple cuts and exposed the metal band on the inflow aspect.H10 manufacturer narrative: the manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including including diabetes and chronic kidney disease.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.The most likely cause is patient factors.
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