H10: additional manufacturer narrative: the subject device is not available for evaluation, as it remains implanted in the patient.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.
|
H10: additional manufacturer narrative: updated sections: h6 (clinical code, type of investigation, investigation findings, and investigation conclusions).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.Engineering evaluation summary: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potentials known and unknown patient-related contributing factors.Per technical summary (b)(4), structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis 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 a history of coronary artery disease and atherosclerosis.H11: corrective data: section h6: clinical codes were inadvertently omitted when submitting the initial medwatch# 33072.The section has been updated accordingly and this correction is being submitted.All pertinent information available to edwards lifesciences has been submitted.
|
It was reported that a model 11500a 25mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 3 years, 9 months due to stenosis and ai.The patient presented with heart failure, shortness of breath, and chest pain.A 9755rsl 26mm transcatheter valve was successfully implanted.
|