It was reported that a patient with a 21mm 11500a insipiris valve was scheduled for a tavr procedure after an implant duration of two (2) years, nine (9) months due to severe aortic stenosis.It was then noted that the patient was too sick to proceed with the tavr per the physician team.Upon induction of anesthesia, the patient experienced a bradycardic arrest with profound hypotension and hypoxia requiring cpr.The patient had ongoing respiratory failure, bradycardia, and cardiac arrest and later expired with an unspecified cause of death.There was no allegation by the physicians that the 21mm 11500a inspiris valve caused or contributed to the patient's death.
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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.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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The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.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 coronary artery disease (cad), coronary artery bypass graft (cabg) and end stage kidney disease (esrd) on dialysis.
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