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.
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It was reported a patient with a 23mm 11500a aortic valve, implanted in the pulmonary position, has been placed under evaluation for a valve-in-valve after an implant duration of two (2) years, seven (7) months due to significant stenosis of the rvot, and mild pulmonary insufficiency.
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It was reported a patient with a 23mm 11500a aortic valve, implanted in the pulmonary position, underwent a valve-in-valve after an implant duration of two (2) years, seven (7) months due to significant stenosis of the rvot, and mild pulmonary insufficiency.The procedure was performed with a 26mm 9750tfx valve.The patient tolerated the treatment and was discharged to the icu in stable condition.
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The device history record (dhr) review was completed and there were two non-conformances found related to this serial number.However, the valve was re-worked to completion, passing all inspections.Per the event description, "it was reported a patient with a 23mm 11500a aortic valve, implanted in the pulmonary position, underwent a valve-in-valve after an implant duration of two (2) years, seven (7) months due to significant stenosis of the rvot, and mild pulmonary insufficiency." based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.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.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 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.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
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