Model Number 11500A |
Device Problem
Gradient Increase (1270)
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Patient Problem
Chest Pain (1776)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that a patient with a 21mm 11500a aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 2 years, 11 months due to stenosis.The patient presented with chest pain.No planned intervention at this time.
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Event Description
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It was reported that a patient with a 21mm 11500a aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 2 years, 11 months due to stenosis and halt.The patient presented with chest pain.No planned intervention at this time.
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Manufacturer Narrative
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Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
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Search Alerts/Recalls
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