EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Incomplete Coaptation (2507)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); Peripheral Edema (4578)
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Event Date 04/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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Additional narratives surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a patient with a 23mm valve implanted in the pulmonic position underwent a valve-in-valve procedure after an implant duration of 6 months due to mild stenosis, moderate insufficiency, and incomplete coaptation.A 23mm transcatheter valve was implanted.Per medical records, the patient presented with heart failure and peripheral edema.The cardiac workup showed tilted appearance of the bioprosthetic pulmonary valve with mild-moderate insufficiency, mild stenosis, and incomplete coaptation of leaflets.The patient underwent pulmonary stenting and pvr with a 23mm sapien 3 valve.Post procedure echo showed bioprosthetic pulmonary valve is well-seated, has good function without stenosis or pvl, and has trivial regurgitation.The patient was transferred to picu.
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Manufacturer Narrative
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Based on the information provided, a definitive root cause could not be determined.However, patient factors, including patient age at time of implant, likely caused or contributed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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