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); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Dyspnea (1816)
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Event Date 03/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 and learned through medical records that a patient with a 27mm 11500a aortic valve, implanted in the pulmonic position, underwent a valve-in-valve procedure after an implant duration of 2 year due to severe stenosis and regurgitation secondary to leaflet thrombus/halt.The patient presented with dyspnea, fatigue, and chest pain.The procedure was performed successfully with a 9750tfx 26mm transcatheter valve.Per medical records, the patient presented with severe bioprosthetic pulmonary valve regurgitation and mild-mod tr admitted to the hospital for elective tpvr.The patient underwent an uncomplicated transcatheter valve procedure and was discharged home on pod #1.
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Manufacturer Narrative
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The device history record (dhr) could not be reviewed, as the device serial number was not provided.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.There may be cases of incidental finding by imaging (echocardiography and/or ct scan) of subclinical leaflet thrombosis (halt) where the patient will benefit from a close follow-up and may be treated with oral anticoagulant.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.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.
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