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Model Number 11400M |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Patient Device Interaction Problem (4001)
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Patient Problem
Heart Failure/Congestive Heart Failure (4446)
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Event Date 08/15/2023 |
Event Type
Injury
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Event Description
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It was learned through implant patient registry that a patient with a 33mm 11400m mitral valve, implanted in the tricuspid position, was explanted after an implant duration of 6 months due to severe tricuspid regurgitation, thrombus, and stenosis.The explanted valve was replaced with another 33mm 11400m mitral valve.Per the medical records, the patient presented with nyha class iii.The patient underwent a redo tvr with another 33mm 11400m valve and pfo closure.Intraoperatively, there appeared to be a clot and thrombus on the valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
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Manufacturer Narrative
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H10: additional manufacturer narrative: the subject device is not available for evaluation, as the device status is unknown at this time.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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Manufacturer Narrative
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H10: additional manufacturer narrative: updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event."it was learned through implant patient registry that a patient with a 33mm 11400m mitral valve, implanted in the tricuspid position, was explanted after an implant duration of 6 months due to severe tricuspid regurgitation, thrombus, and stenosis." 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.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.The most likely cause is patient factors.
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Search Alerts/Recalls
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