EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 11500A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/20/2024 |
Event Type
Injury
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Manufacturer Narrative
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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 learned through implant patient registry that a patient with a 23mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to unknown reasons.The explanted valve was replaced with a 25mm 11500a.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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Event Description
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It was learned through implant patient registry and medical records that a patient with a 23mm 11500a aortic valve was explanted after an implant duration of 2 years, 2 months due to endocarditis.The explanted valve was replaced with a 25mm 11500a.The patient tolerated the procedure well and was transferred to icu in stable condition.The patient was discharged pod #6.Per medical records, the patient presented with endocarditis.Tee revealed a poorly visualised echodensity beneath prosthetic valve in the lvot and echo indecies showed at least moderate stenosis.The patient underwent redo sternotomy, avr, and cabg.A small vegetation on the prosthetic aortic valve leaflets and large sub valvular vegetations were found.After explanting the infected valve, a 25mm 11500a inspiris resilia aortic valve was implanted.There were no apparent complications and the patient tolerated the procedure well.The patient was transferred to icu in stable condition.The patient was discharged from the hospital on pod# 6.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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H11: additional manufacturer narrative: updated section b5.H11: corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
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