Model Number 7300TFX |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Endocarditis (1834); Insufficient Information (4580)
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Event Date 01/26/2024 |
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 27mm 7300tfx mitral valve was explanted after an implant duration of 3 years, 9 months due to unknown reason.The explanted valve was replaced with a 33mm 11400m valve.The patient was in recovery post procedure.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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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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Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patient's body and is not in any way related to the sterilization or packaging process of the device.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
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Event Description
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It was learned through implant patient registry and investigation that a patient with a 27mm 7300tfx mitral valve was explanted after an implant duration of 3 years, 9 months due to streptococcus mitis endocarditis with dehiscence, pvl, and severe insufficiency.The explanted valve was replaced with a 33mm 11400m valve.Per medical records, the patient presented with flu like symptoms.Work-up revealed multiple small acute embolic infarcts, strep mitis, and vegetation on the mitral leaflets following dental procedure.The patient underwent a redo mvr with reconstruction of the mitral annulus.Intraoperative finds showed dehisced valve with a large paravalvular leak and vegetations.The valve was excised.After annular debridement a 33mm mitris valve was implanted and secured with cor-knots.The valve was tested and was competent with no pvl.The patient tolerated the procedure and transferred to icu in critical condition.
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Search Alerts/Recalls
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