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Model Number 11400M |
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 11/03/2023 |
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 25mm 11400m mitral valve was explanted after an implant duration of 6 months, and 15 days due to unknown reasons.Unknown what valve was implanted in replacement.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 investigation that a patient with a 25mm 11400m mitral valve was explanted after an implant duration of 6 months, and 15 days due to staphylococcus epidermidis endocarditis.The mitral valve was replaced with a 25mm non-edwards mechanical valve.Per medical records, the patient presented with symptoms of stroke, work-up revealed staph epi bacteremia, severe acute endocarditis of both mitral and aortic valves.Patient underwent emergent redo mvr and avr with patch reconstruction of aortic root, aortomitral curtain and lvot, and aortic patch repair.There was vegetation on both valves and large abscess in the fibrous curtain with extensive destruction.Both valves were replaced with st jude's mechanical valves.Post procedure echo showed valve function was normal with no pvl.The patient was transported in stable condition to the cticu.On pod #23, the patient was discharged.Hospital pathology report: aortic and mitral prosthesis with acute inflammation, giant cell reaction, overlying fibrin, and associated gram positive cocci, consistent with an active bacterial endocarditis.
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Manufacturer Narrative
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The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore, no device history record (dhr) is required.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset at 60 days or less postimplant) and late (onset greater than 60 days post-implant).Early-onset generally reflects contamination arising in the perioperative period; if there were ever non-conformances in the sterility or packaging processes, they would most likely manifest at this time.Late-onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.In this case the onset was greater than 60 days post-implant.H11 corrected data: based on the additional information, this event is no longer considered reportable.
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Search Alerts/Recalls
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