Model Number 11500AJ |
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 08/24/2023 |
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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Edwards received information through its implant patient registry that a 25mm 11500aj aortic valve was explanted after a duration of two (2) years due to unknown reason.Another same model 25mm 11500aj aortic valve was implanted in replacement.No information about device return at this moment.File will be updated.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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A device history record (dhr) review is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.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.The most likely cause is patient factors.H11 corrected data: based on the additional information, this event is no longer considered reportable.
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Event Description
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Edwards received information through its implant patient registry that a 25mm 11500aj aortic valve was explanted after a duration of two (2) years due to infective endocarditis.Another same model 25mm 11500aj aortic valve was implanted in replacement.The device was not returned for evaluation due to infection.Type and source of infection were not reported.There was no allegation of device malfunction.
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Search Alerts/Recalls
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