Model Number 11500AJ |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/05/2023 |
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 21mm 11500aj valve was explanted after a duration of one (1) years and four (4) months due to unknown reason.Another same model 21mm 11500aj 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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Event Description
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Edwards received information through its implant patient registry that a 21mm 11500aj valve was explanted after a duration of one (1) years and four (4) months due to unknown reason.Another same model 21mm 11500aj valve was implanted in replacement.No additional information was provided.
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Manufacturer Narrative
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A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, 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 device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Despite multiple requests for additional information from the healthcare provider, no additional details have been provided.Based on the information available, a definitive root cause cannot be conclusively determined.
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Search Alerts/Recalls
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