Model Number 11400M |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2024 |
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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Edwards received notification that this valve model 11400m29m implanted in the mitral position was explanted from a 67-year-old patient after an implant duration of two (2) months and twenty-seven (27) days for unknown reason.As reported, reason for explant was not due to the device.Another valve of same model and size was implanted in replacement.
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Manufacturer Narrative
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Manufacturer narrative: updated section b5 as further review, model ref was updated from 11400m29m to 11400m29: "edwards received notification that this valve model 11400m29 implanted in the mitral position was explanted from a 67-year-old patient after an implant duration of two (2) months and twenty-seven (27) days for unknown reason.As reported, reason for explant was not due to the device.Another valve of same model and size was implanted in replacement." the serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The device was not returned for evaluation, no details regarding what issue warranted the intervention, or what comorbidities the patient had, were provided.Attempts to retrieve the device and additional information were unsuccessful.The cause of the event cannot be determined.
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Event Description
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Edwards received notification that this valve model 11400m29 implanted in the mitral position was explanted from a 67-year-old patient after an implant duration of two (2) months and twenty-seven (27) days for unknown reason.As reported, reason for explant was not due to the device.Another valve of same model and size was implanted in replacement.
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Search Alerts/Recalls
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