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.In this case a 26mm bioprosthetic mitral ring implanted approximately one (1) month and sixteen (16) days was explanted due to endocarditis/dehiscence.The explanted device was replaced with a 25mm bioprosthetic ring.It was further learned that the patient expired after implantation."alleged drug use" was reported and cause of death is unknown.No additional details were provided.
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(b)(4).Method: device not returned.The device was not returned to edwards for analysis.Device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Without the return of the device, edwards is unable to confirm the clinical observation.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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