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, it was reported that a (b)(6) male underwent a ring explant after an implant duration of approximately three (3) weeks.Through follow up with the health care provider, it was learned that the reason for explant was due to severe mitral regurgitation and anterior dehiscence of 4 sutures of the mitral valve ring.The ring was explanted and replaced with a 27mm carpentier-edwards duraflex low pressure mitral bioprosthesis.There were no complications during the procedure and the patient was subsequently transferred to the intensive care unit.
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Dehiscence.Method: device not returned.Additional manufacturer narrative.The explanted device was not returned to edwards for analysis because it was discarded at the hospital.Without return of the device, edwards is unable to conclusively determine the root cause for this event.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair or prosthetic valve implantation in combination with friable myocardial tissue.No further actions are possible with the available information.
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