Dehiscence.Device not returned.Additional manufacturer narrative: the explanted device was not returned to edwards for analysis because it was discarded at the hospital.However, the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Without return of the device, edwards is unable to conclusively determine the root cause for this event.Ring dehiscence may occur early or late.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.No further actions are possible with the available information.
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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 ring was explanted after an implant duration of seven (7) years.Through follow up with the health care provider, it was learned that the reason for explant was due to regurgitation secondary to dehiscence following a ruptured chordae.This was replaced with a 28 mm edwards annuloplasty ring.The patient was in critical, but stable condition at the end of the procedure.
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