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, edwards received information that this device was explanted after eleven (11) years, five (5) months due to aortic insufficiency, secondary to degeneration.Upon clinical observation, one leaflet had torn from its post and was prolapsing into the outflow tract of the left ventricle.The leaflets were somewhat thickened but there was no significant calcification.This was excised and replaced with a 21mm pericardial bioprosthetic with no complications.The patient was transferred from the or to the icu in stable but critical condition and is noted to be "discharged home and doing well.".
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Leaflet prolapse.Thickened leaflet.Method: device not returned: additional manufacturer narrative:leaflet tears and leaflet disruptions occurring over time are a form of structural valve deterioration that may ultimately result in significant regurgitation requiring replacement of the valve.The explanted device was not returned to edwards for analysis.Without return of the device, edwards is unable to confirm the clinical observation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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