It was reported and per investigation that a patient with a 25mm 7300tfx mitral valve under a valve-in-valve procedure after an implant duration of 6 years, 9 months due to medial and lateral leaflets fixed due to pannus formation with severe stenosis, mild central and paravalvular regurgitation.The patient presented with decompensated hfpef.The tmvr procedure was performed with a 26mm 9750tfx valve/commander delivery system.The patient was stable at the end of the procedure.
|
The subject device is not available for evaluation, as it remains implanted in the patient.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.
|
Component code, device code(s), type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.
|