The subject device was not explanted at the time of the event.Customer report of paravalvular leak could not be confirmed by product evaluation.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The subject device was replaced through a valve-in-valve procedure on (b)(6) 2022 (medwatch #24595).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.
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Edwards received notification that severe paravalvular leak was observed on this valve model: 7300tfx27 implanted in mitral position after an unknown implant duration.As reported, there was a large paravalvular leak in the posteromedial location and a prolapse of the lateral prosthetic cusp.The patient was experiencing dyspnea.The patient was readmitted to hospital and underwent surgical repair.The device was not explanted at that time.As reported, no pvl was observed during intraoperative or soon post-operative echo.
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Updated g3, h6.H10: additional narrative: regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.In this case, based on available information a definitive root cause cannot be conclusively determined; however, patient and or procedural factors likely caused or contributed.
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