On (b)(6) 2019, a mitral valve repair with a memo 3d-rechord was performed.The implant of the ring was performed using the horizontally mattressed 2-0 ticron circumferentially.On (b)(6) 2019, ring dehiscence was detected through the echo.The patient was admitted to the icu (diagnosis: congestive heart failure, nyha class ii) and then transferred to the cleveland clinic, where a mitral valve replacement was performed (exact date of surgery unknown).Following the second surgery, the patient had a brain bleed with left-sided weakness.Based on the physician's assessment, a potential contributory factor to the reported dehiscence could be identified in the stitching area, which was reportedly very thin.
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A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the manufacturer was unable to follow up on the device disposition after the explant, no device inspection can be performed at this time.Based on the information available, it is not possible to establish the root cause of the event.However, based on the document review, no manufacturing nor quality deficits were identified.
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