It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 and flail.A mitraclip xtw was inserted, and grasping was performed.However, the leaflets were unable to be grasped.An echocardiogram was performed and revealed that the posterior flail had become wider, and it was suspected that a new chord or leaflet tear occurred while grasping the leaflets.Therefore, the clip was removed from the patient, and the procedure was aborted.The mr remained at a grade of 4.The patient was transferred to coronary care unit (ccu) for observation and assessment and was reported to be medically managed.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and the reported positioning failure associated with leaflet capture per the account was related to patient conditions associated with leaflet quality.Unspecified tissue injury appears to be related to procedural conditions associated with leaflet capture related issue.Tissue damage is a known possible complication associated with mitraclip procedures.Medication required was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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