The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, the reported perforation resulting in hypoxia appears to be related to procedural conditions associated with the atrial septal puncture and possibly exacerbated by sgc insertion.Perforation is listed in the instructions for use (ifu) as a known possible complications associated with mitraclip procedures.Unexpected medical intervention 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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This will be filed to report hypoxia, atrial septal defect, requiring intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 3 with a prolapsed posterior leaflet.Shortly before inserting the clip delivery system (cds), the patient¿s saturation continued to fall and could not be stabilized.The procedure then had to be aborted, this happened due to the leading tr and the existing right-left shunt.After removing the steerable guide catheter (sgc), a septum occluder was implanted in the patient.There was no clinically significant delay in the procedure.No additional information was provided.
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