The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported perforation could not be determined.Moreover, the cause of the reported hypoxia appears to be cascading effect of the reported perforation.The reported perforation is listed in the mitraclip system instructions for use (ifu) and is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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This is filed to report perforation and hypoxia requiring intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.After the transseptal puncture was completed, the steerable guide catheter (sgc) was advanced through the septum into the left atrium.Upon advancing, a significant right to left shunt was noticed.The patient started to decompensate and was unable to keep oxygen levels high enough.The device was removed and the procedure was aborted.Intervention was completed immediately to treat the shunt.No additional information was provided.
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