The device will not be returned for evaluation as it was implanted in the patient; therefore without return of the device, no definitive conclusions can be drawn regarding the clinical observation.The event occurred in the patient post procedure and its cause was unknown.Attempts were made to obtain additional information, however, no further information was provided.User context may have contributed to this event.Pipeline embolization device instruction for use provided this instruction, "after the entire ped is deployed, advance the micro catheter through the ped making sure not to dislodge the ped." same event as reported in mdr mfr: 2029214-2016-00242.
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