The pipeline device remained inside the patient, therefore, no product evaluation will be performed.Based on the reported information, the clinical observation dose not appear to be related to a device malfunction.However, the cause of the patient event could not be conclusively determined with the available information.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received information that a patient expired 15 days status post pipeline implant for treatment of a cerebral aneurysm at mca measured 8mm x 7mm.It was reported the pipeline device was prepared as indicated in the ifu.During the flow diversion procedure, no product issue was encountered.The pipeline was place at left mca bifurcation.The patient had a successful pipeline implant as evident by post op imaging.This patient had prior history of a-fib and had been on antiplatelet therapy.Prior to the pipeline implant procedure, patient did not have any neurological deficit.Besides a groin hematoma formation that required application of a fem stop and massage, there were no other perioperative events.Patient was discharged from the hospital on the following day at baseline with no neurological deficits.The patient's post flow diversion triple antiplatelet therapy (tapt) was managed in consultation with a cardiologist and a pharmacist.Patient was diagnosed with intracranial hemorrhage by ct scan at a different hospital on the day she expired.
|