The pipeline flex device as not returned for evaluation as it was implanted in the patient.The pipeline flex device performed as intended; as indicated by successful deployment of the device in the intended landing zone to treat an aneurysm located in the internal carotid artery (ica).No device issue was reported during the procedure.Hemorrhage is a known inherent risk of endovascular procedure and is documented in the pipeline flex instruction for use.In addition, the physician stated that there was no causal relationship between the hemorrhage and the pipeline treatment.The cause is unknown.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received report that 2 days post uneventful pipeline embolization procedure for an unruptured saccular cerebral aneurysm m easuring 16mm located in the internal carotid artery (ica) with a medtronic flow diverter device, the patient developed a hemorrhage distal to the target aneurysm.The distal and proximal landing zone was 4.9mm x 5.2mm.The patient was reported to be in a vegetative state.The patient had dual antiplatelet therapy (dapt) prior to the pipeline treatment and then was not placed on dapt until one week after the procedure.Two days after being placed on dapt, a hemorrhage occurred, and the patient was transferred to the hospital.The detail of treatment provided to the patient during transfer is not available.The physician stated that there was no causal relationship between the hemorrhage and pipeline treatment.The patient is currently symptomatic.
|