On (b)(6) 2021, the patient underwent a coil embolization procedure in the middle cerebral artery (mca)/ middle cerebral artery (mca) bifurcation using a neuron max 6f 088 long sheath (neuron max) and penumbra smart coils (smart coils).It was reported the patient had been previously treated for aneurysms.During the procedure, the neuron max was placed into the cervical right internal carotid artery (ica) using the roadmap technique, double flushed and connected to a continuous heparinized saline infusion.The patient had multiple vasospasms requiring 10mg ia in left vertebral artery and 5mg ia verapamil in right internal carotid artery (ica) and an additional 5mg.Balloon angioplasty was performed in m1 segment due to the vasospasms which were resolved on the same day.The vasospasm was reported to be a non-serious adverse event with a definite relationship to the index procedure and to the neuron max.During the procedure, the first smart coil was successfully implanted.While placing the second smart coil thrombus formation was noted.Half cardiac bolus dose of tirofiban was administered, and later another half cardiac dose of tirofiban was administered.Patient was given tirofiban iv drip overnight and was monitored.The ischemic stroke was resolved.The patient was discharged home in stable condition with no symptoms.The ischemic stroke was reported to be a serious adverse event with a definite relationship to the index procedure and possible relationship to the smart coil.
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Please note that the device associated with this complaint was expected to be returned; however, additional information received from a medical affairs associate indicated that the device was disposed of and is no longer available for return.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the neuron max system include, but are not limited to, vessel spasm, thrombosis, dissection, or perforation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-01084.H3 other text: placeholder.
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