The reported information does not suggest a device malfunction, and the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure to treat an occlusion in the m2/m3 segment of the middle cerebral artery (mca).The imperative care tracstar 088 ldp was used as the access catheter to support delivery of a penumbra 3max reperfusion catheter and a guidewire.All three devices were advanced to the cavernous segment of the internal carotid artery (ica), then the physician continued to advance the 3max and guidewire to the site of the occlusion.Aspiration was successfully performed using the 3max and it was removed from the patient.Subsequently, the physician decided to treat carotid atherosclerosis noted earlier in the procedure and pulled the tracstar back to perform a contrast imaging run.On the imaging run, the physician noted a carotid cavernous fistula (ccf) that wasn't present at the start of the procedure.As the tracstar, 3max, and guidewire were all advanced through the cavernous ica it is possible that one of these devices caused the ccf.The physician continued the procedure to treat the carotid atherosclerosis and decided that the ccf did not require immediate treatment as it was slow filling and asymptomatic.While the patient was asymptomatic following the procedure, a 30 day follow up cta was prescribed to monitor the ccf.
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