No product was returned to the manufacturer for evaluation.Therefore, a definitive cause of the reported event is unable to be determined.A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Additionally, this was the first reported adverse event of this nature associated with this lot.Monitoring will continue to be performed for this lot.Complaints will continue to be monitored for any trends.
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It was reported that a tcar procedure performed in (b)(6) 2019 was uneventful with regards to access.The dual antiplatelet therapy (dapt) protocol was followed and all tcar steps including tcar timeout were performed.Pre-dilation with a 5mmx20mm balloon was performed and a 9mmx30mm stent was placed without incidence.The patient woke up fine and was able to respond to basic commands before leaving the room.However, forty-eight hours after completion of the procedure, the patient reported numbness and weakness in the left hand.The hospital conducted a follow up ct scan and radiology observed two small infarctions.The ct scan showed a small dark crescent mid stent on the axial cuts, presumably a clot.The patient was placed on a heparin drip and was improving or improved at the time of discharge.No additional details were provided.
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