Related manufacturer reference number: 2135147-2021-00176.On an unknown date, a 20mm amplatzer septal occluder was selected for implant using a 9f amplatzer torqvue delivery system.During procedure, as the loader was being connected to the delivery sheath, an air embolism was observed over the delivery sheath and required aspiration from the right coronary artery.The patient was transferred to the intensive care unit (icu) post-procedure.In the icu, an intracerebral event/stroke was observed and the patient was monitored.The patient was reported have been discharged in stable condition to receive rehabilitation for the stroke.
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Additional information sections: h6, h10.An event of air embolism and stroke was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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