On (b)(6) 2020, a 18mm amplatzer septal occluder(aso) was selected for implant in the patient after measuring the size with a sizing balloon.During the procedure the aso was attempted to be implanted, but the physician decided that the aso was under-sized.Thrombus had formed in the patient and adhered to the delivery cable during the procedure.The physician was concerned about the thrombus adhering on the delivery cable and decided to remove the 18mm aso and the 9f 45/80 amplatzer torqvue delivery system from the patient.The devices were replaced with a 20mm amplatzer septal occluder(aso) and a 10f 45/80 amplatzer torqvue delivery system to continue the procedure.The 20mm aso was successfully implanted with no adverse consequences to the patient.It took time in the attempt to deploy the first 18mm aso in the patient's defect, so the delivery cable and the sheath were in the patient longer than usual procedures.However, the delay was not significant and the patient remained hemodynamically stable during the procedure.
|