It was reported that on (b)(6) 2021, an 8mm amplatzer septal occluder was selected for implant.During procedure, as the device was deployed inside the patient's body, the device deformed into a cobra shape.The physician attempted to deploy the device twice, however the deformation persisted and the device was removed from the patient.The device was again tested outside of the patient and the deformation persisted.Ultimately, no device was implanted and the patient was sent for surgical closure.The patient was reported to be in stable condition.
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