It was reported that on (b)(6) 2021, a 16mm amplatzer septal occluder was selected for implant.During the procedure, the device was navigated through a 9f amplatzer delivery system, however it deformed into a bulbous shape and did not achieve the desired orientation.The device was exchanged for a new 18mm amplatzer septal occluder, which was navigated through the same delivery system and also deformed into a bulbous.The procedure was abandoned and the patient was referred for surgical closure.The patient was reported to be in stable condition.Related manufacturer reference number: (b)(4).
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