An event that the device "slipped through the defect" was reported.The results of the investigation are inconclusive since the device remains implanted 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that a larger, 32mm, occluder was implanted.
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On (b)(6) 2019, a 28mm amplatzer septal occluder (aso) was selected for implant.After placement, the device slipped through the defect.It was recaptured and withdrawn, and a 32mm aso was implanted successfully.The patient has been discharged.
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