On 05 october 2020, a 8mm amplatzer septal occluder was selected for implant.During deployment, a cobra-shaped deformation was noted.The device was withdrawn, and recovered shape outside the patient on the table.A new 35mm amplatzer pfo occluder was successfully implanted.The patient was reported to be in stable condition.
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Additional information: d10, h3, h6.The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
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