On (b)(6) 2020, a 4-4 amplatzer piccolo was selected for implant on a (b)(6) kg patient.The patient has the following pda dimension; minimal diameter: 2.5mm, ampulla: 4mm, length:6mm and the device was placed intraductal.The device was released and looked in a stable position.On chest x-ray, it was observed that the device had embolized to the pulmonary artery.The 4-4 piccolo was snared and removed from the patient.A 5-2 piccolo was implanted instead.The chest x-ray was completed in the nicu and the device was seen to be in a stable position.The patient is currently stable and recovering in the nicu.
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Additional information for: g4, g7, h2, h6, and h10.An event of device embolization of the 4-4mm piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, arten600042307 version b, the correct size piccolo occluder for the measurements provided was 4-2mm piccolo, smaller than the embolized device.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 event could not be conclusively determined.A capa was initiated for further investigation on the device embolization per internal procedures.
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