On (b)(6) 2020, a 5-2 amplatzer piccolo was selected for implant for a (b)(6) kg premature infant.The device was placed and released, and the delivery cable and catheter were removed from the patient.Further imaging via tte (transthoracic echocardiography) noted that the device was stable and in good position.It was then noted that there was a moderate to severe tricuspid valve regurgitation that was not present pre-procedure and that a there was a flailed tricuspid valve leaflet.It was noted by the physician that this injury to the tv likely occured while the delivery system was in the patient as the ds was crossed into the tricuspid valve and into the pa across the pda to deliver the device.The patient was watched in the cardiac cath lab for an additional hour.The decision was made to transport the patient back to the nicu and monitor the patient closely.
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Additional information for: g4, g7, h2, h6, and h10.The delivery system for the implanted device was not returned, and therefore a physical analysis related to the reported experience could not be completed.The occluder device remained implanted.The serial number was not reported so the analysis of a device from a common or adjacent manufacturing lot could not be completed.
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