A patient with a multi-fenestrated septum required a 30mm cribriform (9-asd-mf-030).Upon delivery to the defect, the device appeared to shape itself into a dumbbell configuration, and did not lie flat against the interatrial septum.The fear in release was that the extra volume would interfere with other cardiac anatomy or cause adverse events.The device was thought to be too large so it was retrieved, and removed from the patient.Upon inspection, the device did not return to its correct shape so a 25mm cribriform (9-asd-mf-025) was used, and implanted into the patient.Patient is stable.
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The reported event of a "dumbbell", bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met 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 defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.
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