(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
On the initial attempt, the 16 mm amplatzer septal occluder (aso) did not deploy as intended and was unable to be positioned as desired.During the second attempt, the device was deployed and released from the delivery cable but embolized to the right atrium after deployment.The aso was surgically removed.A 14mm aso was successfully implanted.
|