The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
|
The pipeline braid and pushwire were returned for evaluation.In addition, a torque device was observed to be attached to the proximal end of the pushwire.The torque device was removed from the pushwire with no issues.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open, with one end having slight fraying, and the other end having severe fraying.No damages were found on the tip coil, capture coil, and proximal bumper.Based on the analysis findings the clinical observation was not confirmed.The cause for the reported experience could not be deter mined as the returned pipeline braid was observed to be detached from the pushwire.It is possible that the severe vessel tortuosity may have contributed to the reported issue.However, the cause for the damage to the pipeline braid could not be determined.Per the instructions for use (ifu): ¿if the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ all devices are 100% inspected for damage and irregularities during the manufacturing process.
|