The physician was attempting to deploy a 3.
0 mm diameter x 38mm length resolute integrity rapid exchange (rx) drug eluting stent to treat a lesion located in the lcx that exhibited moderate tortuosity, little calcification and 80% stenosis.
It was reported that prior to use, the device was inspected and prepped with no issues noted.
It was also reported that the lesion was pre-dilated twice with less than 50% stenosis remaining.
Resistance was felt while advancing the resolute integrity stent inside the vessel towards the lesion and upon removal from the pt, the stent was reported to be damaged.
No pt injury occurred and no clinical sequelae were reported.
Evaluation: results - (patient vessel/lesion morphology; tortuosity of the vessel has prevented the device from advancing to the lesion), (stent deformation and failure to deliver device).
Conclusion - (patient vessel/lesion morphology; tortuosity of the vessel has prevented the device from advancing to the lesion).
Evaluation summary: the seventeenth and eighteenth proximal stent segments were raised, damaged and deformed.
The twenty third and twenty fourth proximal stent segments were raised and deformed.
A number of other segments were slightly raised and deformed.
The stent was positioned on the balloon between the marker bands as per specs.
The inflation lumen was kinked.
Please note that this device (b)(4) is distributed outside the united states; however, it is similar to the united states distributed product (b)(4).