Device evaluated by mfr.: synergy ous mr 2.50 x 24 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent struts from the mid to proximal end of the stent were lifted and pulled in all directions.The undamaged crimped stent outer diameter measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent struts met resistance of a calcified lesion.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found no issue with the extrusion shaft.No other issues were identified during the product analysis.
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