Device is a combination product.Device evaluated by mfr: promus element plus, mr, ous 2.50x28mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the 9th - 12th strut rows distally from the proximal end of the stent were lifted and pulled distally.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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 bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
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