Device is combination product.A 3.00 x 32 mm promus premier select stent delivery system was returned for analysis.A visual examination of the stent found no issues on the stent.The mandrel and stent protector were still intact.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured within the maximum crimped stent profile measurement.The tip was visually and microscopically examined, and no signs of damage were noted.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 tactile examination found multiple kinks.A visual examination of the inner and outer lumen and mid-shaft section found the polymer extrusion shaft separated from midshaft 119.2 cm distal to distal strain relief.Damage was noted on the inner lumen of the separated polymer extrusion portion of the device, 7.5cm and 27.3cm distal to the tip.No other issues were identified during the product analysis.
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