Device is a combination product.Device evaluated by mfr.: promus elite ous mr 20 x 2.75 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage, with struts on the distal end lifted and pulled distally.The undamaged crimped 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 signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
|