It was reported that stent damage occurred.While opening the device during preparation, a 3.00 x 20 synergy drug-eluting stent was noted to be defective with a wire sticking up.The procedure was completed with another of the same device.No known complications were reported.Synergy ii us mr 3.00 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found proximal stent damage, stent struts were pulled and lifted.The undamaged distal section stent.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 several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile 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.
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