Device evaluated by mfr.: synergy ous mr 2.50 x 20mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with struts in proximal region pulled distally.The undamaged stent outer diameter was measured using snap gauge, and the result is within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped, evenly folded, and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube found multiple kinks.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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Reportable based on device analysis completed on 09sep2020.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in the moderately tortuous, and severely calcified right coronary artery.Following pre-dilatation, a 2.50 x 20mm synergy drug-eluting stent was advanced, but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported, and patient status was good.However, returned device analysis revealed stent damage.
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