Device is a combination product.Device evaluated by mfr.: promus premier ous mr 38 x 2.50mm stent delivery system was returned for analysis.The device was returned with stent protector and pig-tail mandrel attached.Both were removed distally without issue.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (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 tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found outer shaft polymer extrusion tears at two locations; 1cm and 2cm distal to the port bond site, with evidence of stretching/twisting of the outer shaft polymer extrusion at the same locations.A visual and microscopic examination of the bumper tip found distal tip damage.No other issues were identified during the product analysis.
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Reportable based on additional information received on 04sep2019.It was reported the shaft tore.The 60% stenosed, 38mm in length target lesion was in the mildly tortuous, moderately calcified, 2.5mm in diameter right coronary artery.A 38 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, during the procedure the delivery shaft kinked, and cause the shaft to tear.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
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