Device evaluated by mfr.: p select ous mr 28 x 3.50mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the proximal end of the stent were lifted and bunched distally.The undamaged 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 no signs of damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found issues.The mid-shaft section was stretched along its length with a kink 185mm distal of the midshaft weld.The shaft polymer extrusion was stretched from the port weld extending 5mm distally.Additionally, the distal inner lumen was stretched and bunched 2mm distal of the bi-component bond extending 5mm distally.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on 17 sep 2020.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed, 3.5mm x 28mm, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the moderately tortuous and mildly calcified ramus intermedius artery.After pre-dilatation was performed, a 28 x 3.50 promus premier select drug-eluting stent was advanced but the physician had difficulties in crossing the lesion.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed a stent damage.
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