Device evaluated by mfr.: promus element plus,mr,ous 2.50x38mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Mid to proximal stent struts lifted.The undamaged stent outer diameter was measured and the result is within maximum crimped stent profile measurement.The balloon was 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 kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on 01-jul-2020.It was reported that advancing difficulties were encountered.The target lesion was located in the severely tortuous and calcified left circumflex artery.A 2.50x38mm promus element plus drug-eluting stent was advanced, but could not reach the lesion even after several attempts.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed stent damage.
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