Device evaluated by mfr.: promus element plus,mr,ous 2.25x28mm stent delivery system was returned for analysis.A visual examination of the stent found proximal stent damage.The undamaged stent outer diameter was measured and the result was within max 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 no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues.0.0140" recommended guidewire inserted through distal tip and exited at exchange port without issue.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on 21-sep-2020.It was reported that advancing difficulties were encountered.The target lesion was located in the left anterior descending artery.A 2.25x28mm promus element plus drug eluting stent was advanced for treatment.However, the device could not be advanced to the lesion part.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed stent damage.
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