Device evaluated by mfr: synergy ii us mr 2.25 x 28mm stent delivery system was returned for analysis.The device was returned without the stent.The balloon was reviewed, and issues were noted.No stent was attached to the balloon and the balloon appeared to be in a deflated state.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.An 0.014 inch guidewire, verified with snap gauge, loaded successfully through the distal end of the tip and exited at the exchange port without issue.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on 13-nov-2020.It was reported that advancing difficulty and shaft damage occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.After the lesion was pre-dilated, a 2.25 x 28 synergy ii drug-eluting stent was selected for treatment but the physician felt unusual resistance during delivery.Upon inspection, the shaft looked strained or stretched.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed stent detachment.
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