Reportable based on device analysis completed on 13-mar-2024.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in a mildly tortuous and mildly calcified coronary artery.A 2.50 x 24mm synergy drug-eluting stent was advanced for treatment, but the stent failed to cross the lesion.The procedure was completed with another stent.There were no patient complications reported.However, returned device analysis revealed shaft break.
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Device evaluated by mfr.: synergy ous mr 2.50 x 24mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.There was no sign of damage, stretching or lifting of the stent struts.A visual and tactile examination of the hypotube shaft identified a break at 22cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
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