Device is a combination product.A 3.50 x 24mm synergy stent delivery system was returned for analysis.Examination of the crimped stent identified distal stent damage.Stent struts at the proximal end of the stent were flared outwards and damaged.Damage was noted to the most distal stent strut row with struts lifted and pulled back distally.The undamaged crimped stent outer diameter was measured using snap gauge and was within max 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.There was no evidence of a balloon profile issue.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.Examination of the tip found damage to the tip.Device was loaded onto and tracked over a 0.014 inch guidewire without issue.An attempt was made to insert the device into a 5fr guide catheter however the device could not be inserted.The distal end of the stent met resistance which appeared to be due to the stent damage.An attempt was made to insert the device into a 6fr guide catheter, the device was inserted into and advanced through and withdrawn from the 6 fr guide catheter without issue.No other issues were identified during the product analysis.
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Reportable based on analysis completed on 30oct2019.It was reported that the balloon was already inflated prior to use.A percutaneous coronary intervention was being performed.During prep, the 3.50 x 24mm synergy ii drug-eluding stent balloon was noted to be expanded at its proximal and distal ends and could not be introduced.The procedure was successfully completed without issue or patient injury.However, returned device analysis revealed stent damage.
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