Device evaluated by mfr.: synergy ous mr 3.00 x 24 mm stent delivery system was returned for analysis.A visual examination of the crimped stent found that the stent had detached from the sds and was not returned for analysis.As part of the analysis, a review of the manufacturing data for the stent profile was performed.The maximum crimped stent profile measurement is within the specification.The balloon cones were reviewed, and no issues were noted.The balloon wings were relaxed appearing as if the balloon was subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer extrusion and mid-shaft section, and visual examination of the inner extrusion found no issue with the extrusion shaft.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on 25sep2020.It was reported that crossing difficulties were encountered.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 3.00 x 24 synergy drug-eluting stent was advanced, but failed to cross lesion.The device was removed from the patient's body and completed the procedure with another of the same device.There were no complications reported and the patient is stable.However, returned device analysis revealed stent detached/separated.
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