Device is a combination product.(b)(4).Device evaluated by mfr: synergy ous mr 2.75 x 32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Proximal stent row 5 was damaged with stent struts lifted and pulled distally.The undamaged crimped stent od(outer diameter) was measured and the result 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.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Reportable based on device analysis completed on 13-oct-2018.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 90% stenosed, 2.75 x 32, eccentric, de novo target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.After pre-dilatation was performed, a 2.75 x 32 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal stent damage.
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