Device is a combination product.(b)(4).Device evaluated by mfr: synergy ous mr 2.50 x 16mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.The most proximal stent strut row was damaged and lifted from the stent profile.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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