Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: promus element mr ous 3.00 x 24mm stent delivery system was returned for analysis.The crimped stent was examined and damage was noted.Proximal strut row 6 was damage with struts lifted and pulled in a distal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was within max crimped stent profile measurement.The bumper tip of the device was examined and no issues were noted.The balloon cones were reviewed and there were no issues to note.The balloon had not been subjected to any significant positive pressure.A visual and tactile examination of the hypotube revealed no issues.An examination of the shaft polymer extrusion identified no issues.The bi-component bond showed no signs of damage or strain.No 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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