Device is a combination product. (b)(4).The device was not returned for 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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It was reported that shaft break occurred.The target lesion was located in the saphenous vein graft.A 4.00x16mm synergy ii drug-eluting stent was advanced for treatment.However, while crossing the lesion, it was noted that the shaft broke approximately 20cm from the hub, outside the patient.The device was removed over the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
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