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 stent damage occurred.Vascular access was obtained via the right side.The 90% stenosed, 30mm in length, eccentric, de novo target lesion was located in the non-tortuous, severely calcified and 3mm in diameter right coronary artery.Following pre-dilatation with 2.5/20 and 3.0/20 emerge balloons, residual stenosis was 41%.A 3.00x32mm synergy¿ stent was advanced but failed to cross the lesion.The device was removed and it was noted that the proximal part of the stent was deformed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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