Device is combination product.(b)(4).The complaint 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 femoral artery.The 90% stenosed, 24x2.5mm, eccentric, de novo target lesion containing a lesion bend of >45 and <90 degrees was located in the severely tortuous and severely calcified proximal left anterior descending.Predilation was performed using a 1.5x1.5mm non-bsc balloon catheter with residual stenosis of 80%.A 2.50 x 24mm synergy¿ stent was advanced but encountered resistance and failed to cross the lesion.The device was removed and it was noted that the proximal of the stent was deformed.The procedure was not completed as same device is unavailable.No patient complications were reported and the patient's status was stable.
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