Age at time of event: 18 years or older.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 and 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 95% stenosed, 24mm in length, eccentric, de novo target lesion contained a greater than 45 and less than 90 degree bend and was located in the mildly tortuous, mildly calcified, and 3-4mm in diameter right coronary artery (rca).A 4.00 x 24 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 patient's status was stable.
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