(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy causing the reported failure to advance and subsequent stent dislodgement.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a lesion with heavy tortuosity and heavy calcification in the obtuse marginal coronary artery after the patient had refused to have coronary artery bypass (cabg) surgery.A 2.25 x 15 mm xience alpine stent delivery system (sds) was advanced in the vessel, but met resistance due to the circumflex having an acute angulation and being very tortuous.When the sds was withdrawn from the patient anatomy, it was noted the stent had dislodged in a calcium bed in the vessel.A snare device was used to retrieve the dislodged stent but was unsuccessful.A 3.5 x 15 mm xience alpine stent was deployed crushing the dislodged stent against the calcified artery wall.Therefore, the procedure was aborted as the patient had severe coronary artery disease and had refused cabg.The patient will continue with medical management.No additional information was provided.
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