It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (lad).A 2.75 x 23 mm xience sierra stent was implanted; however, it was noted that the stent was under-expanded and additional post dilatation was performed.After post dilatation, the stent was fully expanded.Additionally, one day post-procedure, troponin was elevated.No additional information was provided.
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Internal file number: (b)(4).The device was not returned for analysis.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.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulty to deploy (wall apposition) could not be determined.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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