The device was returned for analysis.The reported inflation and deflation issues were not confirmed as the balloon inflated without anomalies and deflated flat within the specified times x3.The wall apposition issue was based on operational context and could not be confirmed.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 identified no other incidents from this lot.The reported patient effect of ventricular fibrillation is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issue as no issue was identified during return device analysis.The reported inflation and wall apposition issues appear to be related to operational context of the procedure.Additionally, the reported patient effect of ventricular fibrillation appears to be related to circumstances of the procedure.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 to treat a de novo lesion located in the proximal left anterior descending coronary artery that was non-calcified, non-tortuous and 90% stenosed.The xience sierra stent system was advanced to the lesion without issues and inflated twice to 12 atmospheres for 10 seconds.It was noted that the wall apposition of the proximal part of the stent was not sufficient, due to how the balloon was inflating, so the delivery system was pulled back about 1 mm and inflated to 14 atmospheres.Attempts to deflate the balloon were made, but it failed to deflate.The patient condition was getting worse and ventricular fibrillation was observed, so the xience sierra stent delivery system was removed slowly.At this point it was noted that the balloon was appearing to deflate.The system was successfully removed and post dilatation was performed for complete wall apposition of the stent.No other treatment was given to the patient.No additional information was provided.
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