The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.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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Patient id: (b)(6).It was reported that this was a coronary intervention in the mid left anterior descending (lad) coronary artery.During the procedure, after post dilatation of the 2.5x18 mm xience sierra stent, a small perforation was noted.Balloon tamponade successfully treated the perforation.Three other xience sierra stents were also implanted during this procedure.There was no additional information provided.
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