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 effects of dissection and tissue prolapse/plaque shift are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.
|
Patient id (b)(6).It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending (lad) artery.The 3.5 x 12 mm xience sierra stent was implanted and plaque shift occurred.A second unspecified stent was implanted.Optical coherence tomography was performed and a dissection was noted, related to the plaque shift occurring after deployment of the 3.5 x 12 mm xience sierra stent.A third stent was implanted in the ramus artery via kissing technique, successfully treating the dissection.The event resolved the same day.No additional information was provided.
|