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 prolapse and occlusion are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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 of the device.
|
Patient id: (b)(6).It was reported that on (b)(6) 2020 three xience sierra stents, sizes 3.25x38, 3.5x38, and 4.0x38 mm, were implanted in the distal right coronary artery (dist rca).When the most distal stent, the 3.25x38, was implanted, occlusion/ plaque shift occurred into the right posterior descending coronary artery.This was treated with balloon angioplasty with a 2.0 mm balloon dilatation catheter advanced through the 3.25 stent struts.The condition resolved.There was no adverse sequela.No additional information was provided.
|