The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of angina and thrombosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu), as a 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.
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It was reported that the procedure was to treat a lesion in the proximal left anterior descending (plad) and left circumflex (lcx) with 90% stenosis, mild calcification and mild tortuosity.The patient's left ventricular ejection fraction (lvef) was 30%.The lcx was treated with 2.5x48mm xience expedition stent at 16 atmospheres (atms) and post dilated with a 2.5x12mm balloon at 18-26atms.The plad was treated with a non-abbott 2.5x33mm stent at 16 atms and post dilated with 2.75x15mm balloon.Post dilatation was performed per standard procedure.Timi 3 flow was achieved.There was no adverse patient effect and there was no clinically significant delay in the procedure.However, on (b)(6) 2024, the patient came back with chest pain and both vessels where the stents were implanted confirmed blockage on coronary artery angiography (cag).Electrocardiogram (ecg) and troponin test was performed for the chest pain.Occlusion was confirmed to be thrombosis.Patient was referred for coronary artery bypass grafting (cabg) and unknown when it will be performed.No additional information was provided.
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