(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: stent: xience v (3.5x15, 2.75x12, 2.5x15, 2.75x28, 2.5x12 (x2), 2.5x28), aspirin, ticagrelor.(b)(4).There was no reported device malfunction and the product was not returned.The investigation was unable to determine a definitive cause for the patient effect.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 myocardial infarction and restenosis, as listed in the xience v everolimus eluting coronary stent system instructions for use, are known patient effects that may be associated with the use of the device.Although 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 manufacturing, design or labeling.The other 3.5x15mm xience v referenced is filed under a separate medwatch mfr number.
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It was reported that five xience v stents (two 3.5x15, 2.75x12, 2.75x28, 2.5x15) were implanted in three coronary arteries (left main, mid left anterior descending (lad), first diagonal) on (b)(6) 2012.A staged procedure in the right coronary artery and posterior descending artery was performed on (b)(6) 2012 with three xience v stents (two 2.5x12s and one 2.5x28) implanted.The patient had a myocardial infarction on (b)(6) 2016.Intravenous furosemide was administered in the hospital.Percutaneous coronary intervention was performed on (b)(6) 2016 in the left main, proximal lad and proximal left circumflex coronary arteries.There was 90% in-stent restenosis in the proximal left circumflex and 50% in-stent restenosis in the left main to the lad.The condition resolved.No additional information was provided.
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