There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and thrombosis are listed in the instruction for use everolimus eluting coronary stent systems xience xpedition 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 the design, manufacture, or labeling of the device.The other stent referenced is filed under a separate medwatch report number.
|
Patient id: (b)(6).It was reported that on (b)(6) 2014 two xience xpedition stents (2.5x12mm, 3.5x38mm) were implanted in the mid left anterior descending coronary (lad) artery (mlad).Approximately 3.5 years later, on (b)(6) 2019, the patient experienced chest pain and was re-hospitalized.Lad stent thrombosis was noted.Balloon angioplasty was performed, and the anti-platelet agent was changed, resolving the event.On (b)(6) 2019, angiography confirmed the stents were unobstructed.No additional information regarding this issue was provided.
|