Study patient id: (b)(6).It was reported that on (b)(6) 2018, a 2.75x33mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery lesion.An abnormal stress tests occurred following a scheduled follow-up.On (b)(6) 2019, percutaneous catheterization was performed and in-stent restenosis of the 2.75x33mm xience sierra stent was observed.There was no device malfunction.As treatment, another stent was implanted in the mid lad.The event resolved.No additional information was provided regarding this issue.
|
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 effect(s) of stenosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.
|