It was reported that on (b)(6) 2018, the procedure was performed to treat the right coronary artery.Two xience sierra stents (2.75x38mm and 3.0x28mm) were implanted.On (b)(6) 2020, the patient underwent a heart catherization due to chest pain and trouble breathing.It was then confirmed that both stents had collapsed.The stents were opened with angioplasty and two new xience sierra stents (3.5x12mm and 3.5x28mm).There was no adverse patient sequela reported.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of angina and occlusion are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material deformation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5/d6: the estimated implant date was changed from (b)(6) 2018 to (b)(6) 2018.
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It was reported that on (b)(6) 2018, the procedure was performed to treat the right coronary artery.Two xience sierra stents (2.75x38mm and 3.0x28mm) were implanted.On (b)(6) 2020, the patient underwent a heart catherization due to chest pain and trouble breathing.It was then confirmed that both stents had collapsed.The stents were opened with angioplasty and two new xience sierra stents (3.5x12mm and 3.5x28mm).There was no adverse patient sequela reported.No additional information was provided.As the implant date was not confirmed, the last date provided ((b)(6) 2018) will be used as the estimated date.
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