The device was not returned for analysis.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 of aneurysm is listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use (iifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.
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It was reported that the procedure was to treat a 90% stenosed de novo lesion in the left anterior descending (lad) with mild calcification and moderate tortuosity.On (b)(6), 2022, the 3.00x15mm xience prime stent was implanted.On (b)(6), 2023 during a post procedure follow-up an aneurysm was noted at the stent implant.The patient was hospitalized for further treatment.In the physician's opinion the xience prime stent caused the aneurysm.No additional information was provided.
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