(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 effects of angina and stenosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll) everolimus eluting coronary stent system instructions for use (ifu) 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that on (b)(6) 2013, the patient underwent a coronary procedure with implantation of a 3.5 x 23 mm xience prime stent in the left main coronary artery.In (b)(6) 2016, the patient was re-hospitalized with unstable angina.A revascularization procedure was performed at an unspecified location and the event resolved in (b)(6) 2016.No additional information was provided.
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