(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient and there was no reported device malfunction.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of hypersensitivity and rash are listed in xience everolimus eluting coronary stent systems instructions for use 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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.The other implanted xience stent referenced is filed under a separate medwatch report number.
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It was reported that in (b)(6) 2017, the patient underwent a coronary stenting procedure with implantation of two unspecified xience stents.Beginning almost immediately after the stenting procedure, the patient experienced a rash over the trunk area mainly, but also on other parts of the body.Over-the-counter cortisone cream was used, with little effect.The patient had one episode of breathing issues, where it felt like the airway was closing, which was treated with a steroid medication.The episode resolved and the patient has not had other similar episodes.The rash has never gone away.The patient is being seen by a cardiologist and an allergist.No additional information was provided.
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