It was reported that a few days after implantation of a xience stent, the patient started experiencing symptoms of an allergic reaction, such as a rash.An allergy test was conducted and the result indicated a chrome allergy.This was not known before implantation.Treatment was not reported and the patient continues to experience symptoms.No additional information was provided.
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Date of event: estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.The stent remains in the patient.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the part and lot numbers were not reported.The reported patient effects of rash and hypersensitivity are listed in the xience everolimus eluting coronary stent systems 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
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