(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated dates.Udi#: in the absence of a reported part number, the udi cannot be calculated.(b)(4).The device was not returned for analysis.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.It should be noted the xience v everolimus eluting coronary stent system, instructions for use (ifu) states: patients with a known hypersensitivity or contraindication to everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers may have an allergic reaction to this implant; therefore, the implant is not recommended for such patients.In this case, it is unknown if the ifu deviation contributed to the reported event, as the physician stated the rash may be related to statin use.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported that in approximately (b)(6) 2018, an unk xience stent was implanted in a patient with a known nickel allergy.Four weeks following the stent implantation, the patient developed a rash.It is not known if the rash was related to the nickel allergy or medication that was commenced around the same time.No intervention is planned for the stent at this time and the patient has been referred for a medication review.No additional information was provided.
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