(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.The reported patient effect of hypersensitivity is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.Based on the case information, 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 respects to the design, manufacture, or labeling of the device.
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It was reported that on (b)(6) 2013, the xience xpedition stent was implanted in the right coronary artery.One day after the procedure, the patient began experiencing vertigo.No treatment has been performed.There is no issue with the stent, and the patient believes that the dapt (plavix, aspirin) medication may be the cause for the vertigo.Updated information received from the patient stating that the vertigo and other worsening symptoms were due to an allergic reaction to the stent implant.She has been seen by an allergist, who has been running tests and confirmed her allergy to metal.It is unknown if any treatment has been performed.No additional information was provided.
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