Estimated date of event and implant.There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The reported patient effect of hypersensitivity is listed in the electronic instructions for use everolimus eluting coronary stent systems xience proa ce (ifu) as a known patient effect of coronary stenting procedures.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The xience proa device is currently not commercially available; however, it is similar to a device sold in the u.S.
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It was reported that in (b)(6) 2020 the xience pro a stent was implanted in the mid left circumflex coronary artery.One to three days after the stent procedure, the patient had trugiformis eczema.The dermatologist reported that the eczema may be related to the xience pro a stent as the patient has an intolerance to cobalt chromium.The patient was admitted to the hospital and was treated with medication.The patient has been discharged from the hospital, but the condition is ongoing.No additional information was provided.
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