(b)(4).The device was not returned for evaluation and there was no reported device malfunction.A review of the lot history record revealed no nonconformities associated with this lot.It should be noted that the reported patient effect of allergic reaction is listed in the absolute pro instruction for use (ifu) as a known patient effect.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment with medications and hospitalization are due to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that on (b)(6) 2018, two absolute pro stents were implanted without reported issue in the patient's groin area.Since implantation, the patient has been itching and has a swollen face.The patient has not experienced any difficulty breathing.The patient was hospitalized twice for the allergic reaction and medication benadryl and steroids were provided.No additional information was provided regarding this issue.
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