(b)(4).Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
|
Same case as 2134265-2016-03935 & 2134265-2016-03936.It was reported the patient experienced complications post procedure.Three synergy ii drug-eluting stents were implanted; a 3.00x16mm, 2.25x8.0mm and a 2.50x12mm.The patient was discharged the same day and reported feeling great the next morning.However, the afternoon after the procedure her blood pressure went up.She returned to the hospital.A stress test, ekg and 3d echo all revealed normal results.No action was taken.As the patient continued to have issues with high blood pressure, nose bleeds, fatigue, chest pain and shortness of breath, she sought a second opinion.Adjustments were made to her medication.After approximately two weeks, she did feel a little better, but is still having some of the previously noted issues.Another follow up appointment is scheduled.
|