Same case as mdr id 2134265-2014-00476.It was reported that in-stent restenosis occurred.In (b)(6) 2013, two 8.0x29 carotid wallstents were implanted to treat stenosis in the carotid artery.In (b)(6) 2014, the patient returned with restenosis in the same area.During the procedure, the physician saw a "hole" in one of the wallstents and suspected a "corrosion or rupture of a strut".The physician treated the restenosis with another wallstent.It was found out that the patient flexed his head two times, the last time being a couple of days before the event.It was noted that the patient "overflexed" his head two times, with the last time being a couple of days before the event.No further patient complications were reported and the patient's status was stable.
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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).
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