Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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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Same case as mdr id: 2134265-2016-00016, 2134265-2016-00018, 2134265-2016-00017 and 2134265-2016-00815 it was reported that a vessel dissection occurred.The target lesion was located in a coronary artery.The lesion was predilated with a 2.5x25mm and a 2.0x15mm maverick balloon and then a guide wire was advanced down the vessel.Three promus premier stents, sizes 2.75x16mm, 2.75x12mm, and 2.50x28mm, were advanced in unknown order, but all 3 stents failed to cross the lesion.A 2.5x12mm and a 2.0x20mm non bsc balloon was then able to cross the lesion.At some point during the procedure a dissection occurred.The patient was then sent for coronary artery bypass graft (cabg).No further patient complications were reported.
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