Same case as mfr #: 2134265-2014-07856, 2134265-2014-07858, 2134265-2014-07859, 2134265-2014-07860, 2134265-2014-07861, 2134265-2014-07970.It was reported that a dissection, thrombosis and death occurred.The 90% stenosed lesion was located in the calcified and moderately tortuous coronary artery.A 7fr wiseguide catheter was positioned in the main coronary artery.A 1.25mm rotalink and a 330cm rotawire were selected to treat the lesion.While performing platform testing outside of the patient, the burr fractured the guide wire.The devices were exchanged for another 1.25 rotalink burr and another 330cm rotawire.The rotawire was positioned in the artery.While inserting the tip of the burr inside the wiseguide catheter, it was noted that the physician may not have had a proper hold on the catheter and ¿intubated¿ the artery resulting in a dissection.The catheter was removed and ¿clottings¿ were noted on site.Rotablation was not performed.The dissection was treated with two promus element plus stents, a 3.50x20mm and a 2.50x38mm, in the anterior descending and the circumflex arteries.However, thrombosis occluded the artery and the patient died in the icu approximately 10-15 minutes after the procedure.The physician indicated that the devices performed as expected and that the dissection occurred due to the condition of the patient.
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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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