Age at time of event: mid 50's.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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Same case as mdr id: 2134265-2017-03902.It was reported that there was no blood flow in the entire left side of the heart and the patient expired.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending (lad)artery.A 1.25mm rotalink¿ burr and rotawire¿ were selected for use.During the procedure, rotablation was performed in the target lesion.After the third or fourth run, it was noticed that there was no blood flow in the entire left side of the heart.Eventually, the heart stopped.Balloon pump, cardiopulmonary resuscitation, breathing assistance and pharmacological assistance were performed in response to the event.However, the heart was not recovered and the patient expired.
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