Conclusion: the device was not returned.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Continued total occlusion is a known potential complication associated with the use of the revive se.The root cause of the events could not be conclusively determined; however, procedural/patient factors may have contributed to the event.As per the ifu: ¿contraindications for this device include extreme vessel tortuosity or other conditions preventing the access of the device¿.The ifu also warns that ¿if the revive se device is unable to reach or cross the occlusion, the procedure should be terminated.¿ since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.Hemorrhage and stroke are also known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.The revive se is not distributed in the u.S.; however, is similar to the revive pv that is distributed in the u.S.This is an initial/final mdr report.
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As reported via the revive se pms (b)(6) ((b)(6)), who presented with cardiogenic cerebral infarction, expired due to intracranial hemorrhage at the occluded blood vessel site within 24 hours of thrombectomy with a revive se ((b)(4)) which only partially removed the clot.The patient had presented with internal carotid artery/right middle cerebral artery (m1) occlusion.Before the procedure on (b)(6) 2017, aspects-ct was 8 points, aspectsd-dwi was 8 points, nihss was 11 points.There was moderate vessel tortuosity at the occlusion site.The vascular diameter at the proximal occlusion site was 2.5mm.Length of thrombus was unknown.It was reported that t-pa was not applicable.The revive se was deployed once at the lesion, with a result of tici 2a.Also, another device was deployed once with tici of 3.The symptomatic intracranial hemorrhage was confirmed at the occluded blood vessel region seven hours after the procedure.Cerebral edema, disturbance of consciousness and respiratory failure was observed as symptoms caused by the symptomatic intracranial bleeding within 24 hours.The symptoms worsened and the patient expired on (b)(6) 2017.
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