Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Embolus (1830)
|
Event Date 06/24/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
This is 2 of 2 reports.The subject device is unavailable to manufacturer.
|
|
Event Description
|
It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the patient had a distal emboli in the internal carotid artery (ica).No adverse event associated with the distal emboli was reported.No further information is available.
|
|
Manufacturer Narrative
|
Additional information received from the site on 28-october-2019 clarified that the adverse event (embolization to new territory) is not related to the trevo and balloon catheter devices.The site also reported that there were multiple clots present at baseline m1, m2, icat (internal carotid artery terminus) bifurcation and the patient died four days later after procedure due to respiratory failure.The site has confirmed that the ent and subsequent event of death were not related to procedure or stryker devices, but related to the pre-existing medical conditions.In addition, the devices did not cause or contribute to the reported event.Nor were they related to a malfunction or deterioration in the characteristics or performance of the devices or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.This is 2 of 2 reports.
|
|
Event Description
|
It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the patient had a distal emboli in the internal carotid artery (ica).No adverse event associated with the distal emboli was reported.No further information is available.Update additional information: additional information received from the site on 28-october-2019 clarified that the adverse event (embolization to new territory) is not related to the trevo and balloon catheter devices.The site also reported that there were multiple clots present at baseline m1, m2, icat (internal carotid artery terminus) bifurcation and the patient died four days later after procedure due to respiratory failure.The site has confirmed that the ent and subsequent event of death were not related to procedure or stryker devices, but related to the pre-existing medical conditions.In addition, the devices did not cause or contribute to the reported event.Nor were they related to a malfunction or deterioration in the characteristics or performance of the devices or labeling issues.
|
|
Search Alerts/Recalls
|