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Catalog Number UNK_NEU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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This is 2 of 4 reports.The subject device is unavailable to manufacturer.
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Event Description
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It was reported that beyond 48 hours after the study procedure, the patient developed a stroke from the right middle cerebral artery (m1) region which resulting in inpatient hospitalization.Medical management was administered, and the event was resolved in the next day.The study facility reported that the relationship of the stroke to the subject device distal access catheter, the retrieve, the balloon guide catheter, the aspiration pump and to the index procedure.No further information is available.
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Manufacturer Narrative
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Section b5 - executive summary: update: based on additional information received from the site on (b)(6)2020 clarified that there was no relationship between the adverse event patient¿s stroke with the subject device retriever.Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore.Section b1: adverse event/product problem: corrected: no adverse event or product problem section b2: outcomes attributed to ae: corrected: no other serious (important medical events).Section h1: type of reportable event: corrected: removed serious injury - no serious injury the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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Event Description
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It was reported that beyond (b)(4) hours after the study procedure, the patient developed a stroke from the right middle cerebral artery (m1) region which resulting in inpatient hospitalization.Medical management was administered, and the event was resolved in the next day.The study facility reported that the relationship of the stroke to the subject device distal access catheter, the retrieve, the balloon guide catheter, the aspiration pump and to the index procedure.No further information is available.Update additional information: based on additional information received from the site on 1-may-2020 clarified that there was no relationship between the adverse event patient¿s stroke with the subject device distal access catheter.Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore.
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Search Alerts/Recalls
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