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Catalog Number 90182 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Infarction, Cerebral (1771); Embolus (1830)
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Event Date 02/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is 2nd of 2 reports filed for this event.The subject device is not available.
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Event Description
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The patient underwent a thrombectomy procedure achieving a tici score of 2b, and at 24 hours post procedure, a nihss of 21.Embolization to new territory (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent occurred.No adverse event was reported associated with the ent.The patient was reported to have died due to respiratory failure approximately six days post the index procedure.No further information is available.
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Manufacturer Narrative
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The device history record (dhr) review cannot be performed because the lot number was not provided.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available; the cause of the reported issue cannot be determined.However, embolus and stroke are known risks associated with endovascular procedures and are noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
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Event Description
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The patient underwent a thrombectomy procedure achieving a tici score of 2b, and at 24 hours post procedure, a nihss of 21.Embolization to new territory (ent) was not observed by the study facility post procedure; however, further review performed by independent lab facility indicated that ent occurred.Mri performed on the same day showed acute infarcts in the left middle cerebral vascular territory and left anterior cerebral artery distribution.The patient did not experience symptoms resulting from the acute infarcts compare to the initial stroke symptoms.No medical treatment was administered due to the lack of change in clinical presentation.No adverse event was reported associated with the ent.However, the patient was reported to have died due to respiratory failure, and the presenting condition pre-procedure approximately six days post the index procedure.No further information is available.
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Search Alerts/Recalls
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