Catalog Number M0033461230SR0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
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Event Date 07/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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This is the ninth of 9 reports.Subject devices remain implanted.
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Event Description
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It was reported that 76 hours post coil embolization of an un-ruptured aneurysm located on the middle cerebral artery with 9 coils (subject devices), the patient suffered one side hemiplegia due to hemorrhage.Use of drugs(not specified) was prescribed in order to treat the adverse event.According to the physician, the adverse event of hemiplegia was related to the procedure and to all of the coils.This report concerns the ninth coil.
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Manufacturer Narrative
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Describe event or problem; executive summary: corrected: the type of hemorrhage was subarachnoid hemorrhage, the drugs used were recombinant activated factorvii and nicardipine, and the adverse event occurred 72 hours post-procedure (not 76 hours).Expiration date: added manufacturing date: added corrected from hemorrhage, cerebral to hemorrhage, subarachnoid.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Hemorrhage and neurological deficits are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
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Event Description
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It was reported that 72 hours post coil embolization of an un-ruptured aneurysm located on the middle cerebral artery with 9 coils (subject devices), the patient suffered one side hemiplegia due to subarachnoid hemorrhage.Use of drugs (recombinant activated factorvii, nicardipine) was prescribed in order to treat the adverse event.According to the physician, the adverse event of hemiplegia was related to the procedure and to all of the coils.This report concerns the ninth coil.
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Search Alerts/Recalls
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