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Catalog Number M0036154080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Visual Disturbances (2140)
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Event Date 09/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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This is the 5th of 5 (coils) reports filed associated with this event.Subject devices remain implanted.
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Event Description
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The patient underwent successful stent assisted coil embolization of an aneurysm located in the anterior communicating artery.It was reported that approximately 1 month post-procedure, the patient experienced diplopia (double vision).The event was resolved without any residual effects.The patient was neurologically assessed as having post-procedure mrs of 0.According to the physician, it is possible that the diplopia be related to the stent and to the procedure; it is unknown if the diplopia was related to the implanted coils (subject devices).The patient was neurologically assessed as having a nihss of 0 and mrs of 1 at 2-month follow-up.Approximately 7-month post-procedure, the patient suffered a subdural hematoma due to fall that lasted 17 days.The subdural hematoma was resolved with residual effects.Prolonged hospitalization was required.According to the physician, the subdural hematoma was not related to the procedure, or stent; however, it was unknown if it was related to the implanted coils.The patient was neurologically assessed as having mrs of 4 at 8-month follow-up.
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Manufacturer Narrative
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Expiration date: added.Manufacturing date: added.(b)(4).Outcomes attributed to ae: corrected: since hematoma is not an event associated with the coils, the previously outcome attributed of "hospitalization-initial or prolonged" is no longer applicable to this report.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was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.However, neurological/intracranial sequelae (visual disturbances) is a known risk 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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The patient underwent successful stent assisted coil embolization of an aneurysm located in the anterior communicating artery.It was reported that approximately 1 month post-procedure, the patient experienced diplopia (double vision).The event was resolved without any residual effects.The patient was neurologically assessed as having post-procedure mrs of 0.According to the physician, it is possible that the diplopia be related to the stent and to the procedure; it is unknown if the diplopia was related to the implanted coils (subject devices).The patient was neurologically assessed as having a nihss of 0 and mrs of 1 at 2-month follow-up.Approximately 7-month post-procedure, the patient suffered a subdural hematoma due to fall that lasted 17 days.The subdural hematoma was resolved with residual effects.Prolonged hospitalization was required.According to the physician, the subdural hematoma was not related to the procedure, or stent; however, it was unknown if it was related to the implanted coils.The patient was neurologically assessed as having mrs of 4 at 8-month follow-up.
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Search Alerts/Recalls
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