Catalog Number M0035442030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Visual Disturbances (2140)
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Event Date 02/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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This is the third of 3 reports.Previous reports have been filed for the same patient: mfr report # 3008881809-2018-00044; mfr report # 3008881809-2018-00045; mfr report # 3008881809-2017-00441; mfr report # 3008881809-2017-00440.Subject device remains implanted.
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Event Description
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The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the left superior cerebellar artery.Post procedure the patient was neurologically assessed having a nihss of 0 and a mrs of 1.Six month post-procedure, the patient experienced diplopia that was resolved the next day without residual effect.No treatment was required.According to the physician, the diplopia was possibly related to the procedure and the stent.However it is unknown if the diplopia was related to the 2nd implanted coil (subject device).The patient was neurologically assessed at 2 and 6 month post procedure having a nihss of 0 and a mrs of 1.
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Manufacturer Narrative
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The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, neurological sequelae like diplopia is a known risk associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.
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Event Description
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The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the left superior cerebellar artery.Post procedure the patient was neurologically assessed having a nihss of 0 and a mrs of 1.Six month post-procedure, the patient experienced diplopia that was resolved the next day without residual effect.No treatment was required.According to the physician, the diplopia was possibly related to the procedure and the stent.However it is unknown if the diplopia was related to the 2nd implanted coil (subject device).The patient was neurologically assessed at 2 and 6 month post procedure having a nihss of 0 and a mrs of 1.
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Search Alerts/Recalls
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