Catalog Number M0035452540 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Transient Ischemic Attack (2109)
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Event Date 09/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is 1 of 8 (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 basilar apex artery.It was reported that approximately 24 hours post procedure the patient experienced a transient ischemic attack (tia).Post procedure national institute of health stroke scale (nihhs) was 4 and modified ranking scale (mrs) was 4.The hospitalization was prolonged due to the tia and it resolved without residual effect.The physician believe that the tia was probably related to the stent device, the procedure, and possibly related to the implanted coils.The patient was assessed having a mrs of 1 at 2 months and a mrs of 0 at 6 months post the index procedure.
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Manufacturer Narrative
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Expiration date: updated.Lot#: added.Manufacturing date: updated.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, tia (transient ischemic attack) 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 basilar apex artery.It was reported that approximately 24 hours post procedure the patient experienced a transient ischemic attack (tia).Post procedure national institute of health stroke scale (nihhs) was 4 and modified ranking scale (mrs) was 4.The hospitalization was prolonged due to the tia and it resolved without residual effect.The physician believe that the tia was probably related to the stent device, the procedure, and possibly related to the implanted coils.The patient was assessed having a mrs of 1 at 2 months and a mrs of 0 at 6 months post the index procedure.
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Search Alerts/Recalls
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