|
Catalog Number M0031681890 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Headache (1880)
|
Event Date 04/01/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
This is tenth of 10 reports filed associated with this event.
|
|
Event Description
|
The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils and access devices (subject device).No further information is available.
|
|
Manufacturer Narrative
|
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, headache is a known risk associated with endovascular procedures and noted as in the clinical experience summary for neurovascular microcatheters.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
|
|
Event Description
|
The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Medication was administered to treat the headache (2mg dexamethasone and 1 mg morphine and 650 mg acetaminophen).Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils (subject devices) and access devices.No further information is available.
|
|
Search Alerts/Recalls
|
|
|