|
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Transient Ischemic Attack (2109); Weakness (2145); Lethargy (2560)
|
Event Date 10/19/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The device was implanted in the patient and is no longer available for evaluation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.Potential adverse events with the penumbra smart coil (smart coil) system include cerebral ischemic events and neurological deficits, and are included in the labeling.Therefore, it was determined that the reported transient ischemic attack (tia) was a potential complication related to the use of the smart coil system.The device was implanted in the patient.
|
|
Event Description
|
On (b)(6) 2017 the patient underwent a coil embolization procedure using penumbra smart coils.During the procedure, a smart coil migrated from the aneurysm and into the anterior cerebral artery (aca).The patient was given aspirin.On (b)(6) 2017, the patient presented with increased lethargy, inattentiveness and right leg weakness.The head computed tomography (ct) showed a left inferior paramedian frontal lobe infarct.The patient's symptoms were resolved on the same day, (b)(6) 2017.The transient ischemic attack (tia) was adjudicated to be a non-serious adverse event with a definite relationship to the smart coil system.
|
|
Manufacturer Narrative
|
Reportable event: serious injury.
|
|
Event Description
|
On (b)(6) 2017 the patient underwent a coil embolization procedure using penumbra smart coils.During the procedure, a smart coil migrated from the aneurysm and into the anterior cerebral artery (aca).The patient was given aspirin.On (b)(6) 2017, the patient presented with increased lethargy, inattentiveness and right leg weakness.The head computed tomography (ct) showed a left inferior paramedian frontal lobe infarct.The patient's symptoms were resolved on the same day, (b)(6) 2017.The transient ischemic attack (tia) was adjudicated to be a non-serious adverse event with a definite relationship to the smart coil system.Additional information reported in the smart edc system on 13-june-2018: mri imaging indicated corpus callosal infarct, likely subacute infarct involving the left gangliocapsular region.Flair hyperintensity is noted within the left frontal lobe extending into the left basal ganglia region which may reflect prior ischemic change and/or edema.
|
|
Search Alerts/Recalls
|
|
|