Catalog Number M0036128300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Stroke/CVA (1770)
|
Event Date 02/14/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
This is 2 of 2 reports.The subject device was implanted.
|
|
Event Description
|
It was reported that post 'anterior communicating artery complex (acom) procedure, the infarct area was seen on the imaging (computed tomography) as no treatment was provided to the patient and the event was resolved without sequelae to the patient.
|
|
Event Description
|
It was reported that post 'anterior communicating artery complex (acom) procedure, the infarct area was seen on the imaging (computed tomography) as no treatment was provided to the patient and the event was resolved without sequelae to the patient.
|
|
Manufacturer Narrative
|
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The event description indicates the adverse event was possibly related to the target coils.No device malfunction was reported.An assignable cause of anticipated procedural complication will be assigned to this complaint investigation.A product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
|
|
Search Alerts/Recalls
|