COMANECI 17
Received Mar 27, 2023 · Event occurred Dec 14, 2022
Report 3015531723-2023-00006 · MDR key 16618081
Device
Generic name
Comaneci 17
Manufacturer
Rapid Medical Ltd.Model number
ANPP7199Catalog number
ANPP7199
Lot number
220917CS01
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR · Female
- Aneurysm
- Aneurysm
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THROMBUS FORMATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF COIL EMBOLIZATION ASSIST DEVICES, INCLUDING COMANECI DEVICE. THE IFU IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
Description of Event or Problem
THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. A 58-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, HYPONATREMIA, TOBACCO ABUSE DISORDER, AND PREVIOUS ANEURYSMS, WAS TREATED WITH THE COMANECI 17 (L-MCA ANEURYSM). SUBJECT TOLERATED THE PROCEDURE BUT SHORTLY AFTER DEVELOPED RIGHT SIDED WEAKNESS, NEGLECT, INCOMPREHENSIBLE SPEECH (NIHSS 20). CT HEAD W/O CONTRAST NEGATIVE FOR ACUTE INTRACRANIAL ABNORMALITIES. SUBJECT WAS TAKEN BACK TO THE IR SUITE FOR A CEREBRAL ANGIOGRAM WHICH DEMONSTRATED DISTAL OCCLUSIONS, AGRRASTAT WAS INJECTED. S/P INJECTION PATIENT ABLE TO MOVE RIGHT SIDE, ALERT AND ORIENTED TO PERSON, ABLE TO SPEAK AND ANSWER QUESTIONS WITH SOME APHASIA AND DYSARTHRIA NOTED, SHE HAS FACIAL DROOP (NIHSS 8).