COMANECI EMBOLIZATION ASSIST DEVICE

Additional Manufacturer Narrative

ACCORDING TO THE COMPLAINT DESCRIPTION, THERE'S NO INDICATION OF ANY DEVICE MALFUNCTION. EMBOLI FORMATION IS A KNOWN COMPLICATION OF WIDE NECK ANEURYSM EMBOLIZATION TREATMENTS WITH ASSIST DEVICES. NO CORRECTIVE ACTIONS ARE REQUIRED.

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED IN THE SUCCESS POST-MARKET SURVEILLANCE STUDY INVOLVING A 65-YEAR-OLD MALE WITH A HISTORY OF HYPERTENSION AND MIGRAINES. HE WAS TREATED WITH THE COMANECI AND ATLAS STENT FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED LEFT UPPER EXTREMITY WEAKNESS AND DYSMETRIA, LEADING TO HOSPITAL ADMISSION. AN MRI REVEALED MULTIPLE ACUTE CEREBROVASCULAR ACCIDENT (CVA) AREAS, PREDOMINANTLY IN THE RIGHT BILATERAL WATERSHED DISTRIBUTION. THE PATIENT CONTINUED DUAL ANTIPLATELET THERAPY AND STATIN TREATMENT. NEUROLOGY SUGGESTED A LOOP RECORDER IMPLANT AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR FURTHER EMBOLIC SOURCE EVALUATION. THE PATIENT UNDERWENT LINQ PLACEMENT AND TEE, WHICH SHOWED NO PATHOLOGY TO EXPLAIN THE CVA. CARDIOLOGY RECOMMENDED FOLLOW-UP IN ONE WEEK. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, WITH FOLLOW-UPS SCHEDULED WITH HIS PRIMARY CARE PHYSICIAN AND CARDIOLOGY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON JUNE 19, 2023.