EXCOR®
Received May 18, 2026 · Event occurred Mar 18, 2026
Report 3004582654-2026-00030 · MDR key 25203202
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
9 MO · Female
- Ischemia Stroke
Narrative
Additional Manufacturer Narrative
THE BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6) WAS PLACED ON THE PATIENT ON (B)(6) 2026 UNTIL THE PUMP WAS EXCHANGED ON (B)(6) 2026. THE EVENT OCCURRED ON (B)(6) 2026, WHICH IS (26 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT, WHO IS BEING SUPPORTED WITH AN EXCOR IKUS DRIVING UNIT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP. THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS.
Description of Event or Problem
THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2026 TO REPORT THAT A PATIENT EXPERIENCED SEIZURE ACTIVITY AND AN ISCHEMIC CEREBROVASCULAR ACCIDENT. THE PATIENT HAD A LEFT PARIETAL STROKE COMPLICATED BY ACUTE SYMPTOMATIC FOCAL SEIZURES ON (B)(6) 2026. A HEAD CT SCAN SHOWED EMBOLIC STROKE ON (B)(6) 2026. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP.
Remedial action
- Patient Monitoring