EXCOR®

Additional Manufacturer Narrative

THE BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6) WAS USED ON THE PATIENT FROM (B)(6) 2026 UNTIL THE PATIENT WAS TRANSITIONED TO ECMO ON (B)(6) 2026. THE EVENT OCCURRED ON (B)(6) 2026, WHICH IS (12 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT, WHO IS BEING SUPPORTED WITH AN EXCOR ACTIVE 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 (BH) CLINICAL AFFAIRS (CA) ON 2026-04-23 TO REPORT THAT A PATIENT WHO EXPERIENCED A CEREBRAL HEMORRHAGE, HAD SECOND BLEEDING EVENT WITH ISCHEMIC CHANGES ON (B)(6) 2026. THE PATIENT UNDERWENT SURGERY AND WAS SWITCHED OVER TO AN ECMO SYSTEM TO BE SUPPORTED WITHOUT ANTICOAGULATION. THE CLINIC PROVIDED BH CA THE UPDATED INFORMATION THAT THIS WAS A HEMORRHAGIC EVENT WITH HYDROCEPHALUS, REQUIRING VENTRICULAR DRAINAGE. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION. DEPOSITS WERE NOTED IN THE CONNECTING SET.