MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	P15P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm, s/n (b)(6), is used on the patient from 2025-06-05 to date.The event occurred on 2025-10-07, which is (124 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart gmbh clinical affairs (ca) on 2025-10-09 to report that a patient being supported with an excor blood pump pu valves; 15 ml in/out; ø 9 mm suffered an ischemic stroke.The patient was noted to have right-sided weakness and a facial droop on 2025-10-07.A ct scan was performed on the event day and revealed a left mca infarct.The ct scan showed that there was near total occlusive stenosis of the left mca, the distal mca branches are opacified and there are no other focal filling defects.This focal segment correlates to the area of hyperdensity on the recent non contrast ct head, therefore, it was most consistent with acute thrombus.According to the update on 2025-10-09, there was some improvement in movement of the right arm and leg, and the patient remained self-ventilating and not too irritable.Multiple small fibrin deposits were noted in the pump, however, the clinic decided not to change the pump before and after the event.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23452590
• Report Number: 3004582654-2025-00060
• Device Sequence Number: 7884884
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)270701
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P15P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 9 KG