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

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	05/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lvad excor blood pump pu valves; 50 ml in/out; ø 12 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 until it was removed from the patient on (b)(6) 2025.The event occurred on 2025-05-08, which is (63 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.
Event or Problem Description
Berlin heart gmbh clinical affairs was informed by the clinic on 2025-07-03 that a patient was presented with a headache, and a ct scan was performed.A small hemorrhagic stroke was identified on (b)(6) 2025.Anticoagulation was stopped but over the next days the bleeding increased, and the patient was declared brain dead and died on (b)(6) 2025 due to massive cerebral hemorrhage.The patient was being supported with an excor blood pump pu valves; 50 ml in/out; ø 12 mm.No deposits in the excor blood pump were recorded.

• 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 22569673
• Report Number: 3004582654-2025-00041
• Device Sequence Number: 18453485
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: (01)04260090040010(17)261130
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: P50P-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: 07/03/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: Death
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 74 KG