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

Model Number	P60P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The rvad excor blood pump pu valves; 60 ml in/out; ø 12 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 to date.The lvad excor blood pump used on this patient is an 80 ml in/out ø 12 mm pump which is not distributed in the us market.Therefore, a report for lvad is not required to be submitted.The event occurred on 2025-08-11, which is (10 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and concluded that the pump was produced according to our specification.
Event or Problem Description
Berlin heart gmbh clinical affairs was informed by the clinic on (b)(6) 2025 that the patient on bvad, had suffered an ischemic stroke shortly after re-operation because of retrosternal collection.Very little fibrin spots were seen in both excor blood pumps.The patient was on ecmo support for several days prior to the implant of the berlin heart excor system.The blood pumps performed as intended.

• 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: 22978530
• Report Number: 3004582654-2025-00046
• Device Sequence Number: 13104132
• Product Code: DSQ
• UDI-Device Identifier: 04260090040027
• UDI-Public: (01)04260090040027(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: P60P-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: 08/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG