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

Model Number	P25P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	10/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 25 ml in/out; ø 9 mm, s/n (b)(6), was used on the patient from (b)(6) 2025 until the patient was transplanted on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (47 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump s/n (b)(6) and concluded this pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on (b)(6) 2025 to report that the patient being supported with an excor blood pump pu valves; 25 ml in/out; ø 9 mm suffered an ischemic stroke.The patient was noted to have seizure activity, decreased muscular tone, new lower upper extremity (lue) weakness and hyperreflexia.A ct scan was performed on the event day and revealed a chronic mca infarct in cortical, parietal and frontal territories.Fibrin strands were noted at the outflow valve and the in- and outflow connectors of the blood pump.

• 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: 23469048
• Report Number: 3004582654-2025-00063
• Device Sequence Number: 8890512
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)280111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: P25P-001X01
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 15 KG