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

Model Number	P10P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6) was used on the patient from (b)(6) 2025 until the pump was replaced on (b)(6) 2026.The event occurred on 2026-03-19, which is (129 days) after the pump was placed on the patient, who is being supported with an excor ikus driving unit.We have reviewed the production records of the excor blood pump.This pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on 2026-03-24 to report that a patient with excor blood pump pu valves; 10 ml in/out; ø 6 mm, experienced a neurological event on (b)(6) 2026.The patient presented with weakness, gastrointestinal symptoms, mostly vomiting, that worsened on (b)(6) 2026.Multiple fibrins were noted in the cannula: cluster fibrin at the outflow, scattered fibrin in the silicone part of the outflow cannula, one flapping fibrin in the lv outflow cannula.There were 2 flapping fibrins to the lv outflow cannula and small additional fibrin strand to anterior aspect of the outflow cannula.Head and neck ct scans performed on (b)(6) 2026 showed mycotic ruptured aneurysm, acute thrombus/hyperdense mca.There was no evidence of large vessel occlusion.After neurological consultation, a neuro angiogram as well as an intracranial aneurysm coiling were subsequently performed.The berlin excor blood pump functioned as intended maintaining full filling and ejection.Multiple deposits were noted in the outflow cannula before and after the event.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 24982976
• Report Number: 3004582654-2026-00025
• Device Sequence Number: 21445430
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)271023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/24/2026

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: P10P-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: 03/24/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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: Life Threatening
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 6 KG