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	Hemorrhagic Stroke (4417)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on 2025-11-26 to report that on (b)(6) 2025, the patient presented with new onset generalized convulsive seizure, with noted gaze up and to the left.Ct was obtained on (b)(6) 2025 and noted intracranial hemorrhage (ich).After consulting with neurosurgery, surgical evacuation was not recommended.Neurosurgery wants to allow the ich to resorb on its own.The patient was loaded with keppra and continued, all anticoagulation placed on hold (b)(6) 2025 and resumed (b)(6) 2025.Serial cts were performed from (b)(6) 2025 to (b)(6) 2025.The patient is being supported with the excor system in bi-vad configuration.The excor blood pumps maintained full filling and ejection.Deposits were noted in both pumps.
Additional Manufacturer Narrative
The excor blood pumps pu valves; 15 ml in/out; ø 9 mm, lvad, s/n (b)(6) and rvad, s/n (b)(6), are used on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2025, which is (210 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pumps.This pump were produced according to our specifications.The excor rvad blood pump s/n (b)(6) information as follows: the manufacture date for this lot: 2024-05-22.The expiration date for this lot: 2027-04-26.Udi: (b)(4).

• 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: 23849591
• Report Number: 3004582654-2025-00070
• Device Sequence Number: 21321765
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)270701
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/19/2025
• 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: Life Threatening
• Patient Age: 15 MO
• Patient Sex: Male
• Patient Weight: 7 KG