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	03/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The rvad excor blood pump pu valves; 25 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from (b)(6) 2024 to date.The event occurred on 2025-03-08, which is (79 days) after the pump was placed on the patient.The pump remains on the patient.We have reviewed the production records of the excor blood pump, and concluded the pump was produced according to our specification.
Event or Problem Description
The site contacted berlin heart inc (bhi) clinical affairs (ca) on (b)(6) 2025 to report that the patient supported with the excor system in bi-vad configuration experienced left-sided weakness, slurred speech and headache on (b)(6) 2025.A head ct scan was performed and confirmed an ischemic cva on the right side.The patient underwent an ir thrombectomy.According to the site, the excor blood pump performed as intended with complete filling and ejection.Fibrin was noted in the rvad excor blood pump.The clinic decided not to replace the pump.
Additional Manufacturer Narrative
The below information has been inadvertently entered incorrectly in the initial report.A.Serial number in section d4.B.Expiration date in section d4.C.Occupation of the initial reporter in section e3.D.Telephone number in section g1.Therefore, it has been added in the follow-up 1 correction report.

• 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: 21877005
• Report Number: 3004582654-2025-00022
• Device Sequence Number: 7899308
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119(17)270131
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: Other
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 17 KG