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

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 50 ml in/out; ø 12 mm; lvad sn (b)(6) was in use on the patient from (b)(6)2024 until the pump was exchanged on (b)(6)2024 (31 days).We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.
Event or Problem Description
Berlin heart gmbh clinical affairs was informed by the clinic that during the night of (b)(6)2024 the patient supported with an excor pediatric system in bi-vad configuration, showed very short speech weakness.A head ct scan was performed and showed hemorrhagic stroke.The anticoagulation has been stopped upon the recommendation of a neuro consultant at clinic.Moreover, on (b)(6)2024, thrombus was seen in the outflow valve area of the lvad, and a decision was made to change the lvad pump.However, the thrombus was no longer present at the time the surgeon arrived.Therefore, the pump was not changed.During the evening of (b)(6)2024., a small fibrin/thrombus layer was observed in the lvad, and it was decided to monitor the pump.The pump was later changed on (b)(6)2024 after hemorrhagic stroke and the patient remained asymptomatic until the morning.The excor blood pump functioned as intended with full fill and ejection.The patient showed no signs of infection.

• 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: 21057090
• Report Number: 3004582654-2025-00002
• Device Sequence Number: 12779503
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: (01)04260090040010(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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 Expiration Date: 07/31/2026
• Device Model Number: P50P-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: 12/07/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 35 KG