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	Transient Ischemic Attack (2109)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2025-06-02, berlin heart clinical affairs was informed that the patient seizure on (b)(6) 2025.Ct was performed, and small clots in the brain were identified.At the time of the event, small fibrin were noted in the inflow and outflow area of the excor blood pump; 15 ml in/out; ø 9 mm.The patient was escalated to a continuous flow device on (b)(6) 2025 and was successfully weaned and explanted for recovery on (b)(6) 2025.
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from (b)(6) 2025 until the escalation to a continuous flow device (temporary vad) the event occurred on 2025-06-01, which is (51 days) after the pump was placed on the patient.According to the site, the patient was successfully weaned and explanted for recovery on (b)(6) 2025.We have reviewed the production records of the excor blood pump and concluded that the pump was produced according to our specification.

• 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: 22375503
• Report Number: 3004582654-2025-00034
• Device Sequence Number: 20839527
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280211
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 06/02/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 MO
• Patient Sex: Female
• Patient Weight: 9 KG