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	Ischemia Stroke (4418)
Date of Event	08/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lvad 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 pump was exchanged on (b)(6) 2025.The event occurred on 2025-08-31,which is (20 days) after the pump was placed on the patient.We have reviewed the production records of the excor blood pump and the pump was produced according to our specification.Another adverse event that occurred on the same patient has been submitted as 3004582654-2025-00049.
Event or Problem Description
A physician contacted berlin heart gmbh clinical affairs (ca) on 2025-09-01 to report a new event on a patient who experienced subdural hematoma on (b)(6) 2025.After reducing anticoagulation, the size of the hematoma decreased.However, the ct scan on (b)(6) 2025 showed that there are low attenuating changes on the left side of brain, indicating an ischemic condition.The ischemic event appeared to have occurred 24 hours earlier.The patient was being supported with a lvad excor blood pump pu valves; 15 ml in/out; ø 9 mm, sn (b)(6).Small fibrin deposits were seen prior to the event.A pump change was performed on (b)(6) 2025.There are no more deposits and no deterioration in neurological status.

• 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: 23099812
• Report Number: 3004582654-2025-00050
• Device Sequence Number: 8685346
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 09/19/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 MO
• Patient Sex: Male
• Patient Weight: 10 KG