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	03/30/2025
Type of Reportable Event	Serious Injury
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 pump was replaced on (b)(6) 2025.The event occurred on 2025-03-30, which is (21 days) after the pump was placed on the patient and continued to remain on the patient for a further 1 day until the pump was exchanged.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 2025-03-31 regarding a pump change.Upon further conversation with the site and the review of the pump change record, it was noted that the patient had a stroke.On (b)(6) 2025, the patient had bilateral lower extremity twitching, right sided weakness, and right sided facial drooping.The patient remained alert and responsive with equal pupils, but symptoms persisted.Ct scan results showed multifocal acute infarcts in the middle cerebral artery (mca).Left greater than the right.No hematoma or midline shift.Severe stenosis vs.Occlusion at the left mca trifurcation.According to the site, the excor blood pump performed as intended with complete filling and ejection.The pump was noted to have fibrin on the lateral cusp of the outflow valve.

• 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: 21914165
• Report Number: 3004582654-2025-00023
• Device Sequence Number: 21093068
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)271002
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse Practitioner
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 03/31/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: 12 MO
• Patient Sex: Female
• Patient Weight: 8 KG