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	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm, s/n (b)(6) was used on the patient from (b)(6) 2026 until the patient was transplanted on (b)(6) 2026.The event occurred on (b)(6) 2026, which is (47 days) after the pump was placed on the patient, who is being supported with an excor ikus driving unit.We have reviewed the production records of the excor blood pump.This pump was produced according to our specifications.
Event or Problem Description
The site contacted berlin heart clinical affairs (ca) on 2026-04-03 to report that a patient experienced stroke related to clinical focal seizure with left arm and facial jerking on (b)(6) 2026.A ct scan performed on the date of the evet revealed right parietal mca territory infarct in setting of decreased opacification of the right posterior right m3 and m4 branches.Thee result of the following scan showed an evolving right posterior mca territory infarct with persistent, though less conspicuous loss of grey-white differentiation in the posterior right, frontal, parietal, and temporal lobes.The excor blood pump functioned as intended with complete fill and ejection.A small white fibrin was noted at the outflow connector and inflow connector.The patient was successfully transplanted on (b)(6) 2026.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• MDR Report Key: 25052271
• Report Number: 3008454189-2026-00006
• Device Sequence Number: 9353993
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026
• Report Date (Section F): 04/30/2026

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: 05/18/2026
• Device Model Number: P15P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/03/2026
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• 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: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG
• Date Report Sent to FDA: 04/30/2026