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

Model Number	P10P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The berlin excor blood pump functioned as intended maintaining full fill and eject.Deposits were noted in the pump before and after the event.The excor blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6) was used on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2026, which is (30 days) after the pump was placed on the patient 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 (b)(6) clinical affairs (ca) on (b)(6) 2026 to report that the patient was presented with facial twitching and eye deviation on (b)(6) 2026.Head ct performed on the same day showed a subacute infarct in the left frontal lobe in the distribution of the anterior division of the left middle cerebral artery.There are small areas of subacute infarcts seen in a paramedian location of the right cerebral hemisphere consistent with watershed territory infarcts.There is no intraparenchymal hemorrhage, mass, or midline shift.There is no hydrocephalus or extracerebral fluid collection.The calvarium is intact.The visualized portions of the orbits, paranasal sinuses, mastoid air cells, and sella are normal.Cranial ultrasound showed no abnormalities.Upon eeg findings, there were numerous electrographic seizures independently arising from right and left central head region.These seizures occurred at a frequency of once in 2 hours with the last seizures occurred at the previous event.The berlin excor blood pump functioned as intended maintaining full fill and eject.Deposits were noted in the pump before and after the event.

• 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: 24309028
• Report Number: 3004582654-2026-00009
• Device Sequence Number: 9678699
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)280224
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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 Model Number: P10P-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: 01/21/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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: 2 MO
• Patient Sex: Female
• Patient Weight: 4 KG