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	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6) was placed on the patient on (b)(6) 2026, the same day as the event.The patient 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 (b)(6) 2026 to report that a patient underwent an excor blood pump exchange due to clot formation on the posterior aspect of the outflow on (b)(6) 2026.Following completion of the pump exchange and dressing change, the patient became acutely unresponsive, with signs of poor perfusion and minimal respiratory effort.The patient was noted to be acidotic with a lactate of 13 and was subsequently intubated for respiratory failure.Head ct and head ultrasound were performed on the same day of the event.The ct result showed new hypoattenuation of the left caudate head/basal ganglia likely representing interval infarction.No evidence of intracranial hemorrhage.No significant mass effect.The head ultrasound demonstrated increased echogenicity in the left caudate head, concerning for possible ischemia.An additional head ct showed increased echogenicity in the left caudate head, concerning for possible ischemia.The excor blood pump pu valves; 10 ml in/out; ø 6 mm, s/n (b)(6) functioned as intended with complete fill and ejection.Fibrin was noted at the outflow valve of the pump.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 25143840
• Report Number: 3004582654-2026-00028
• Device Sequence Number: 13147460
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)280314
• 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): 05/11/2026

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: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: 1 MO
• Patient Sex: Male
• Patient Weight: 4 KG