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
• MDR Report Key: 25143929
• Report Number: 3008454189-2026-00007
• Device Sequence Number: 18486496
• 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
• 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): 05/11/2026
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• 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: 1 MO
• Patient Sex: Male
• Patient Weight: 4 KG
• Date Report Sent to FDA: 05/11/2026