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	02/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 10 ml in/out; ø 6 mm; sn (b)(6) was in use on the patient from (b)(6) 2024 until the patient was transplanted on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (70 days) after the pump was placed on the patient.The pump continued to remain on the patient for a further 36 days until the patient was transplanted.The site notified the incident to berlin heart after the patient was recovered and transplanted.We have reviewed the production records of the excor blood pump, and it was produced according to our specification.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on 2025-03-27 to report that the patient being supported with an excor pediatric vad system presented with a right arm and facial twitching and seizure like activity on (b)(6) 2025.Ct scan showed subacute left mca territory stroke.An additional ct scan result showed the expected evolution of subacute left middle cerebral artery (mca) territory infarct with no hemorrhage.According to the site, the excor blood pump performed as intended with complete filling and ejection.Deposits were noted in the excor blood pump.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 21875115
• Report Number: 3008454189-2025-00008
• Device Sequence Number: 7653694
• Product Code: DSQ
• UDI-Device Identifier: 04260090040102
• UDI-Public: (01)04260090040102(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/21/2025
• Report Date (Section F): 04/21/2025

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 Expiration Date: 05/31/2026
• 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
• Distributor Facility Aware Date: 03/27/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• 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: 3 MO
• Patient Sex: Male
• Patient Weight: 4 KG
• Date Report Sent to FDA: 04/21/2025