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	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump pu valves; 15 ml in/out; ø 9 mm; sn (b)(6) was in use on the patient from 2025-04-05 up to date.The event occurred on 2025-05-09,which is (34 days) after the pump was placed on the patient.The pump continues to remain on the patient.We have reviewed the production records of the excor blood pump and concluded that the pump was produced according to our specification.
Event or Problem Description
The site contacted berlin heart inc (bhi) clinical affairs (ca) on 2025-05-13 to report that the patient supported with excor blood pump pu valves; 15 ml in/out; ø 9 mm; was noted to have left facial drooping, left upper and lower extremity weakness on 2025-05-09.On the same day, a ct scan, with and without contrast as well as perfusion scan were performed, and the results showed no acute abnormality.There was a chronic right parietal infarct.This was new from the previous ct, which showed a perfusion abnormality in the region.According to the site, the excor blood pump performed as intended with complete filling and ejection.The pump was noted to have deposits 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 22176461
• Report Number: 3004582654-2025-00029
• Device Sequence Number: 15403527
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)270518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2025

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 Model Number: P15P-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: 05/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 9 MO
• Patient Sex: Female
• Patient Weight: 8 KG