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	Thromboembolism (2654)
Date of Event	08/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 the site contacted to berlin heart clinical affairs to report that a patient, who was supported with an excor pediatric vad system, suffered several strokes with subsequent hemorrhagic conversion.On (b)(6) 2026 an arterial non-cns thromboembolism was identified in spleen, kidney, liver and mesenteric ileus.Small fibrin deposits were noted in the pump during other neurological events.The support was withdrawn and transitioned to palliative care on (b)(6) 2026.
Additional Manufacturer Narrative
The blood pump pu valves; 15 ml in/out; ø 9 mm, s/n 2530283 was placed on the patient on (b)(6) 2026 until the pump was explanted on (b)(6) 2026.The event occurred on (b)(6) 2026, which is 78 days after the pump was placed on the patient, who was being supported with an excor active driving unit.We have reviewed the production records of the excor blood pump.This pump was produced according to our specifications.

• 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: luis avila ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; +1(281)863-9712
• MDR Report Key: 50938067
• Report Number: 3004582654-2026-00051
• Device Sequence Number: 9563861
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: (01)04260090040157(17)280615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 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: 08/26/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: Life Threatening
• Patient Age: 22 MO
• Patient Sex: Male
• Patient Weight: 16 LB