MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	C22A-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	04/05/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The patient was implanted with a total of four cannulae on (b)(6) 2025 as follows: the lvad excor apex cannula for children ø 12/9 mm (c22a-004); l 27 cm; lot no.00145787.The lvad arterial cannula for small children ø 6 mm; l 25 cm (c80g-021m); lot no.00125255.The rvad atrial cannula ø 12/9 mm; l 32 cm; head 23 mm (c23v-004m); lot no.00145788.The rvad arterial cannula for small children ø 6 mm; l 25 cm (c80g-021m); lot no.00148388.The cannulae were in use on the patient from on (b)(6) 2025 until they were removed from the patient on (b)(6) 2025.The event occurred on 2025-04-05, which is (87 days) after the cannulae were placed on the patient.The details of the lvad apex cannula lot no.00145787 are provided in section d4.The information of the other three cannulae used on the patient are as follows: the cannula c23v-004m with lot no.00145788: the manufacture date for this lot: 2024-08-29, the expiration date for this lot: 2027-07-25, udi: (b)(4).The cannula c80g-021m with lot no.00125255: the manufacture date for this lot: 2022-11-03, the expiration date for this lot: 2025-09-30, udi: (b)(4).The cannula c80g-021m with lot no.00148388: the manufacture date for this lot: 2024-10-25, the expiration date for this lot: 2027-10-02, udi: (b)(4).We have reviewed the production records of the excor cannulae and the cannulae were produced according to our specifications.
Event or Problem Description
Berlin heart gmbh clinical affairs was informed by the clinic on 2025-07-17 that a patient suffered an hemorrhagic stroke after receiving fibrinolytics for a clot in one of the cannulae.As a result, the patient was declared brain dead.Care was withdrawn from the patient on (b)(6) 2025.The patient was being supported with the excor system in bi-vad configuration.Deposits were noted in the excor cannulae.

• 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: 22786576
• Report Number: 3004582654-2025-00045
• Device Sequence Number: 8256660
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: (01)04260090040492(17)270725(10)00145787
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: C22A-004
• Device Lot Number: 00145787
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: Death
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 12 KG