MAUDE Adverse Event Report: SynCardia Systems, LLC SynCardia Total Artificial Heart (STAH); Biventricular Replacement Device

Catalog Number	P/N 500101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	07/26/2025
Type of Reportable Event	Death
Event or Problem Description
Per hospital staff, patient was diagnosed with sepsis and the determination was made to remove the patient from stah support by the patient and their family.The patient was removed from support in hospital.The device was stated to not have contributed or caused the patient death.
Additional Manufacturer Narrative
Per hospital staff, patient death was determined to be unrelated to the device, the patient was removed from support after a diagnosis of sepsis.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• Brand Name: SynCardia Total Artificial Heart (STAH)
• Common Device Name: Biventricular Replacement Device
• Manufacturer (Section D): SynCardia Systems, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SynCardia Systems, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; +1(520)545-1234
• MDR Report Key: 50311905
• Report Number: 3003761017-2025-00126
• Device Sequence Number: 21298196
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Catalogue Number: P/N 500101
• Device Lot Number: 128318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 61 YR
• Patient Sex: Male