MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH; 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	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	02/15/2025
Type of Reportable Event	Death
Event or Problem Description
Reported death of patient due to multi-system organ failure.Patient's family decided to withdraw care due to health status.No autopsy was performed, the device was not explanted, and hospital staff reported device did not cause or contribute to the patient's death.
Additional Manufacturer Narrative
Patient death due to multi-system organ failure.Patient's family made the decision to withdraw support.Device confirmed by hospital staff to not have caused or contributed to patient death.Device was not explanted and no autopsy was performed.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 70CC TAH
• 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 ; 5205451234
• MDR Report Key: 21428428
• Report Number: 3003761017-2025-00090
• Device Sequence Number: 20004600
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008(10)125566(11)220228(17)250331
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/20/2025

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
• Device Catalogue Number: P/N 500101
• Device Lot Number: 125566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 02/28/2022
• 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: 59 YR
• Patient Sex: Male