MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 50CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number	570500-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemolysis (1886); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	12/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The syncardia 50cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 50cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) initial.
Event or Problem Description
The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2020.The customer reported the cause of death as sepsis and other: pulmonary bleeding.Causes or contributing factors for the death were listed as persistent intrapulmonary bleeding after tracheotomy, bacterial and fungal sepsis, and hemolysis with high levels of bilirubin.The tah was not explanted and not autopsy was performed.No additional information has been provided at this time.

• Brand Name: SYNCARDIA 50CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Common Device Name: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 11032624
• Report Number: 3003761017-2020-00266
• Device Sequence Number: 1023927
• Product Code: LOZ
• UDI-Device Identifier: 00858000003053
• UDI-Public: (01)00858000003053
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 570500-001
• Device Lot Number: 115992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 29 YR