MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Death  

Manufacturer Narrative

The tah-t was explanted and will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2020.The customer did not report a cause of death.The customer also reported that the tah-t was explanted and an autopsy was performed.No additional information has been provided at this time.

Manufacturer Narrative

The syncardia 70cc 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 70cc 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.The explant analysis of the tah-t evaluated the function of the diaphragms, the function and condition of the valves, as well as the overall condition of the heart.Visual inspection of the tah-t found no anomalies or defects.The valve inspection evaluates natural movement to determine if any defects may have been present, preventing them from moving freely as intended.No abnormalities or defects were found with the valves.The diaphragm was visually inspected for any anomalies or defects, as well as tested for strength of stroke volume.Both the left and right ventricle diaphragms were free of defects, and both performed as intended during stroke volume testing.Scoring of the physical condition, functionality, and performance of the tah-t determined that the tah-t was functioning as intended while implanted, and there is no evidence of a device malfunction.Based on the information provided by te customer, and evaluation completed, there is no indication of a device malfunction or performance issue of the device that would impact the reported event.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.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10663381
• MDR Text Key: 211282733
• Report Number: 3003761017-2020-00212
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 113821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female