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 Problems Aspiration/Inhalation (1725); Bacterial Infection (1735); Obstruction/Occlusion (2422)

Event Date 06/01/2021

Event Type  Death  

Manufacturer Narrative

Patient (b)(6) is a study subject in the (b)(6) study with cumulative 1931 days of support.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.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 Description

The customer, a syncardia certified hospital, reported that the patient had tested positive for corynebacterium in (b)(6) 2021 and this was the same bacteria attributed to his chronic driveline infection.The customer also reported that the patient passed away on (b)(6) 2021.The customer reported the cause of death as other: aspiration with causes or contributing factors to the death as small bowel obstruction and chronic driveline/pump infection.The customer also stated that the tah did not cause or contribute to the patient death; at the time of his death, his cultures were negative.The tah was explanted and a limited autopsy was performed.No additional information has been provided at this time.

Event Description

Syncardia received the medwatch form submitted by vcu risk management and it contained information regarding the performance of the tah-t that was previously unreported to syncardia - "post surgery, noted to have low flow on his total artificial heart with poor oxygenation and ventilation".Syncardia sent a second request to vcu for the return of explanted 70cc tah-t l/n 105701 and it was granted by vcu risk management with the condition that syncardia provide vcu health with a report of the findings upon completion of syncardia evaluation.

Manufacturer Narrative

The 70cc tah-t has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce (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
• MDR Report Key: 12094619
• MDR Text Key: 259225066
• Report Number: 3003761017-2021-00124
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 105701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 41 YR