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 Death (1802); Hemorrhage, Cerebral (1889)

Event Date 03/31/2020

Event Type  Death  

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 tah-t was not explanted, therefore it was not returned to syncardia for evaluation.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.Ce (b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient presented to (b)(6) health emergency department on (b)(6) 2020 with fever and malaise.Due to developing a fever with unknown source, and a medical history significant for a total artificial heart (tah-t), he was admitted to the cardiac surgery icu.Blood cultures were drawn, as was covid-19 panel (which resulted as negative) and he was started on broad spectrum antibiotics.On (b)(6) 2020, his level of care changed from intensive care to "step down unit." on (b)(6) 2020, patient received a mid-line catheter, which was intended to be used for long term anti-biotic therapy.On the morning of (b)(6) 2020 last known time with no issue was 0430.Patient was noted to have acute left sided decorticate posturing, left facial droop, left gaze palsy and left sensory loss around 0815 on (b)(6) 2020.He was emergently taken to the ct scan with the neurology-stroke team and was noted to have a large, acute, right parietal intraparenchymal hemorrhage with ventricular extension, with associated mass effect.He was taken for a second ct scan later that afternoon and was noted to have an enlargement of the right frontoparietal parenchymal hematoma, progression of intraventricular blood products and increase in right-to-left midline shift.Per discussion with neurosurgery, his stroke was catastrophic and terminal.Patient's family was contacted immediately after the stroke on (b)(6) 2020 and on (b)(6) 2020 the family decided to turn off his total artificial heart.The customer reported the cause of death as stroke and that the tah-t did not cause or contribute to the patient death.The tah-t was not explanted and no autopsy was performed.No additional information has been provided at this time.

• 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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, az ; 5451234120
• MDR Report Key: 9967957
• MDR Text Key: 187905428
• Report Number: 3003761017-2020-00110
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 116755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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: 48 YR