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); Brain Injury (2219)

Event Date 03/31/2020

Event Type  Death  

Manufacturer Narrative

The 70cc tah-t will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce (b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that patient was readmitted to the hospital after she was found unresponsive by her sister around 430 am on (b)(6) 2020 and brought in by ems.She was intubated and ventilated and responded to painful stimuli.Ct head showed no intracranial abnormalities.Ct chest appeared negative for a pulmonary embolism.Ct abdomen and pelvis showed moderate abdominal free fluid mildly hyperdense may be hemorrhagic fluid.No acute processes were noted on the ct scan.There was moderate semi-opaque free fluid in the abdomen.Perfusion appeared to be intact.Profoundly altered mental status.The customer also reported that when the patient was found unresponsive there was bloody sputum coming from the nose and mouth, cyanotic, the freedom driver was pumping and that there was no mention of whether or not patient was found lying on the drive lines.The customer also reported that the patient tested negative for covid-19.The customer also reported that support was withdrawn on (b)(6) 2020 at 1810.The cause of death was listed as anoxic brain injury and that the device did not cause or contribute to the patient death.An autopsy was performed and the tah-t was explanted.

Manufacturer Narrative

The customer did not report a device malfunction and attributed the cause of death to anoxic brain injury.The tah-t was explanted following the autopsy and returned to syncardia for evaluation.Visual inspection, valve evaluation, thrombus formation evaluation, and a stroke volume evaluation were performed during the tah-t explant analysis.No anomalies or abnormalities were observed.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.(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
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 9997772
• MDR Text Key: 188899675
• Report Number: 3003761017-2020-00106
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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: 117470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Death
• Patient Age: 61 YR
• Patient Sex: Female