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 01/22/2020

Event Type  Death  

Manufacturer Narrative

A syncardia clinical expert provided the following summary of events and clinical conclusion: summary of events: the patient was implanted with the 70cc tah-t on (b)(6) 2019.Prior to tah-t implant a head ct was obtained that revealed evidence of a small ischemic event.Of note, the patient required ecmo pre-implant.On or around (b)(6) 2020, the patient spiked a fever and was treated with antibiotics.Prior to this time, his inr had been stable at a level of approximately 2.5 on 4mg of coumadin.On (b)(6) 2020, the inr peaked at 6.24 which significantly increased the patient's risk of bleeding and may have been associated with the administration of antibiotics.Changes in the patient's neurological status were noted around the time that the patient spiked a fever.Neurology was consulted and determined the patient was having seizures.The patient was treated, and some improvement was noted.On (b)(6) 2020, the patient's neurological status was significantly worse, and he became nonresponsive.A ct scan was completed and revealed a hemorrhagic stroke which subsequently led to his death on (b)(6) 2020.Clinical conclusion: the events summarized above indicate that the most likely cause of the hemorrhagic stroke was the sharp increase in inr (anticoagulation) and may have been associated with the administration of antibiotics to treat the presumed infection.The timeline suggests that the cerebral bleeding may have started around (b)(6) 2020 and increased in severity over time as evidenced by the noted neurological changes which increased in severity.The tah-t does not appear to have caused or contributed to the hemorrhagic stroke and subsequent death of the subject.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 5172 initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient passed away on (b)(6) 2020.The customer reported the patient had an external brain stem bleed and that neurosurgery was unable to treat the patient.The customer also reported that the team discussed withdrawal of patient support.The customer reported the cause of death as intracerebral hemorrhage.The customer also reported that the tah-t was not explanted.No further 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: 9732504
• MDR Text Key: 180150591
• Report Number: 3003761017-2020-00036
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 110967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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