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 Hemorrhage/Bleeding (1888)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The syncardia 70 cc 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 70 cc 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 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).

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6) 2021 the patient was in a stepdown unit and had little to no output with his tah-t while supported by a companion 2 driver.The medical staff started the patient on pressors (medication to increase blood pressure) and intubation.The blood pressure did not change with the pressors or fluids; patient had jugular vein distention (jvd).The patient was brought to cvicu where his chest was opened and showed bleeding from the suture line left cuff and a clot surrounding the right atrium.The clot was evacuated and the area repaired.The patient was discharged home on a freedom driver on (b)(6) 2021.The customer also reported that the patient presented to the er in early hours of (b)(6)2021 with shortness of breath; his level of consciousness rapidly deteriorated requiring intubation.The freedom driver fill volume and cardiac output dropped and the driver was alarming.Fluid resuscitation of 3l lactated ringers was initiated with little to no effect.The patient was brought to cvicu and placed on a companion 2 driver.A transesophageal echocardiogram (tee) was performed which showed bleeding from same area around left side of heart and a clot surrounding right atrium.This is similar to the event on (b)(6) 2021.The patient was brought to the or where his chest was opened, the clot evacuated and the area repaired.As of 1830 on (b)(6) 2021, the patient is in cvicu stable with improving fills.He received blood products.

• 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: 12673412
• MDR Text Key: 277677582
• Report Number: 3003761017-2021-00200
• 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
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 116753
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 40 YR