MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

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.Investigation summary: intermacs patient registry data collected from (b)(6) 2019 through (b)(6) 2020 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.(b)(4).

Event Description

While supported by thetah-t, the patient has experienced the following adverse events as defined by intermacs: 18 days post implant - infection i location other i type: bacterial.18 days post implant - respiratory failure.150 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) 2020 it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Intermacs patient registry data collected from (b)(6) 2020 through (b)(6)2021 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.Ce 5660 pt (b)(6) follow-up report 1.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 122 days post implant - infection.139 days post implant - neurological dysfunction.138 days post implant - respiratory failure.197 days post implant - neurological dysfunction.197 days post implant - respiratory failure.138 days post implant - device malfunction and/or pump thrombosis.The patient subsequently expired with a cause of death listed as wihdrawal of support after 203 days of tah-t support.

• 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: 11760914
• MDR Text Key: 248572635
• Report Number: 3003761017-2021-00076
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Weight: 86