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); Encephalopathy (1833); Hemorrhage/Bleeding (1888); Renal Failure (2041); Patient Problem/Medical Problem (2688); Unspecified Nervous System Problem (4426)

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 between (b)(6) 2014 and (b)(6) 2017 regarding adverse events was retrospectively 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.These events were assessed and are being reported in response to an update to the mdr complaint sources.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.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)() initial.

Event Description

While supported by the tah-t, the patient has experienced the following adverse events as defined by intermacs: 24 days post implant - bleeding; 14 days post implant - psychiatric episode; 11 days post implant - renal dysfunction; 11 days post implant - bleeding; 155 days post implant - bleeding; 147 days post implant - infection/location: positive blood cultures/type: bacterial; 14 days post implant - neurological dysfunction - encephalopathy; 74 days post implant - other sae; 11 days post implant - pericardial drainage; 14 days post implant - psychiatric episode; 12 days post implant - renal dysfunction; 187 days post implant - other sae; 203 days post implant - other sae; 203 days post implant - other sae; 282 days post implant - other sae 364 days post implant - bleeding; 364 days post implant - infection/location: urinary tract/type: bacterial; 460 days post implant - bleeding; 460 days post implant - infection/location: positive blood cultures/type: bacterial; 499 days post implant - bleeding; 896 days post implant - bleeding.As of (b)(6) 2017 it was reported that the patient was still supported by the tah-t.

Manufacturer Narrative

Intermacs patient registry data collected from july 1, 2019 through september 30, 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.(b)(4) follow-up report 3.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 1650 days post implant - neurological dysfunction - cva i location: right hemisphere: temporal i severity: coma.The patient subsequently expired with a cause of death listed as nervous system: neurological dysfunction after 1669 days of tah-t support.

Manufacturer Narrative

Intermacs patient registry data collected from october 1, 2017 through december 31, 2018 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.(b)(4) (b)(6) follow-up report 1.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 988 days post implant - bleeding 988 days post implant - other sae as of (b)(6) 2018 it was reported that the patient was still supported by the tah-t.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 1421 days post implant - device malfunction and/or pump thrombosis.1496 days post implant - device malfunction and/or pump thrombosis.1547 days post implant - infection i location: positive blood cultures i type: bacterial.1580 days post implant - bleeding.As of june 30, 2019 it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Intermacs patient registry data collected from january 1, 2019 through june 30, 2019 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 5076 pt (b)(6) follow-up report 2.

• 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: 7647386
• MDR Text Key: 112707408
• Report Number: 3003761017-2018-00247
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 500101
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Weight: 33