MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 50CC OR 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 50CC OR 70CC

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

Patient Problems Bacterial Infection (1735); Hemolysis (1886); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.Investigation summary: 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.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)(6).

Event Description

While supported by thetah-t, the patient has experienced the following adverse events as defined by intermacs: 5 days post implant - renal dysfunction.212 days post implant - renal dysfunction.217 days post implant - psychiatric episode.281 days post implant - infection i location pump/related - drive line i type: bacterial.294 days post implant - device malfunction and/or pump thrombosis.As of september 30, 2020 it was reported that the patient was still supported by a tah-t.

Event Description

Since the last reporting period, the patient experienced the following adverse event as defined by intermacs: 305 days post implant - device malfunction and/or pump thrombosis.As of march 31, 2021, it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Additional information has been provided in section b5 and h6.Intermacs patient registry data collected from october 1, 2020 through march 31, 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.(b)(4).

Manufacturer Narrative

Intermacs patient registry data collected from april 1, 2021 through june 30, 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 (b(4) pt (b)(6) follow-up report 2.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 400 days post implant - device malfunction and/or pump thrombosis.404 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) 2021, it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Additional information has been provided in section b5 and h6.Intermacs patient registry data collected from (b)(6) 2021 through (b)(6), 2022 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.Ra-1788 pt 122397 (di_263) follow-up report 3.

Event Description

During the last reporting period, it was reported that the patient had experienced the following adverse events as defined by intermacs.7 days post implant - hemolysis.20 days post implant - hemolysis.20 days post implant - hypertension.20 days post implant - hypertension.20 days post implant - infection.21 days post implant - hypertension.24 days post implant - hemolysis.33 days post implant - hemolysis.90 days post implant - hemolysis.344 days post implant - hemolysis.561 days post implant - hemolysis.561 days post implant - right heart failure.As of (b)(6) 2022, it was reported that the patient was still supported by the tah-t.

Manufacturer Narrative

The syncardia 50cc or 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 50cc or 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 october 01, 2022 through december 31, 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-ton-one correlation could not be made between the patient and the lot number of the implanted heart.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 (see section b7), 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.Emdr pt 122397 (di_263) follow-up report 4.

Event Description

During the last reporting period, it was reported the patient experienced the following adverse events as defined by intermacs: 838 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) 2022 it was reported that patient was still supported by the tah-t.

• Brand Name: SYNCARDIA 50CC OR 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 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11760915
• MDR Text Key: 248521521
• Report Number: 3003761017-2021-00075
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003053OR(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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/22/2023

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 Model Number: 50CC OR 70CC
• Device Catalogue Number: 570500-001 OR 500101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American