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

Catalog Number 570500-001 OR 500101

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

Patient Problems Hemolysis (1886); Renal Impairment (4499)

Event Type  Injury  

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 (b)(6) 2022 through (b)(6) 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.Pt 133962 initial.

Event Description

While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 2 days post implant - renal dysfunction, 7 days post implant - hemolysis, 12 days post implant - neurological dysfunction,15 days post implant - neurological dysfunction.The patient subsequently received a heart transplant after 21 days of tah-t support.

• Brand Name: SYNCARDIA 50CC OR 70CC TEMPORARY 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: 17191679
• MDR Text Key: 317816634
• Report Number: 3003761017-2023-00094
• Device Sequence Number: 1
• Product Code: LOZ
• 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
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 570500-001 OR 500101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• 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: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White