MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 50CC OR 70CC TEMPORARY TOTAL 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); Hemorrhage/Bleeding (1888); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 2 days post implant - bleeding, 3 days post implant - renal dysfunction, 6 days post implant - hemolysis, 18 days post implant - device malfunction and/or pump thrombosis, 19 days post implant - hemolysis, 34 days post implant - infection, 40 days post implant - neurological dysfunction, 52 days post implant - bleeding.The patient subsequently received a heart transplant after 91 days of tah-t support.

Manufacturer Narrative

The syncardia 50 cc or 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 50 cc or 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 (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, 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).

• 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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15631893
• MDR Text Key: 301999560
• Report Number: 3003761017-2022-00117
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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: 09/20/2022
• 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: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White