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

Model Number 500101-001

Device Problems Restricted Flow rate (1248); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems High Blood Pressure/ Hypertension (1908); Pulmonary Dysfunction (2019); Patient Problem/Medical Problem (2688)

Event Date 12/30/2017

Event Type  Injury  

Manufacturer Narrative

The explanted right ventricle of the tah-t will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient was having episodes of very high pulmonary resistance and high central venous pressure, however, the lungs did not appear to be congested.The customer also reported that companion 2 driver settings were maximized and the waveforms on the driver indicated that the tah-t did not appear to be fully ejecting.The customer also reported that a fluoroscopy revealed that something could have been impinging on the right outflow valve.The customer also reported that the right ventricle of the tah-t was explanted and replaced.The customer also reported that the patient was stable and doing well with the replaced right ventricle.

Manufacturer Narrative

The following sentence was incorrectly stated in the follow-up report 1: the blood diaphragm (bd) was visually inspected and revealed multiple torn layers of the bd interfering with the movement of the outflow valve.The corrected sentence is as follows: the blood diaphragm (bd) was visually inspected and revealed a tear which interfered with the movement of the outflow valve.

Manufacturer Narrative

The 70cc tah-t l/n 099394 right ventricle id: 096619r1114 was returned to syncardia for evaluation.An explant analysis was performed to evaluate the integrity and function of the diaphragm, as well as the functionality of the valves.Visual inspection of the outside of the tah-t found no anomalies or defects.The valve inspection evaluates natural movement to determine if any defects may have been present, preventing them from moving freely as intended.Upon functional evaluation, it was noted that there was obstruction of the outflow valve from within the ventricle, causing the valve disc to not be able to move naturally, thus confirming the customer-reported issue.The blood diaphragm (bd) was visually inspected and revealed multiple torn layers of the bd interfering with the movement of the outflow valve.The ventricle was sent for evaluation by a contract laboratory that had previously conducted tah-t diaphragm analyses.The report from the contract laboratory concluded that the root cause of the bd failure was thinning of the blood diaphragm likely attributable to contact abrasion between the bd and first intermediate diaphragm.There was no evidence of defect in the tah-t ventricle materials or in ventricle construction.Syncardia has a corrective and preventive action (capa) to identify appropriate actions to prevent contact abrasion excess wear.The customer reported to syncardia that the patient subsequently expired on (b)(6) 2018 (tah-t l/n 107141; mfr.Report 3003761017-2018-00213) and listed the device malfuntion of the previously implanted right ventricle of the tah-t (l/n 099394) as a contributing cause to the patient's multi-organ failure, which was listed as the patient's cause of death.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

• 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: 7167770
• MDR Text Key: 96495573
• Report Number: 3003761017-2018-00011
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 099394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR