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

Model Number 397002-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Death (1802); Hemolysis (1886); Hemorrhage, Cerebral (1889); Sepsis (2067)

Event Date 10/12/2019

Event Type  Death  

Manufacturer Narrative

The customer-reported patient hemolysis caused by a possible device malfunction was unable to be confirmed.A device malfunction could not be reproduced during investigation testing using the patient simulator because the dmc tank contains water, not blood; therefore, hemolysis cannot be assessed.During functional testing, the driver passed all test steps.The driver was further subjected to an additional 72-hour observation run in an attempt to observe a possible malfunction or change in driver performance.The driver performed as intended, and there was no evidence of a device malfunction.Syncardia is aware that all mechanical circulatory support devices may contribute to hemolysis and is continuing to study the impact of the tah-t system on the reported experience.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient in general was not doing well, developed hemolysis (ldh values increased over time to approximately 6000 u/l), and had a severe infection requiring intensive care treatment while supported by the companion 2 driver.The customer also reported that the patient was subsequently switched to the backup driver.The patient condition did not significantly improve, but the ldh levels came down to approximately 4000 u/l.

Event Description

The customer, a syncardia certified hospital, reported that the patient in general was not doing well, developed hemolysis (ldh values increased over time to approximately 6000 u/l), and had a severe infection requiring intensive care treatment while supported by the companion 2 driver.The customer also reported that the patient was subsequently switched to the backup driver.The patient condition did not significantly improve, but the ldh levels came down to approximately 4000 u/l.Subsequently the patient expired due to massive cerebral bleeding following a septic episode.

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.The tah-t was not returned to syncardia for evaluation.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.A definitive root cause cannot be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

Manufacturer Narrative

Corrected sections b2 and d4.(b)(4), 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 AZ 85713
• MDR Report Key: 9296319
• MDR Text Key: 165600815
• Report Number: 3003761017-2019-00309
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 397002-001
• Device Catalogue Number: 500101
• Device Lot Number: 109481
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 10/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 54 YR