MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART; BIVENTRICULAR REPLACEMENT DEVICE

Model Number 595000-001

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

Patient Problems Death (1802); Respiratory Failure (2484); Multiple Organ Failure (3261)

Event Date 03/01/2020

Event Type  Death  

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.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.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient died on (b)(6) 2020.The customer reported the cause of death as multi-organ system failure with worsening hypoxemic respiratory failure requiring v-v ecmo post tah-t implant.They also reported focal subarachnoid hemorrhage around the cerebellum and within the basal cisterns; death was distributive shock and hypoxemia in spite of v-v ecmo.The tah was explanted and an autopsy was performed on (b)(6) 2020.No further information has been provided at this time.

Manufacturer Narrative

The explant analysis of the temporary total artificial heart evaluated the function of the diaphragms, the function and condition of the valves, as well as the overall condition of the heart.Visual inspection of the temporary total artificial heart found no anomalies or defects.No abnormalities or defects were found with the valves or the diaphragm.The diaphragm was visually inspected for any anomalies or defects, as well as tested for strength of stroke volume.Both the left and right ventricle diaphragms were free of defects, and both performed as intended during stroke volume testing.Scoring of the physical condition, functionality, and performance of the temporary total artificial heart determined that the temporary total artificial heart was functioning as intended while implanted, and there is no evidence of a device malfunction.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.(if new or additional information is received in the future, syncardia will file a follow-up mdr.) (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson, az AZ
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, az ; 5451234120
• MDR Report Key: 10197692
• MDR Text Key: 196544659
• Report Number: 3003761017-2020-00143
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 595000-001
• Device Catalogue Number: 500101
• Device Lot Number: 120591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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): Death
• Patient Age: 39 YR
• Patient Sex: Male