MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

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

Patient Problems Death (1802); Renal Failure (2041); Sepsis (2067); Depression (2361)

Event Date 04/06/2019

Event Type  Death  

Manufacturer Narrative

The tah-t was explanted and will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient died on (b)(6) 2019.The customer also reported the patient had elevated liver enzymes and lactate, and had complained of abdominal pain.The results of a subsequent exploratory laparotomy indicated there was no evidence of ischemia, but his gallbladder was removed.The patient's state did not improve after this procedure and he remained acidotic.The customer also reported the patient exhibited clinical depression associated with passive suicidal ideation.Per the patient's and the family's wishes, the decision was made to turn off the tah-t after 12 days of support.The customer listed the cause of death as hepatorenal failure with additional comments/observations of necrotic liver and sepsis and that the tah-t did not cause or contribute to the patient death.The customer also reported that the tah-t was explanted and that no autopsy was performed.No further information has been provided at this time.

Manufacturer Narrative

The customer did not report a device malfunction and attributed the cause of death to hepatorenal failure with necrotic liver and sepsis.The tah-t was explanted following the autopsy and returned to syncardia for evaluation.Visual inspection, valve evaluation, thrombus formation evaluation, and a stroke volume evaluation were performed during the tah-t explant analysis.No anomalies or abnormalities were observed.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8565153
• MDR Text Key: 143569668
• Report Number: 3003761017-2019-00070
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 116752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR