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

Model Number 500101-001

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

Patient Problem Inflammation (1932)

Event Date 07/29/2021

Event Type  Injury  

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 companion 2 driver system, used with the 50cc tah-t or the 70cc tah-t, is intended for use inside the hospital and on the hospital grounds.The freedom driver system, used with the 50cc tah-t or the 70cc tah-t, is intended for in-hospital and out-of-hospital use.The tah-t system with the syncardia freedom driver is indicated for use as bridge to transplant in cardiac transplant candidates who are implanted with the tah-t and are clinically stable.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.Even though the patient was hemodynamically unstable, the freedom driver continued to provide its life-sustaining function.On 07aug2021, the patient was subsequently discharged home in stable condition with no adverse effects and supported by a freedom driver.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 reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under four separate medical device reports: (1) 70cc tah-t l/n 113815 (mfr report # 3003761017-2021-00164); (2) companion 2 driver s/n 10176a (mfr report # 3003761017-2021-00160); (3) companion 2 driver s/n 10007a (mfr report # 3003761017-2021-00161); and (4) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2021-00162).The customer, a syncardia certified hospital, reported that companion 2 driver s/n (b)(4) (mfr report # 3003761017-2021-00160) exhibited a system malfunction alarm when a system check was performed on (b)(6) 2021 and a replacement driver was requested.This driver had previously passed a system check on (b)(6) 2021 therefore there was additional communication between the customer and syncardia to try and resolve the system malfunction alarm.The alarm was not resolved and a replacement driver was again requested on (b)(6) 2021.A replacement companion 2 driver was shipped on 28jul2021 from syncardia for overnight delivery but was delayed in memphis, tn by the transport company due to weather.Due to the delay, on (b)(6) 2021 syncardia coordinated the shipment of a companion 2 driver from another hospital, however, the customer reported that companion 2 driver s/n (b)(4) (mfr report # 3003761017-2021-00161), received on (b)(6) 2021, did not generate right side waveforms or data after it was powered on.The customer also reported that the patient received a transplant offer and was admitted on (b)(6) 2021.The patient was switched from his freedom driver to a companion 2 driver.The customer reported that companion 2 driver s/n (b)(4) (mfr report # 3003761017-2021-00162) had previously passed multiple system checks but exhibited a compressor malfunction alarm approximately 30 seconds after being attached to patient.The patient was subsequently switched back to a freedom driver and there was no reported adverse patient impact.The customer also reported to syncardia representative that the during the late afternoon/evening of (b)(6) 2021, the patient developed an inflammatory process in his abdomen and became hemodynamically unstable forcing admission to icu and the transplant was canceled (70cc tah-t l/n (b)(4).Additional companion 2 drivers were received on (b)(6) 2021 and the patient was switched from the freedom driver to a companion 2 driver for the week.Patient was switched back to freedom driver and remained in hospital for one day of observation.On (b)(6) 2021, the patient was subsequently discharged home in stable condition with no adverse effects and supported by a freedom driver.

• 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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: donald webber ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12379700
• MDR Text Key: 268697290
• Report Number: 3003761017-2021-00164
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 113815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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): Hospitalization
• Patient Age: 56 YR