MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 50CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 570500-001

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2022

Event Type  Death  

Manufacturer Narrative

The syncardia 50cc 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 50cc 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.If new or additional information is received in the future, syncardia will file a follow-up mdr.

Event Description

On (b)(6) 2022, the customer, a syncardia certified hospital, reported that the patent had passed away over the weekend.The customer has since indicated that a post mortem is being performed and additional information regarding the possible cause of death will be provided at a later date.The customer has also indicated that if they receive the tah-t, it will be sent to syncardia for evaluation.Syncardia director global clinical affairs received an email from the patient's wife informing syncardia that they suspect it was a perforation in the device diaphragm but will not know for sure until the post mortem.The patient collapsed on saturday morning and ct revealed a diffuse spread of air throughout his brain preventing blood flow.Over the day, organs began to shut down and once his diastolic pressure dropped below 30, the c2 was shut down.Note: the hospital has not provided syncardia confirmation of the medical information provided in the wife's email.

Event Description

On 07sep2022 syncardia received information from the hospital regarding the patient's death and tah-t analysis.In the report the hospital stated: "the patient underwent tah support for a period of 38 months during which a number of complications were experienced three of which i believe are particularly relevant to this investigation: i) on the penultimate itu admission the patient had episodes of hypoxia.A bubble echocardiographic study confirmed the presence of an inter-atrial communication.The hypoxia was attributed to right-to-left shunting of blood; ii) the patient experienced chronic respiratory issues and required bipap support at night; iii) immediately prior to their demise, the patient had undergone renal replacement therapy by means of haemofiltation during a readmission episode at (b)(6) hospital and had an intravenous vascath catheter in situ.On (b)(6) 2022 at around 05:30, at the end of a haemofiltration session, the patient deteriorated abruptly, lost consciousness, underwent resuscitation and a had a ct scan of the head which demonstrated diffuse and extensive air embolisation of the brain.The patient died later the same day.".

Manufacturer Narrative

The hospital conducted an autopsy and testing on the patient's explanted tah-t.The hospital's report states: "in conclusion, i do not believe that failure of the tah was the cause of the systemic arterial gaseous embolization which caused the patient's death.Nor do i believe that air was entrained through the inflow anastomoses of either the left or the right sided pump.Nor do i believe that death can be attributed to an atrio-oesophageal fistula.The only plausible mechanism is iatrogenic air entry via an unoccluded venous catheter.However, this could only have happened if the venous pressure was extremely low and the left atrial pressure was even lower which makes me doubtful that this actually occurred.In summary, on balance of probability i do not believe that there is sufficient evidence to suggest that air entrainment through an open venous line was the cause of gaseous arterial embolisation leading to the patient's demise." syncardia has repeatedly asked for the return of the patient's explanted tah-t so that it can conduct its own investigation.If the tah-t is returned to syncardia, an explant analysis will be conducted to determined if there was a malfunction of the tah-t and if so, determine the root cause.(b)(4) follow-up report 1.

Manufacturer Narrative

Patient 20-tb expired on (b)(6) 2022 after 1149 days of tah-t support.An autopsy and explant of the 50cc tah-t was performed at harefield hospital on (b)(6) 2022.See attached letter of analysis dated (b)(6) 2022.The explanted tah-t was subsequently returned to syncardia and was received on 18nov2022.Visual inspection of external components including the left and right tah-t assemblies showed no visible damage to ventricles or cannulae.Visual inspection of internal components found no visible tears, holes, or other damage of any sort to any of the diaphragm layers of either ventricle.A stroke volume test was performed on both ventricles following the visual inspection.In this test, water displacement is observed when pressure is applied to each ventricle inside a closed system.When tested the left ventricle displaced 48cc and the right displaced 47cc.Both of these are within the +/- 10% tolerance acceptability (45cc - 55cc) so both ventricles can be said to be fully functioning as intended.Explant analysis completed at syncardia to specifically evaluate the diaphragms and conduct a stroke volume test found no abnormalities with any part of the tah-t, including the diaphragms and both ventricles.Functional testing found the device performed within specification during the stroke volume test.Failure investigation and product evaluation for this complaint did not confirm the reported issue and found no evidence of a device malfunction.Assigned cause of death is unknown as patient outcome form has not been received to date though requested multiple times by syncardia.Tah-t performed as designed.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 aditional information is received in the future, syncardia will file a follow-up mdr.) (b)(4) follow-up report 3.

Manufacturer Narrative

The tah-t was received at syncardia on 18nov2022 and is awaiting investigation.B)(4) follow-up report 2.

• Brand Name: SYNCARDIA 50CC 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 14497789
• MDR Text Key: 292686604
• Report Number: 3003761017-2022-00052
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 570500-001
• Device Lot Number: 111146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR
• Patient Sex: Male