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

Catalog Number 500101

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Pulmonary Edema (2020)

Event Date 11/29/2019

Event Type  Death  

Manufacturer Narrative

The tah-t was not explanted, therefore it will not be returned to syncardia for evaluation.Syncardia has requested the two freedom drivers, the companion 2 driver and the tah-t left ventricle cpc connector be returned for evaluation.The results of these evaluations will be provided in a follow-up mdr.Ce 5101 initial.

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6) 2019 the patient was admitted through the emergency department for abdominal migraines.There were no abnormal lab results, radiology exams or freedom driver device parameters at the time of admission.The patient was admitted to the routine device and advance heart failure floor.The hospital also reported that the patient had been admitted 2 weeks prior for the same ailment and a subtherapeutic inr which when she was discharged three weeks prior to that admission was therapeutic.The customer also reported that on (b)(6) 2019, the patient's mother heard an air leak coming from the connection between the tah-t cannula and freedom driver s/n (b)(4) and switched the patient to freedom driver s/n (b)(4).A few minutes later the vad team was called to assess continued air leaking.The vad team called the syncardia hotline and was connected with a syncardia clinical specialist to report that the patient's left ventricle cannula side cpc connector had an air leak and displaced spring and that freedom driver s/n (b)(4) was alarming.Per instructions between the syncardia clinical specialist and the hospital staff, the cpc connector was replaced and the patient switched to companion 2 driver s/n (b)(4) without incident and patient was hemodynamically stable.Approximately one hour later, the customer called the syncardia clinical specialist again to report that the patient was experiencing severe deterioration and univentricular presentation of the left ventricle not able to empty with parameter adjustments of the companion 2 driver.The patient had been intubated for airway management and acute hemodynamic collapse requiring neosynephrine and vasopressin infusions to maintain a blood pressure of 70/40-80/50.The patient was transferred to the surgical icu where she continued to decompensate and was in pulmonary edema with adequate but decompensating gas exchange.Syncardia clinical specialists (on site and off site) reviewed the companion 2 driver waveforms and patient data files and determined the driver was performing as intended with no evidence of a malfunction.The hospital continued with medical management of patient as she continued to decompensate.Using external echocardiogram (echo) and internal transesophageal echocardiography (tee), the hospital intensivist had been able to assess that there was no external tamponade (ivc, svc, pulmonary veins are patent and clearly demonstrating pulmonary edema).The hospital intensivist went on to describe visualization of the suture lines of the outflow grafts on both pulmonary artery and aorta with no collections.He did describe very high velocities exiting the aorta valve of the left ventricle pump > 500 cm2/m2/sec).The hospital deduced a device outflow obstruction and recommended immediate va ecmo and potential replacement of the left ventricle.The medical team met with the family and it was determined that there would be no further surgical interventions.If the family chose to have an autopsy, syncardia communicated that they would appreciate the opportunity to evaluate the tah-t performance.The customer reported tah-t support was withdrawn at 11:41pm on (b)(6) 2019, the tah-t was not explanted and no autopsy was performed.No further information has been provided at this time.

Manufacturer Narrative

The tah-t was not explanted and therefore was not returned to syncardia for evaluttion.The patient's two freedom drivers, the companion 2 driver and the tah-t left ventricle cpc connector were returned for evalution.The results of these evaluations are provided below.A family member reported hearing an air leak sound and switched the patient from freedom driver s/n (b)(6) to freedom driver s/n (b)(6).Freedom driver s/n (b)(6) was tested and determined to function as intended.There were no recorded alarms and no evidence to indicate that there was an air leak on the freedom driver drivelines.This does not preclude the possibility of a leak in the tah-t cannula; however, as the tah-t was not returned for evaluation, it is difficult to determine if the family-reported air leak came from the cannula.Later in the day, the hospital reported hearing an air leak sound and also reported that freedom driver s/n (b)(6) was exhibiting an alarm.The freedom driver was tested and determined to function as intended.The driver's alarm history recorded a '49' alarm code.This code is indicative of cardiac output too low for long enough to permanently time-out which is most likely the customer-reported alarm.It can be produced by an air leak, kinked hose, hypervolemia, hypertension or if the driver is left powered on for over 4 minutes after removal from patient.Additional testing and investigations determined that a leak from the freedom driver drivelines was highly unlikely.The tah-t cpc connector from the cannula was returned attached to the freedom driver s/n (b)(6) drivelines.The driver was tested with this connector in line and no leaks or anomalies were observed other than a displaced spring on the tah cpc connector.Based on testing performed during this investigation it is highly unlikely that the displaced spring contributed to an air leak.Again, this does not preclude the possibility of a leak in the tah-t cannula; the low cardiac output alarm recorded in this driver is indicative of an air leak.The tah-t cpc connector was replaced and the patient switched to companion 2 driver s/n (b)(6) without incident.Companion 2 driver s/n (b)(6) was tested and determined to function properly.Once the patient was connected to companion 2 s/n (b)(6) the results of the low cardiac output state on the left line could be seen at startup.The left ventricle did not have a full eject flag and was full filling on each stroke.If the tah-t system was in a low cardiac output state, this could in turn result in stagnant blood in the ventricle.This low flow state could then lead to an obstruction in the ventricle preventing full eject and resulting in full fill.The inability to fully eject from the left ventricle will result in congestion of the pulmonary bed resulting in flash pulmonary edema.If this is not corrected in a timely manner it could lead to circulatory collapse and death of the patient.The medical staff then used an external echocardiogram (echo) and internal transesophageal echocardiography (tee) to further asses the patient.The hospital intensivist had been able to assess that there was no external tamponade (ivc, svc, pulmonary veins are patent).The hospital intensivist went on to describe visualization of the suture lines of the outflow grafts on both pulmonary artery and aorta with no collections.He did describe very high velocities exiting the aortic valve (> 500 cm2/m2/sec).The hospital reported that they deduced that there was a device outflow obstruction.Syncardia did request that the tah-t be returned for evaluation, however, the patient's family declined an autopsy.Despite the adverse event it was determined that all drivers functioned as intended and that any leaks that had occurred were unidentifiable within the hardware that was returned to syncardia.Syncardia does have corrective and preventive action (capa) for the issue of displace springs in cpc connectors.Syncardia has completed its investigation and is closing this file.Ce (b)(4) follow-up report 1.

• 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
• MDR Report Key: 9528376
• MDR Text Key: 172995073
• Report Number: 3003761017-2019-00368
• Device Sequence Number: 1
• Product Code: LOZ
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 500101
• Device Lot Number: 107693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 22 YR