MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problems Detachment Of Device Component (1104); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problems Embolism (1829); Thrombus (2101); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the patient was implanted with a temporary total artificial heart (tah-t) at the (b)(6).The customer reported that at the end of the tah implantation, the cardiologist noticed at the echocardiography a contrast image (like a 5-6 cm wire) which was floating in the right atrium.The customer also reported that no specific action was taken as the surgeons were closing up the patient's chest.The customer also reported that the image constantly appeared in the following days in subsequent echocardiographs.The customer also reported that after removal of one defibrillator lead, a fibrin socket stayed attached to the right atrium wall.On (b)(6) 2016, the customer reported that the companion 2 driver exhibited multiple alarms while supporting a patient.The customer also reported that the companion 2 driver exhibited unbalanced right and left fill volumes, with very low left flow volumes.The customer also reported that after multiple checks and tests on the driver, the medical team did a ct scan, which showed a superior vena cava thrombus and a small pulmonary embolism.The customer also reported that the suspected diagnosis was a thrombus inside the right ventricle of the tah-t because of the clinical situation and the ct scan findings.The customer also reported that the medical staff decided to start a thrombolytic treatment with a blood clot medication, actilyse, and decided against direct surgery.The customer also reported that while they discussed opening the chest to clean out the tah-t, they did not proceed with that plan.The customer also reported that the surgeon decided to switch the patient to a backup companion 2 driver, where readings returned back to normal.The customer also reported that the fibrin socket is still floating in the right atrium near the tah-t.The customer also reported that it is likely that the fibrin socket entered the tricuspid valve on (b)(6) 2016, which induced the reported event.The customer also reported that analysis of the data showed that the driver operated as intended but did show evidence of a right/left imbalance which could have resulted from the fibrin socket entering the tricuspid valve two times.The customer emailed the driver's electronic data before the driver had been returned to syncardia.Review of the electronic data revealed the driver pressures and vacuums and rate did not change during the alarm conditions.This indicates that the driver was performing as intended.The clinical data indicated that the central venous pressure (cvp) was increased during the alarm conditions corroborating the driver data showing that the inflow valve of the right ventricle was allowing retrograde flow to enter into the right atrium because of an inflow valve that was prevented from fully closing.With evidence of foreign matter in the right atrium and the fact that the driver system reported no errors and the flow measurements were accurate, there appeared to be some outside influence on the valve in the right ventricle.Further, the impingement on the valve was intermittent.When the companion 2 driver was exchanged for another driver, the filament observed in the right atrium of the patient evidently floated out of the valve and no longer impinged on the full action of the inflow valve.Thus, the exchange of the companion 2 driver for a backup companion 2 driver caused the flows to return to normal because interrupting the flow for a second or two as the drivelines were moved from one driver to the next caused the debris that had apparently floated into the valve to become free from the valve.Therefore, the valve in the right ventricle was again fully closing.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

Operator changed from patient/lay user to health professional; event type was changed from device malfunction to serious injury.The companion 2 driver was returned to syncardia for evaluation.The patient data file was reviewed and confirmed the alarms experienced by the customer.Visual inspection of the driver's external and internal components revealed no anomalies.The customer-reported issue was not reproduced during investigation testing.The driver performed as intended, and there was no evidence of a device malfunction.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).

Event Description

On (b)(6) 2016, the patient was implanted with a temporary total artificial heart (tah-t) at (b)(6).The customer reported that at the end of the tah implantation, the cardiologist noticed at the echocardiography a contrast image (like a 5-6 cm wire) which was floating in the right atrium.The customer also reported that no specific action was taken as the surgeons were closing up the patient's chest.The customer also reported that the image constantly appeared in the following days in subsequent echocardiographs.The customer also reported that after removal of one defibrillator lead, a fibrin socket stayed attached to the right atrium wall.On (b)(6) 2016, the customer reported that the companion 2 driver exhibited multiple alarms while supporting a patient.The customer also reported that the companion 2 driver exhibited unbalanced right and left fill volumes, with very low left flow volumes.The customer also reported that after multiple checks and tests on the driver, the medical team did a ct scan, which showed a superior vena cava thrombus and a small pulmonary embolism.The customer also reported that the suspected diagnosis was a thrombus inside the right ventricle of the tah-t because of the clinical situation and the ct scan findings.The customer also reported that the medical staff decided to start a thrombolytic treatment with a blood clot medication, actilyse, and decided against direct surgery.The customer also reported that while they discussed opening the chest to clean out the tah-t, they did not proceed with that plan.The customer also reported that the surgeon decided to switch the patient to a backup companion 2 driver, where readings returned back to normal.The customer also reported that the fibrin socket is still floating in the right atrium near the tah-t.The customer also reported that it is likely that the fibrin socket entered the tricuspid valve on (b)(6) 2016, which induced the reported event.The customer also reported that analysis of the data showed that the driver operated as intended but did show evidence of a right/left imbalance which could have resulted from the fibrin socket entering the tricuspid valve two times.The customer emailed the driver's electronic data before the driver had been returned to syncardia.Review of the electronic data revealed the driver pressures and vacuums and rate did not change during the alarm conditions.This indicates that the driver was performing as intended.The clinical data indicated that the central venous pressure (cvp) was increased during the alarm conditions corroborating the driver data showing that the inflow valve of the right ventricle was allowing retrograde flow to enter into the right atrium because of an inflow valve that was prevented from fully closing.With evidence of foreign matter in the right atrium and the fact that the driver system reported no errors and the flow measurements were accurate, there appeared to be some outside influence on the valve in the right ventricle.Further, the impingement on the valve was intermittent.When the companion 2 driver was exchanged for another driver, the filament observed in the right atrium of the patient evidently floated out of the valve and no longer impinged on the full action of the inflow valve.Thus, the exchange of the companion 2 driver for a backup companion 2 driver caused the flows to return to normal because interrupting the flow for a second or two as the drivelines were moved from one driver to the next caused the debris that had apparently floated into the valve to become free from the valve.Therefore, the valve in the right ventricle was again fully closing.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5534587
• MDR Text Key: 41824474
• Report Number: 3003761017-2016-00087
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR