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

Model Number 397002-001

Device Problems Sticking (1597); Audible Prompt/Feedback Problem (4020)

Patient Problems Stroke/CVA (1770); Death (1802); Encephalopathy (1833); Renal Failure (2041); Right Ventricular Failure (2055)

Event Date 03/21/2018

Event Type  Death  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.Syncardia systems, llc 70 cc temporary total artificial heart (tah-t) instructions for use with the companion 2 driver system, chapter 4 warnings, 4.6 states: do not allow any catheter to get near the inflow valves of the tah-t.If a catheter migrates into an inflow valve, the valve could become stuck, limiting flow.Confirm the position of the catheter by x-ray after catheter insertion and repeat an x-ray immediately if any unexplained sudden drop in cardiac output occurs.A percutaneously inserted central catheter may migrate into the inflow valve when the patient raises his or her arm.(b)(4) initial (2 of 2).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and is reported under two separate medical device reports: (1) 70 cc tah-t l/n 108279 (mfr report # 3003761017-2018-00107) and (2) companion 2 driver s/n (b)(4) (this mfr report).The customer, a syncardia certified hospital, reported that on (b)(6) 2018 the patient was taken to interventional radiology for a new iv placement via the right internal jugular vein.During the procedure, the guide wire was reported by the customer to have entered the right atrium and then became stuck in the valve of the tah-t right ventricle.The customer also reported that they have a picture of the wire stuck in the valve and that the radiologist confirmed that the guidewire was withdrawn with force to free it from the valve.It was also reported that the wire appeared to have been completely withdrawn and was not believed to be broken in any way upon removal.The customer also reported that for the undetermined amount of time that the valve was stuck, the companion 2 driver supporting the patient exhibited very low fill volumes and cardiac output alarms.The customer also reported that after approximately 50 minutes, the companion 2 driver was exchanged and the low fill volumes and associated hypotension resolved.The customer also reported that, prior to the capture of the guidewire in the right ventricle, the patient was stable but acidotic, receiving bicarbonate and vasopressors to maintain blood pressure and his end organs were not doing well.He was on continuous hemofiltration for renal dysfunction.The customer also reported that on (b)(6) 2018 the patient's neurologic status was assessed with eeg and it was determined that there was no neurologic function.Care was withdrawn from the patient on (b)(6) 2018.The customer also reported that they plotted graphs of the patient data file from the companion 2 driver as well as performed a system checkout on the companion 2 driver and indicated that the companion 2 driver appeared to function as intended.

Manufacturer Narrative

The companion 2 driver was not returned to syncardia for evaluation.The hospital performed a system check and the driver passed all testing requirements.The hospital also stated that that the driver performed as intended during the reported issue.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.Ce 4233 follow-up report 1.

• 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
• MDR Report Key: 7434463
• MDR Text Key: 105662734
• Report Number: 3003761017-2018-00120
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR