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

Model Number 397002-001

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problems Renal Failure (2041); Right Ventricular Failure (2055); Heart Failure (2206); No Code Available (3191)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia authorized distributor, reported that patient developed over the last weeks symptoms of severe right heart insufficiency (renal failure, liver congestion, dilated vena cava, ascitis).The customer also reported that the ct scan was not able to show any extrinsic compression or internal thrombus which could cause the right heart failure.The customer also reported that hospital staff increased the right vacuum on the companion 2 driver and improved drastically the right filling volume.The customer also reported that the patient is in the post icu, has been extubated for weeks, eats normally and takes a few steps.The customer also reported that the patient was subsequently switched to a backup companion 2 driver with no reported patient impact.

Manufacturer Narrative

Corrected data - outcomes attributed to adverse event corrected based on follow-up information received from customer.The companion 2 driver was returned to syncardia for evaluation.The patient data file was reviewed and revealed an increase in right fill volume when the vacuum was increased, and a reduction when vacuum decreased, correlating with the customer report of fill volumes increasing when vacuum was increased.There was no observed drastic increase in fill volumes from the driver's recorded data, but an overall decrease in fill volume over time was observed.The patient file data prior to and after the parameter adjustments were plotted to replicate the pressure and flow waveforms as would have been displayed on the companion 2 driver prior to and after the driver adjustments were made.A small timing delay (~10ms) between the left and right pressure waveforms was observed, which remained the same before and after vacuum adjustments and was within operating range.During incoming inspection and functional testing the driver performed as intended and there was no evidence of a device malfunction at the time of the customer reported experience.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

The customer, a syncardia authorized distributor, reported that patient developed over the last weeks symptoms of severe right heart insufficiency (renal failure, liver congestion, dilated vena cava, ascitis).The customer also reported that the ct scan was not able to show any extrinsic compression or internal thrombus which could cause the right heart failure.The customer also reported that hospital staff increased the right vacuum on the companion 2 driver and improved drastically the right filling volume.The customer also reported that the patient is in the post icu, has been extubated for weeks, eats normally and takes a few steps.The customer also reported that the patient was subsequently switched to a backup companion 2 driver with no reported patient impact.The customer also reported that approximately 6 weeks after the reported event, the patient continues a slight right heart insufficiency (minor ascitis, oliguria) and his clinical status is "quite acceptable" (post-icu, walking around).The patient slowly recovers from his renal dysfunction and does not need to be dialysed as frequently as before, as he has now some spontaneous diuresis.

• 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7061803
• MDR Text Key: 93042600
• Report Number: 3003761017-2017-00212
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR