MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE

Catalog Number 1403

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Log file analysis review date (b)(4) 2016: normal power consumption.With additional notes: 1 vad disconnect alarm was logged on (b)(4) on (b)(4) 2016 at 08:01:06; 1 vad stopped alarm was logged on (b)(4) on (b)(4) 2016 at 06:15.The instructions for use (ifu) and patient manual, and training material provide clear instructions to the user on proper usage and care of the driveline.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and device management; additional guidelines instruct the user on how to detect and react to a disconnection of the driveline from the controller.The instructions for use (ifu) and patient manual provide clear instructions to the user on proper usage and care of the hvad system.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and hvad support; additional guidelines instruct the user on how to detect and react to a 'vad stop'.A "vad stopped" alarm will activate if the pump driveline is not connected to the new controller within 10 seconds.This alarm will resolve once the pump driveline is connected.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.This is one of two reports (3007042319-2016-01569 and 3007042319-2016-01573) submitted for devices related to the same event.

Event Description

It was reported from the us that a patient was at home and reported vad stop alarm and then it "self-resolved".The patient also reported an "electrical fault alarm".The treatment team are not sure why but a controller exchange was conducted.The patient was admitted to the hospital.The device was interrogated and log files for controller that had stop alarm and the log files from new controller were sent.The driveline was inspected and found to have ultraviolet degradation as well as breaks in the sheath.A sheath repair was conducted per the manufacture procedure and breaks were found in the outer polyurethane sheath but the inner lumen colored wire insulations are not compromised.The breaks in the driveline were filled using injectable silicone and rescue tape completed by clinical engineer.No pump stops were noted during the procedure.The treatment team will not be returning the controller.No additional information is available at this time.

Manufacturer Narrative

Peripheral device is not implantable.The driveline was not returned for evaluation.Review of the manufacturing records confirmed that the device met all requirements prior to release.Log file analysis revealed a vad stopped alarm accompanied by a medium priority electrical fault alarm on the reported event date (b)(6) 2016.The alarms were most likely due to an overcurrent from wires coming into contact with each other which cause a false reading on the front stator's impedance values, leading to the electrical fault alarm.Onsite inspection of the driveline revealed damage to the driveline sheath and inner lumen.A sheath repair was performed which resolved all issues.The most likely root cause of the electrical fault and vad stopped was the driveline wires coming into contact with each other due to the damage sustained to the inner lumen.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This is two of two reports (3007042319-2016-01569 and 3007042319-2016-01573) submitted for devices related to the same event.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5568038
• MDR Text Key: 42376805
• Report Number: 3007042319-2016-01573
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 1403
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR