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

Catalog Number 1103

Device Problem Cut In Material (2454)

Patient Problem Anxiety (2328)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in the patient and is thus not available for return to the manufacturer.Controller (b)(4) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.The reported event was confirmed via review of the controller log files which revealed multiple electrical fault alarms on (b)(6) 2016 of type "sys_rear_over_current_trip" that may be indicative of a short inside the driveline/driveline connector.No more electrical faults were observed after (b)(6) 2016.Furthermore, on-site inspection of the driveline cable revealed a cut on the inner lumen which aligns with the reported event.Also, a portion of the outer sheath was missing and the outer sheath appeared dark in color.Of note, electrical faults were not reproducible upon manipulation of the driveline.A driveline sheath repair was performed to mitigate the sheath damage.The most likely root cause of the reported "electrical fault alarms" can be attributed to the cut induced to the inner lumen, thus compromising the integrity of the outer sheath potentially allowing foreign material to seep in which probably caused a short inside the driveline/driveline connector triggering electrical fault alarms.Heartware has initiated an investigation which is currently evaluating events related to sheath degradation.Based on the investigation, the most likely root cause of sheath degradation may be attributed to excessive exposure to uv light.Per the instructions for use (ifu): the hvad driveline is a cable that connects to the implanted pump and passes through the skin to connect to the external lvad system components.The instructions for use (ifu) and patient manual caution the user to not pull, kink or twist the driveline or the power cables, as these may damage the driveline.Special care should be taken not to twist the driveline while sitting, getting out of bed, adjusting the controller or power sources or when using the shower bag.Users are to examine the driveline for evidence of tears, punctures or breakdown of any of the material during exit site dressing changes.The ifu and patient manual also cautions users that they should not attempt to repair or service any equipment.If service is required, they should contact their doctor, nurse or vad coordinator.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.The ifu and patient manual explain the correct method of connecting to and disconnecting from the power sources and the controller to prevent damage to either the power source connections or the controller power ports.In addition, failure to ensure a secure connection between the driveline and controller may cause an electrical fault.A fault in the continuity of the pump to controller connection could be in the pump, driveline and connector or within the controller.Failure to follow instructions on protecting the driveline connector or improper use of the driveline cap could result in contamination or damage to the connector and electrical fault alarms could occur.When this alarm condition occurs, the pump will be running on a single stator and will consume slightly more power.The ifu and patient manual caution the user to always have a backup controller available and programmed identically to the primary controller.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.(b)(4) / 1403us / manufacturing date: 10/31/2014 / expiration date: 10/31/2015.(b)(4).

Event Description

A report was received that the patient had two "electrical fault" alarms on (b)(6) 2016.Clinical engineer arrived to clinic on (b)(6) 2016.During the service evaluation, controller log files revealed electrical faults as over current trip.The patient had competitor's rescue tape on the driveline cable.The rescue tape was subsequently removed to help troubleshoot the electrical faults.A small cut was observed on the inner lumen.There were approximately 8 inches of outer sheath missing from the driveline cable.The majority of the remaining outer sheath appeared to be dark in color.The driveline cable was manipulated but electrical faults could not be reproduced.A driveline sheath repair was performed.There were no pump stops during the repair.Photos provided of the reported damage appears to confirm the event.The patient reported anxiety as a result of the event.No further patient complications have been reported.

Manufacturer Narrative

Additional information received from the clinical study database indicated that the patient was seen in the clinic on (b)(6) 2016 and was noted to have "electrical fault" and "high watt" alarms on (b)(6) 2016.The patient did not have any active alarms at that time.A portion of the driveline sheath had come off and rescue tape was applied.It was recommended that a driveline continuity test be performed and to identify whether driveline was compromised.The patient was advised to come to hospital and be monitored overnight for driveline evaluation.The patient was admitted on evening of (b)(6) 2016.The patient was stable overnight and no issues were noted.The clinical engineer performed driveline continuity test and repair on morning of (b)(6) 2016.The engineer also applied rescue tape on driveline.The patient was stable and discharged home the same day.The event was reported to have resolved on (b)(6) 2016.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Additional information received from clinical database indicated that the left ventricular assist device (lvad) parameters were available at time of onset.The primary investigator reported that the event was related to the device.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• 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: 6661356
• MDR Text Key: 78284707
• Report Number: 3007042319-2017-01981
• 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,study
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1751-2015
• Patient Sequence Number: 1
• Patient Age: 53 YR