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

Catalog Number 1103

Device Problems Detachment Of Device Component (1104); Connection Problem (2900)

Patient Problem Death (1802)

Event Date 11/13/2014

Event Type  Death  

Event Description

Approximately two and a half years post implantation, the patient was found at about 5am deceased on the floor of his home.The controller was on the ground at the patient's feet in its bag (with no strap) with two batteries attached; however, the driveline was not attached to the controller.Emergency medical service was called and there were several attempts to reconnect the driveline with continued alarms.The log files revealed that the vad was disconnected at 2:19 am.It was reported that an autopsy would be performed.

Manufacturer Narrative

An autopsy is to be performed with report that driveline and controller to be returned after facility internal inspection.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.The reported event indicates that the patient was found deceased with his driveline cable disconnected from the controller.The controller and driveline cable were returned to the manufacturer for evaluation.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Evaluation of the controller revealed that it passed visual and functional testing.Thorough external visual inspection of the controller revealed no signs of physical damage or contamination and functional testing did not indicate any abnormal operation of the controller.Review of the controller log files confirmed the reported event which revealed "low flow', "electrical fault', "high watt', "vad stopped', and multiple "vad disconnected' alarms correlating to the reported event.Furthermore, the log file analysis indicates that there was an intermittent connection between the pump and the controller wherein the pump was not able to successfully restart.Analysis of the transected driveline from the incident device revealed that the fischer connector was observed to have recessed pins.A review of the log files supports this as a likely cause of the vad stopped and low flow alarms.Given the recessed pins (and the missing swaged ring), it is likely that the driveline experienced a pull possibly from a drop as the controller was found at the patients feet.Details reported in several complaints, which occurred in close proximity to this event, revealed two other events in which the patient's driveline cable disconnected from the controller; one of those events was the reported to have resulted from the patient dropping the controller.Applicable risk documentation and experience with events of similar circumstances were considered; events with an intermittent electrical connection of the driveline are most often attributed to a tensile force on the driveline connector and result in partial loss of electrical continuity.Given that at the time of the complaint the pump was manufactured with the rtv process and the fact that there is evidence that the patient dropped the controller contrary to ifu recommendations, the most probable root cause of the reported event can be attributed to driveline design deficiency as well as user error.The manufacturer has initiated an internal investigation to evaluate this type of malfunction.In may 2015, a field safety notice (fsca apr2015b) was issued to clinicians to be delivered by sites to patients that have previously had splice repair.It will provide awareness, warnings, and safety mitigations regarding failure of the splice connector assembly.As a corrective action, heartware will re-splice affected patients with epoxy in connector (informed decision by physician and patient).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, including transportation.The instructions for use and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damages.It is outlined to inspect the power connections and pins once a week, one at a time when changing the power source.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time with a warning to switch to the back-up controller if there is a controller failure the steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.Heartware is submitting this report as a result of remediation activities related to fda warning letter (b)(4), dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

• 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: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 4266553
• MDR Text Key: 5229854
• Report Number: 3007042319-2014-01231
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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-1604-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death