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

Catalog Number 1104

Device Problems Pumping Stopped (1503); Cut In Material (2454)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

Four days post hvad implantation the patient reportedly cut into his driveline cable with a nail clipper after experiencing drug-induced psychosis following the administration of thc drops to increase his appetite.The patient cut the driveline in two different locations resulting in a pump stop and multiple electrical fault alarms and an increase in pump power from 4.5 to 6 watts.The pump restarted on the rear stator but continued to have electrical faults.Heartware engineers arrived on-site the same day for driveline inspection and the patient was taken to the operating room for a splice repair.The patient tolerated the procedure without incident.

Manufacturer Narrative

Additional information will be submitted within thirty (30) days of receipt.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported that this patient experienced electrical fault and high watt alarms after cutting the driveline cable in two different locations at which the yellow and blue wires were severed.Upon evaluation by the manufacturer's representative, a small incision about twenty (20) cm away from the exit wound, damage to the outer sheath and inner lumen, and damage on the blue and yellow wire was found.A driveline splice repair procedure was performed to repair the driveline cable by a manufacturer representative.The patient tolerated the pump off time well.The pump was running on a single stator the whole time after the event and before the splice repair; however, once the driveline splice repair was performed, the pump restarted.The reported event was confirmed via review of the controller log files, which revealed multiple electrical fault alarm, vad disconnect alarms and one high watt alarm.The most probable root cause of the reported event may be attributed to the patient cutting the driveline cable in two different locations, damaging the driveline wires.A clinical factor that may have contributed to this event is the fact that this patient was given tetrahydrocannabinol (thc) drops to increase appetite by the medical staff but afterwards, the patient had a paradox reaction with hallucinations.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 heartware hvad instructions for use advises that the driveline cover should completely cover the controller's silver driveline connector to protect it and keep it clean.The ifu instructs, "do not disconnect the driveline or power sources from the controller while cleaning it or the pump will stop.If this happens, reconnect the driveline to the controller as soon as possible to restart the pump.The instructions for use (ifu) specifically states to protect the driveline from damage and warns that should the driveline become disconnected from the controller it will result in a pump stop.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.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: 3897430
• MDR Text Key: 17259232
• Report Number: 3007042319-2014-00656
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization