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

Catalog Number 1103

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2014

Event Type  Injury  

Event Description

Approximately one year post hvad implantation the patient was already admitted to the intensive care unit for right heart failure, when while standing up in his room he accidentally disconnected his driveline from his primary controller.He reportedly lost consciousness and had a seizure prior to being emergently reconnected to his back-up controller.Once reconnected to the back-up controller, the patient regained consciousness and stabilized.The hospital staff noted that the connector locking mechanism was not engaging; and applied rescue tape to secure the patient's driveline temporarily to the back-up controller until a repair procedure could be performed by a heartware engineer.Later that day, heartware engineers arrived at the site to restore the function of the driveline's locking mechanism.The engineers noted that the connector had difficulty switching between the locked and unlocked positions.The material interfering with the locking mechanism movement could not be identified.The engineer performed fs0004 procedure and used cleaning agents to restore the function of the locking mechanism.The patient's primary controller was returned to the manufacturer for analysis and he was provided with a new controller.Additional information received indicated that the patient is now listed for both heart and kidney transplant.Investigation is ongoing.

Manufacturer Narrative

The product remains implanted in the patient, therefore it will not be returned.Additional information will be submitted within thirty (30) days of receipt.Device remains implanted.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported that the patient was in the intensive care unit (icu) when he accidentally disconnected his driveline from his primary controller ((b)(4)) while standing up in his room.The patient lost consciousness and had a seizure.Once reconnected to the back-up controller, the patient regained consciousness and stabilized.Upon completion of a review of the controller ((b)(4)) and pump ((b)(4)), it was concluded that the units met all the internal requirements prior to its quality assurance release process.A manufacturer representative inspected the connector at the facility and noted difficulty switching between the locked and unlocked positions.A driveline repair was performed successfully allowing the connector locking mechanism to be fully functional, as confirmed by the manufacturing representative.The most likely root cause of the reported event is migration of epoxy from the connector threads to the connector sleeve due to improper technique in the assembly process.Heartware has an open internal investigation to evaluate these types of issues.A field safety notice (fsca dec2013.1) was issued to provide affected clinicians and patients with information to recognize when the locking mechanism of the driveline connector has failed to engage and actions to be taken when appropriate.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 (ifu) note specifically states to protect 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.While there is no available information at this time to indicate the cause of this reported event, it may be possible that foreign material was introduced into the driveline connector during the implant procedure.Heartware is submitting this report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.This is one of two reports (3007042319-2014-00430 and 3007042319-2015-03815) submitted for devices related to the same event.

• 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: 3802912
• MDR Text Key: 4382102
• Report Number: 3007042319-2014-00430
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2013
• 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-1131-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention