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

Catalog Number 1103

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2014

Event Type  malfunction  

Event Description

Almost one year post hvad implantation the patient dropped her controller and experienced electrical fault, high watts and vad stopped alarms.She presented to hospital.Staff stated that the driveline appeared to be connected to the controller, nevertheless, they attempted to push the driveline connector further into the controller and the alarms resolved.The patient was admitted and received a milrinone infusion in case the alarms returned.A heartware clinical engineer went to the site to evaluate the problem.Manipulation of the driveline did not reproduce any alarms.The patient was heparinized and the driveline disconnected so that it and the controller connector could be inspected.Everything appeared normal and the pump restarted.No further intervention was required and there were no further alarms.The patient remained stable throughout all events.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.Product remains implanted.

Manufacturer Narrative

The heartware vad is used for treatment not diagnosis.The driveline remains implanted and the controller was not exchanged; therefore these devices were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Thorough external visual inspection of the devices revealed no signs of physical damage or contamination.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.On-site inspection of the driveline did not reveal any damage to the connector pins; pump restarted successfully after reconnection of the driveline and the issue was resolved.The reported event was confirmed via review of the controller log files, which revealed multiple "electrical fault" alarms and "vad stopped" alarms indicating that the driveline was disconnected on the date of the reported event.Based on the information provided, it is possible that the patient's controller fell which induced a strong pull on the driveline cable that resulted in an intermittent electrical connection and subsequent "electrical fault" alarms recorded in the log files.No device defect or malfunction could be identified.The most likely root cause is a poor mechanical connection between the driveline and 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.The most likely root cause is a poor mechanical connection between the driveline and 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.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.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 fla-14-14, 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 310
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer Contact: kathleen jacobson ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641562
• MDR Report Key: 3800378
• MDR Text Key: 4384617
• Report Number: 3007042319-2014-00428
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2013
• 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