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

Catalog Number 1103

Device Problems Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2014

Event Type  Injury  

Event Description

Approximately one month post hvad implantation the patient noted a high priority alarm and the wife performed an emergent controller exchange to the patient's back-up controller.While on the phone with the vad coordinator, the wife reported that the new controller was having electrical fault alarms and a vad stop alarm.The wife was instructed to switch the patient back to his primary controller and the pump restarted.He remained asymptomatic during the exchanges.He was subsequently transported to the hospital where the clinical specialist inspected his driveline.There was no obvious evidence of wire fracture and alarms were not reproducible with manipulation of the driveline connector.A sticky, reddish, discolored area was noted on the driveline's boot and on the metal portion of the driveline connector itself that according to the patient was spray paint.The locking mechanism appeared to be stuck in the unlocked position and was difficult to move back and forth so a splint was placed to secure the driveline connection until a heartware engineer could inspect.The next morning a heartware engineer arrived on site.Paint residue was removed from the outside of the connector and a driveline connector repair was performed per procedure.The driveline was disconnected for inspection and pins appeared clear of any residue.The patient tolerated it well.Several hours later the vad coordinator reported that the patient experienced another vad stopped alarm and subsequently performed a controller exchange from the patient's primary controller to a new controller.This exchange took approximately three minutes during which the patient was reportedly clammy and diaphoretic.The heartware engineer returned to the site to perform a more thorough driveline cleaning; however, the site wanted the procedure to be performed in the operating room for precautionary measures but no surgeons were available that night.The patient was transferred to a nearby hospital where a surgeon was available to observe the patient.The next afternoon he returned to his implanting facility to have the cleaning procedure performed in the operating room.The heartware engineer conducted the cleaning procedure and connected the patient to a new controller without incident.This event is believed by the treating physician to be possibly related to the device but may also be attributed to the spray paint used by the patient.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.This is one of two reports (3007042319-2014-00696 and 3007042319-2014-00697) submitted for devices related to the same event.Evaluation in progress.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported that patient experienced a 'vad stop' alarm resulting in an emergent controller exchange by the patient's caregiver.The patient then experienced 'electrical fault' alarms and a 'vad stop' alarm.The patient's caregiver exchanged the controller back to the original controller and went to the site for further evaluation.Upon evaluation by the manufacturer's representative, the patient had multiple areas on the driveline boot covered in paint along with the controller pack.The driveline connector sleeve was difficult to move from the unlocked to locked position.Manipulation of the driveline did not produce any alarms.A driveline connector locking mechanism repair was performed per the manufacturer's specifications.The driveline was also disconnected revealing no residue evident on the driveline connector pins.The patient presented an additional 'vad stop' alarm after original assessment; the site performed a controller exchange.Upon reassessment, the manufacturer representative performed a cleaning procedure to ensure that there was no spray paint residue in the female pins of the connector.The patient was stable during the procedure.The controllers ((b)(4)) were returned to manufacturer for evaluation.The controllers passed visual and functional testing; the reported event could not be reproduced.However, log file analysis revealed the reported 'vad stop' and 'electrical fault' alarms.Based on the evaluation performed by the manufacturer representative, the most probable root cause for the reported "electrical fault alarms" and "vad disconnect" alarms may be associated with a partial connection between the driveline connector and controller as a result of spray paint residue evident on the patient's peripherals.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 outlines required surgical steps to prevent driveline contamination during tunneling.It additionally warns that 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.It further outlines to verify that the connector is dry and clean before attaching to the controller.The instructions for use and patient manual also include a reference guide for alarms including potential causes and actions to take.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.This is one of three reports (3007042319-2014-00696, 3007042319-2014-00697 and 3007042319-2015-002790) 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: 3924349
• MDR Text Key: 4492790
• Report Number: 3007042319-2014-00697
• 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: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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
• Treatment: (B)(4)_CONTROLLER; (B)(4)_CONTROLLER
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 86