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 Code Available (3191)

Event Date 11/22/2013

Event Type  Injury  

Manufacturer Narrative

The hvad pump (b)(4) was not returned for analysis as it remains implanted in the patient.The controller was not returned for evaluation.Review of the manufacturing documentation confirmed that pump (b)(4) met all requirements for release.Analysis of the controller log files revealed multiple "vad stopped/vad disconnect" alarms and "electrical fault" alarms corresponding to the reported event.The root cause of the disconnection is that the patient dropped the controller, and the tensile force caused the pins to be disconnected from the contact block, causing the pump to stop.A driveline repair was performed in order to mitigate and remediate the conditions reported under the event.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Incidentally, visual examination found that the driveline connector nut on the controller was loose.Internal investigation found that the most likely root cause of the loose nut is inadequate thread locking allowing the nut to break free from its installed position.It is likely that the trauma experienced during the fall contributed to the loosening of the connector nut.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.Patient manual ifu00200 revision 07 provides an instruction and also a caution note: do not pull, twist or kink the driveline or power cables, especially while sitting, getting out of bed, adjusting controller or power sources, or when using the shower bag.It also cautions, "keep extra driveline length tucked under clothing or secured with an abdominal binder or dressing.Do not let any portion of driveline hang freely where it might get caught on external items such as doorknobs or the corners of furniture.Heartware is submitting this correction to a previously submitted mdr 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.(b)(4).

Event Description

Approximately two years and two weeks post implantation the patient presented to the emergency room with electrical fault and vad stop alarms.He reported that he had accidentally dropped his controller.The patient had been trained on proper use of the patient pack, although it was unclear as to whether or not he was using the pack at the time.Upon visual inspection, the vad coordinator noted damage to the connection of the controller and the driveline cable pin.They were unable to successfully reconnect the driveline cable to the controller to restart the pump.The patient was placed on a dobutamine and heparin drip for symptoms related to hypotension and to prevent clot formation.Blood pressure remained stable with inotropic support.Later that evening the engineering team performed a driveline splice repair, as the patient was not a candidate for pump exchange.They were able to successfully restart the pump after the splice repair.Details regarding follow up labs and diagnostic results were not provided.It was reported that the patient tolerated the procedure quite well and that vital signs remained steady, and the patient was doing well after the procedure.After the repair, the patient's controller was exchanged.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6081645
• MDR Text Key: 59285510
• Report Number: 3007042319-2016-03915
• 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,study
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2013
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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
• Treatment: (B)(4)_CONTROLLER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention