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

Catalog Number 1104

Device Problem Cut In Material (2454)

Patient Problem No Code Available (3191)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

The (b)(4) was not returned to heartware for evaluation, as the pump and driveline remain implanted.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of controller log files revealed 3 electrical fault alarms, 1 vad stopped alarm, 1 vad disconnect alarm and 1 high watt alarm; thus confirming the reported event.Given the electrical fault alarms, vad stopped alarm, and vad disconnect alarm logged, this may be indicative of compromised driveline inner lumen wires, an overcurrent condition due to an electrical short in the driveline or driveline connector, or an intermittent connection between the pump and the controller driveline port.Data log file showed the pump was running on rear stator only per the last available data entry.On-site inspection confirmed the damage induced to the driveline cable.A driveline splice repair was performed to mitigate the conditions reported.With a review of the available information there is no evidence to indicate any device malfunctions or performance issues that would impact the reported event.The most likely root cause of the driveline damage and subsequent alarms was the accidental cut induced by the patient as mentioned in the event details.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 hvad driveline is a cable that connects to the implanted pump and passes through the skin to connect to the external lvad system components.The instructions for use (ifu) provides an instruction and also a caution note about regular inspections of the driveline, specifically stating: "when changing your exit site dressing, inspect the driveline for moisture, cracks, and tears or punctures.Report any damage to your doctor, nurse or vad coordinator." 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 will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.(b)(4).

Event Description

It was reported by the vad coordinator that the patient accidentally cut his driveline with a knife while preparing and eating fruit.The patient reported electrical fault alarm with high watts.Review of log files showed that the pump was running on a single stator.Pictures and log files revealed that the front phase c was damaged with possible damage to the front phase b and rear phase c.The driveline splice repair was performed per procedure in the outpatient setting.The pump was stopped for a total of five minutes.The pump did not restart following repair of the front motor.The pump started successfully after completing the splice repair of the rear motor.The patient is reportedly doing fine.Additional information was provided on 9/15/2016 indicating that no medication was provided in preparation for the splice repair.The patient was discharged on (b)(6) 2016 on "patient's own risk".No further information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 5967486
• MDR Text Key: 55315334
• Report Number: 3007042319-2016-03269
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention