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

Catalog Number 1102

Device Problems Decoupling (1145); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

Approximately six months and two weeks post heartware lvad implantation, the vad coordinator reported that the patient's driveline cable sheath had broken in multiple places and that the driveline connector clamp nut was not secure.The field engineer successfully performed a driveline connector and sheath repair.There was no reported patient injury as a result of this event.Investigation is ongoing.

Manufacturer Narrative

Device evaluated in the field by heartware clinical engineering personnel.The pump and driveline remain 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 hvad pump ((b)(4)) was not returned for evaluation as it remains implanted.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.The reported event was confirmed; inspection by a field service engineer revealed a loose connector clamp nut and a damaged outer sheath on the driveline.A driveline connector and driveline sheath repair was performed to mitigate and remediate the conditions reported under the event.The patient has not experienced any similar events following the driveline connector procedure.Heartware has opened an internal investigation to evaluate loose connector clamp nuts; it identified that the most likely root cause is a reduction in bonding strength of the connector assembly and increasing the gap between the front and rear connector bodies during the manufacturing assembly process, which causes a decrease in the rear connector body removal torque (force).The manufacturing assembly process order of steps for all hvad fischer connectors was modified to resolve the root cause.The most likely root cause of the outer sheath damage can be attributed to environmental factors and device maintenance of which can cause sheath degradation.There are no known clinical factors that could have contributed to this event.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) provides instructions for properly connecting the power sources.It instructs to line up the solid white arrow on the connector with the white dot on the controller.Gently push the cable into the controller.Do not twist the connector, but allow it to naturally lock in place.A successful connection will result in an audible click.The ifu cautions not to force connectors together without proper alignment.Forcing together misaligned connectors may damage the connectors.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: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 4168973
• MDR Text Key: 18926124
• Report Number: 3007042319-2014-01082
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

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: 12/31/2011
• Device Catalogue Number: 1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2010
• 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-1323-2013
• Patient Sequence Number: 1