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

Catalog Number 1104

Device Problems Detachment Of Device Component (1104); Pumping Stopped (1503)

Patient Problem Loss of consciousness (2418)

Event Date 01/16/2014

Event Type  Injury  

Event Description

Approximately ten and a half months after hvad implantation, this patient's driveline became completely severed, about 4cm from the exit site, during wound care by his wife.Resuscitative efforts were performed and the patient required sedation.A temporary splice repair was performed by a regional vad coordinator at the local hospital and the pump restarted.The patient was transported to the implanting facility for further evaluation and driveline repair.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.

Manufacturer Narrative

The heartware vad is used for treatment not diagnosis.The driveline cable was not returned for evaluation as it remains implanted.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.There is no prior history of servicing done to this patient.The driveline cable was accidentally severed by the patient's spouse, after which the site attempted to perform a repair.The repair was examined on site by a heartware field engineer, and it was determined that the repair was insufficient.A splice repair was performed per procedure to mitigate the damage.Afterwards, the field engineer confirmed that the repair was functioning per specification.After reviewing the information provided, it was determined that a device malfunction did not cause or contribute to the reported event.The root cause of the reported driveline wire damage is an accidental severed driveline cable which caused a loss of connection to the controller.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) specifically states to protect the driveline from damage and warns that should the driveline become disconnected from the controller it will result in a pump stop.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.

• 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: 4085759
• MDR Text Key: 4742297
• Report Number: 3007042319-2014-00948
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2012
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention