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 Cardiopulmonary Arrest (1765)

Event Date 01/15/2014

Event Type  Injury  

Event Description

Approximately three years and one and half months post implantation the patient's wife stated that the patient disconnected himself from his a/c power and added a battery as his second power source.He returned to bed with both batteries connected.About an hour later, the patient's wife reported a high priority alarm.The controller had fallen off the bed causing it to become disconnected from the driveline.The wife stated that reconnection of the original controller ((b)(4)) was difficult due to separation of the rear portion of the driveline connector and absence of the silicone static guard (driveline cover).She reported that a period of about five to ten minutes had passed during which the patient eventually became unresponsive with posturing.Preliminary review of the controller log data indicates that the patient was disconnected for a period of up to fifteen minutes.The wife elected to switch to his backup controller ((b)(4)).Upon completion of the emergent controller exchange the patient was reported to have resumed spontaneous respirations, but continued to have respiratory difficulty.He was transported to a neighboring hospital for treatment.At the time of his arrival, he had a blood pressure of 82/59, respirations 20 and heart rate of 79 bpm.The patient was intubated due to continued respiratory distress.A ct of the head found no evidence of acute intracranial hemorrhage.Soon after, he was transferred by survival flight to his implanting facility for continuity of care while remaining sedated and intubated.His vital signs upon arrival remained unchanged.Information received by the clinical specialist also confirms that the patient's driveline was never secured upon his arrival to the implanting facility.The day after the event, nursing staff reported that the patient became disconnected from his driveline again for approximately two minutes; however, log file analysis indicates that the pump was stopped for a period of about eighteen minutes, accompanied by electrical fault and vad stopped alarms.The nurse reconnected the patient to his previous controller ((b)(4)) and secured the driveline by placing rescue tape around the driveline connection until a repair could be completed by heartware personnel.The following day heartware engineers arrived at the site to perform the driveline connector repair following the mp00306 rev 02 procedure per fsca jan 2013 without incident.The patient was provided a new back-up controller ((b)(4)) and controller ((b)(4)) was returned to the manufacturer for analysis.Six days after being admitted the patient was discharged home in stable condition.Investigation is on-going.

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 pump was not was returned for evaluation as it remained implanted; a field servicing was performed to mitigate the reported event.Analysis of the device revealed that the device failed to meet specifications.The reported event was confirmed via visual inspection, which revealed that the rear portion of driveline connector was loosened.The confirmed malfunction is related to the reported event.Heartware has opened an internal investigation to evaluate these types of issues; 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.There are no known clinical factors that could have contributed to this event.Fsca jan2013/ z-1323-2013 was distributed as a notification to sites to inspect rear portion of the hvad® pump's driveline connector housing, in case it became partially separated or fully separated from the front portion of the driveline connector.Patient is now stable.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).This device is used for treatment not diagnosis.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 heartware® 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, "do not 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: miguel sosa ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641555
• MDR Report Key: 3628481
• MDR Text Key: 16087303
• Report Number: 3007042319-2014-00111
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/17/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2010
• 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
• Treatment: (B)(4) - CONTROLLER; (B)(4) - CONTROLLER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR