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

Catalog Number 1104

Device Problems Detachment Of Device Component (1104); Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/16/2014

Event Type  Death  

Event Description

Approximately two years after hvad implantation the patient was found non-responsive with his driveline disconnected.Controller showed no visible signs of damage and power was connected to both sides.Preliminary post mortem noted small focus discoloration in the right posterior inferior cerebellum and a slight bump on patients head.Doctor does not believe device is related to the precipitating event.He noted it is likely that the patient fainted or fell which led to driveline becoming caught and dislodged.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.Device remains implanted.

Manufacturer Narrative

The hvad is used for treatment not diagnosis.It was reported from (b)(6) that the patient was found non-responsive on (b)(6), 2014 with his driveline disconnected.Device testing could not be performed as the pump and driveline were not returned for evaluation.However, a review of the controller log files revealed 'driveline disconnect' alarms confirming the reported event.Log files indicate no abnormal pump operation prior to the driveline disconnect; the controller remained powered by both batteries.Review of the manufacturing documentation confirmed that the devices met all requirements for release.The post-mortem examination revealed that the patient experienced head trauma which was likely the result of the patient collapsing.The site indicated that the patient had recently experienced neurological dysfunction (hcva) which may have been a contributory factor to this event.While the cause of the driveline disconnection cannot be conclusively determined, available information indicates that the hvad system functioned as intended.There is no indication that a device malfunction caused or contributed to the reported event.The possible root cause of the patient death may have resulted from a pump stop due to the physical disconnection of the driveline cable from 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.Death is a known potential clinical adverse event associated with vads as outlined in the ifu.Investigations of complaints with similar circumstances were reviewed; events related to death are multifactorial and may be attributed to failed modality, medical treatment, progression of disease, and patient comorbidities.Heartware will submit a supplemental report when new facts arises which materially alters 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 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 4098319
• MDR Text Key: 4696649
• Report Number: 3007042319-2014-00958
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• 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
• Treatment: CLOPIDOGREL
• Patient Outcome(s): Death
• Patient Age: 64 YR