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

Catalog Number 1125

Device Problem Device Issue (2379)

Patient Problem Thrombus (2101)

Event Date 11/08/2015

Event Type  Injury  

Manufacturer Narrative

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 system is designed to assist a weakened, poorly functioning left ventricle.The implantation of a vad is an invasive procedure requiring general anesthesia, median sternotomy, a ventilator and cardiopulmonary bypass.These surgical procedures are associated with numerous risks.This is report one of two reports (3007042319-2016-01717, and 01718) submitted for devices related to the same event.A supplemental report will be submitted when the manufacturer's investigation has been completed.

Event Description

It was reported that the procedure done on ecmo and not cpb, however, act found to be very low after pump seated in sewing ring and clot seen in the outflow graft so original pump & & graft inserted.The pump & graft were removed by and disposed of at the site.The patient tolerated the pump exchange well and went home in the normal amount of post op.

Manufacturer Narrative

The outflow graft lot # 1001896185 was not returned to heartware for evaluation.This complaint is associated with a clinical adverse event.Review of the manufacturing documentations confirmed that the associated device met all requirements for release.Site noted a "clot" in the outflow graft, thus visually confirming thrombus in the outflow graft.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This is report two of two reports (3007042319-2016-01717 and 3007042319-2016-01718) submitted for devices related to the same event.

Manufacturer Narrative

The root cause of the reported event cannot be conclusively determined; though, clinical factors that may have contributed include the patient's previous medical history, anticoagulant therapy and related comorbidities.There are patient, procedural and pharmacological factors that may have contributed to this event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This is report two of two reports (3007042319-2016-01717 and 3007042319-2016-01718) submitted for devices related to the same event.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60 avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5593913
• MDR Text Key: 43197497
• Report Number: 3007042319-2016-01718
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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
• Patient Age: 61 YR