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

Catalog Number 1125

Device Problem Cut In Material (2454)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 03/28/2014

Event Type  Injury  

Manufacturer Narrative

The heartware ventricular assist device (vad) is used for treatment not diagnosis.The site reported that during an lvad implantation it was noted that there was severe bleeding at the apex.The surgeon eventually located the source of the bleeding, a small whole in the outflow graft below the 2nd bracket of the strain relief, at the point of connection to the pump.The patient was placed back on bypass, the pump was removed, and the outflow graft and strain relief was removed and replaced with a portion of the outflow graft that had been previously cut after measuring for original anastamosis.The pump was reinserted and restarted without incident.The patient was stable while on the way to the icu.A possible root cause for the reported event could be as a result of over-tightening the clamp during the lvad implant procedure.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 heartware system instructions for use (ifu) and training material provide clear instructions on the correct outflow graft placement to avoid kinking or rupture.Moreover, the ifu provides instruction to further educate the user about product safety, alarm management, and anticoagulation recommendations; additional guidelines instruct the both the user and medical personnel on how to detect and react to a suspected thrombus formation.Heartware is submitting this correction to a previously submitted mdr 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.(b)(4).

Event Description

It was reported from the united states that during ventricular assist device (vad) implantation, severe bleeding was noted to be coming from the left ventricular apex.Packing was placed at the apex and left in place for approximately 20 minutes.When the packing was removed it was noted that the bleeding remained substantial.During this time the patient had received numerous blood products including packed red blood cells, fresh frozen plasma, and platelets.After further inspection, the surgeon believed the bleeding was coming from the outflow graft.Since the outflow graft was not easily visualized, the surgeon decided to make a thoracotomy incision to better view the suspected area.Blood was found to be oozing from a small hole in the outflow graft below the 2nd bracket of the strain relief near to where it connects to the pump outflow.The surgeon attempted to repair the cut in the outflow graft with suture but bleeding continued.The patient was returned to cardiopulmonary bypass (cpb).The pump was removed from the left ventricle apex and the outflow graft and strain relief were disassembled.The damaged outflow graft was replaced with an unused portion of the outflow graft that had been trimmed off from the original.The vad was reinserted and restarted without incident.The patient was stable in the intensive care unit (icu) post-implant.

• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6087119
• MDR Text Key: 59409100
• Report Number: 3007042319-2016-03923
• 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
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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