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

Catalog Number 1103

Device Problem Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Date 02/13/2014

Event Type  Injury  

Manufacturer Narrative

The hvad is used for treatment not diagnosis.The pump (hw20412) was returned to the manufacturer for analysis.The o-ring was damaged during insertion and facility prepared a completely new system.Patient remained in the icu until recovery.Review of the manufacturing documentation confirmed that the pump met all requirements for release.The device was returned to the manufacturer for evaluation.Visual inspection showed that there may have been damage during installation procedure since there was evidence of cuts, scrapes, and some peeling on the surface of the o-ring.Based on open internal investigation, the most probable root cause for the o-ring damage may be attributed to user error during implant and variation in the sewing ring gap leading to difficulty when inserting the o-ring into the sewing ring.The manufacturer has an open investigation for these types of issues.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Implantation of a ventricular assist device (vad) is an invasive procedure requiring general anesthesia, a median sternotomy, a ventilator and cardiopulmonary bypass.These surgical procedures are associated with numerous risks.All vad patients face risks including, but not limited to perioperative bleeding as outlined in the instructions for use (ifu).The ifu outlines the surgical procedure for attaching the sewing ring to the myocardium.It outlines to position the sewing ring to permit access to its screw after cannulation and ensure that the pump housing is flush with the sewing ring housing.It outlines to tighten sewing ring's screw around the pump inflow conduit using the wrench to tighten the screw until an audible "click" is heard and after tightening the sewing ring's screw verify no blood or air leakage around the sewing ring.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.

Event Description

It was reported from sweden that during a minimally invasive implantation "the pump did not connect very well" during the surgery.The implant procedure was done as a thoracotomy with mini-sternotomy.After placing the pump, it was noticed that there was a very small gap in the metal with significant blood loss.At first, the implanting surgeon thought that the sewing ring was loose and tried to fix it with felt pledgets.This was not successful so the pump was removed and the sewing ring replaced.Once the sewing ring was removed they noticed that the silicon ring on the pump was broken.The procedure was extended by approximately 180 minutes while the facility unpacked and prepared a completely new system.The patient was maintained on cardiopulmonary bypass and the blood lost was collected and given back to the patient.It was stated that it may have been possible that the silicon ring was damaged during implant due to manipulation and the fact that they were not aware that the screw in the ring should have been removed prior to insertion of the pump.The patient required an approximately three (3) week stay in the intensive care unit to recover after implantation.

• 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: 5204007
• MDR Text Key: 30469025
• Report Number: 3007042319-2015-02768
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention