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

Catalog Number 1125

Device Problems Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problem Blood Loss (2597)

Event Date 05/15/2014

Event Type  Injury  

Event Description

Excessive bleeding from the vad outflow graft was noted during the hvad implant procedure, when the patient was being weaned from cardio-pulmonary bypass (cpb).Bleeding was noted from the outflow graft.Upon inspection, a slit in the outflow graft was seen under the pump strain relief.The site reported no unusual difficulties in attaching the outflow graft and strain relief to the vad outflow cannula and the graft was dry when it was attached.The clamp had required some hand tightening.The vad was stopped and the patient returned to cpb.The strain relief and the outflow graft were removed from the pump and the graft cut to remove the affected portion.The unaffected portion of the outflow graft and the strain relief were re-attached to the pump.The vad was re-started and the patient was successfully weaned from cpb.No further bleeding was seen from the outflow graft.A picture of the outflow graft was taken and it appears that a visible slit is aligned to where the clamp would have been tightened.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.The site reported that during an lvad implantation it was noted that there was excessive bleeding emanating from the outflow graft.The patient remained under cardio-pulmonary bypass as the surgeon removed the cut/torn section of the graft and reattached the remaining portion of the outflow graft back on to the pump.There was no reported patient injury as a result of this event.The outflow graft was not returned as it remained implanted; however the site did provide the manufacturer with pictures for reference.Evaluation of the pictures received showed a longitudinal tear on the outflow graft proximal to the pump, potentially indicative of an over tightened strain relief clamp.The pictures corroborated the site's account that the strain relief clamp would not close and was therefore potentially over tightened.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 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 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 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: 3867184
• MDR Text Key: 4570210
• Report Number: 3007042319-2014-00602
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2014
• 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