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

Catalog Number 1104

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2015

Event Type  malfunction  

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.It is possible that procedural factors related to the insertion of the inflow cannula through the sewing ring may have contributed to the event; however, based on the information, no conclusion can be made.The pump has been returned to the manufacturer with final analysis pending.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 that after insertion of the inflow cannula into the ventricle through the sewing ring, ensure that the pump housing is flush with the sewing ring housing and after tightening the sewing ring's screw verify no blood or air leakage around the sewing ring.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported by the hospital ventricular assist device (vad) coordinator from (b)(6) that during placement of the pump at the implant procedure, they saw blood flow through the sewing ring.The pump was removed from the sewing ring and they noticed that the o-ring had been cut during placement of the pump.It was not possible to implant this pump; therefore the pump was exchanged for another one with no reported effect on the patient.

Manufacturer Narrative

Unchecked "user facility" and checked "health professional".The o-ring was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed since the device was not returned and there is no evidence or supporting data provided.The device was related to the reported event; however there is no evidence to suggest that a device malfunction caused or contributed to the reported event.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.

• 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: 5090350
• MDR Text Key: 26248642
• Report Number: 3007042319-2015-02246
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2015
• 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