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

Catalog Number 1101

Device Problems Material Discolored (1170); Kinked (1339); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

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.The driveline remains implanted.The instructions for use (ifu) provides driveline care instructions to the clinician for inspecting the driveline for damage to the polyurethane outer tubing (outer sheath).The ifu and patient manual provide general care instructions on cleaning of the driveline, preventing damage to the polyurethane outer tubing (outer sheath).Prevention of damage and inspection of driveline information is also covered during patient and medical personnel training.Driveline cable (b)(4) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated driveline cable met all requirements for release.Log file analysis revealed no alarms and normal pump parameters recorded for the fourteen (14) days leading up to the reported event.On-site inspection of the driveline cable revealed damage to the driveline strain relief as well as yellowing and cracking of the driveline outer sheath, thus confirming the reported event.A driveline strain relief and driveline sheath repair were performed to mitigate the conditions reported.Based on the investigation conducted, the most likely root cause of the driveline sheath damage is exposure to uv light.The most likely root cause of the strain relief damage is excessive flexing of the driveline near the strain relief.Heartware has opened an internal investigation to evaluate driveline sheath damages.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 that the patient came into clinic for a routine visit and it was noted under the old rescue tape, the strain relief at the controller end of the driveline was not existent and the internal wires were exposed.The driveline was severely kinked and starting to break at the connector.It is unclear how the damage occurred but it is believed to be general wear from more than six (6) years on device.All of the silicone of the driveline had broken away from the connector, leaving only the wires holding the connection together.The patient was admitted so that clinical engineering could come in to repair.The strain relief repair and driveline sheath repair were performed.The patient was not prepped for the procedure.No pump stops occurred during the repair, a splice repair was not required and wire damage was not observed.There was no impact to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6330362
• MDR Text Key: 67418571
• Report Number: 3007042319-2017-00437
• 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
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 1101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 6 YR
• Event Location: Home
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• 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 Age: 70 YR