MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP; VENTRICULAR (ASSIST) BYPASS

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problem Death (1802)

Event Date 12/21/2017

Event Type  Death  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was found down at home.Resuscitation was attempted but unsuccessful and the patient passed away in the emergency department after over an hour of advanced cardiac life support (acls).When paramedics arrived on scene the controller was not hooked up to a power source.Per the paramedics the ventricular assist device (vad) controller was unplugged and started after they connected battery to one side.There are no pump stops on the screen so it seems that the patient may have lost consciousness during power change but did not appear to have a double disconnect in log files, only alarms noted were low flows.

Manufacturer Narrative

Product event summary: the pump and controller were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Failure analysis of the returned controller revealed that the device passed functional testing.A visual inspection under 10x magnification revealed a hairline crack around power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline crack is not related to the reported event.The root cause of the hairline crack was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.The reported low flow event was confirmed through log file analysis, which revealed 100 low flow alarms logged since december 19, 2017.Log file analysis also revealed a controller power up and motor start event on december 21, 2017 at 21:50:54.The controller was without power for 13 minutes and 22 seconds.As a result, the reported power l oss event was confirmed.Based on the available information, the most likely root cause of the power loss event can be attributed to the reported disconnection of both power sources from the controller.Based on risk documentation and the available information, possible causes of the low flow event may be attributed to multiple factors including but not limited to constriction at the outflow graft, poor vad filling, and/or patient factors.Other devices involved in this event: heartware ventricular assist system ¿ controller 2.0 model 1420 serial number: (b)(4), expiration date: 2018-04-30 udi (b)(4).Device eval 2018-01-30 mfg date: 2017-04-30 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the controller was returned to the manufacturer and subsequently tested out of specification during manufacturer¿s analysis.The patient was enrolled in the endurance clinical trial.

Manufacturer Narrative

This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7154171
• MDR Text Key: 96033470
• Report Number: 3007042319-2017-05514
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2012
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2010
• 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): Death
• Patient Weight: 80