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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)

Event Date 01/29/2018

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.(b)(4).Controller 2.0/con310849/cat# 1420/exp.Date: 2018-08-31.Udi#: (b)(4).Device available for eval: no.Mfg.Date: 2017-08-31.Evaluated by mfr: no; device not returned.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient while hospitalized had a controller with bent pins on the data port and the nurse attempted to perform a controller exchange at beside.Once the exchange was performed the pump did not restart.The cardiologist attempted a second controller exchange later and the pump did not restart.This patient had high watts at the time, for suspected thrombus.It was stated that the patient developed atrial fibrillation and stopped breathing and was coded and could not be resuscitated and then expired hours later.It was stated that the patient was also having symptoms of hemorrhagic cardiovascular accident (hcva) at time of death.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Controller was returned, and preliminary analysis indicated that the returned controller failed visual inspection and functional testing.The reported event was confirmed via controller log file analysis.Investigation is ongoing.Heartware ventricular assist system-controller.Controller 2.0/ (b)(4), received on 2018-02-23.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: date of the event.Of inital report correction.Date mfg rec: 2018-01-29-of inital report 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.

Manufacturer Narrative

Product event summary: the controller ((b)(4)) was returned for evaluation.The hvad pump ((b)(4)) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the controller in relation to the reported event.Visual inspection of the controller revealed hairline cracks around power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.An investigation was opened to investigate cracks observed on pioneer 2.0, in the area surrounding the power port connectors.Failure analysis of the controller also revealed that the serial cable or the alarm silence adapter was unable to be connected to the controller due to the damaged pins on serial port.Log file analysis revealed an increase in power consumption to parameters above the normal operating range beginning (b)(6) 2018 through (b)(6) 2018, followed by a second increase in power consumption beginning (b)(6) 2018.38 high power alarms have been logged since (b)(6) 2018.A vad disconnect alarm was logged on (b)(6) 2018 at 18:44:45 from controller (b)(4).A vad stopped alarm was logged at 18:45:39 due to a failure of the pump to restart.A controller power-up event was logged at 18:47:59.12 seconds later another vad disconnect alarm was logged.A second controller power-up event was logged at 18:50:32.8 seconds later a final vad disconnect alarm was logged.These most likely were due to the reported controller exchanges and/or an attempt at troubleshooting.As a result, the reported event was confirmed.The most likely root cause of the reported bent pins can be attributed to a misalignment between the data port and data cable connector.Manufacture has opened an investigation to investigate bent/damaged pins with controller 2.0.Based on historical review of similar high-power events, the most likely root cause of the high-power events can be attributed to external factors such as thrombus formation/ingestion.This thrombus likely got ingested into the pump, causing the pump to stop and not be able to restart.The most likely root cause of the vad disconnect alarms may be attributed to a physical disconnection of the driveline from the controller.The device remains implanted in the patient and is thus not available for return to the manufacturer with a review of the available information there is no evidence to indicate any device malfunctions or performance issues that would impact the reported events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: controller/(b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding the recall number.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
• Type of Device: VENTRICULAR (ASSISST) 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: 7251206
• MDR Text Key: 99348366
• Report Number: 3007042319-2018-00541
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1336-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 53 YR