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

Model Number 1103

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/04/2018

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 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 during the ventricular assist device (vad) implant procedure there was a pump malfunction.Persistent electrical fault alarms presented after connecting the driveline to the controller.Both the controller and power sources were swapped out to troubleshoot but electrical fault alarms persisted.The vad was exchanged and no further electrical fault alarms were noted.This occurred even after a successful wet test in the operating room.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the pump with the driveline cable was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported electrical fault alarms were confirmed via available log file report which revealed 3 electrical fault alarms on (b)(6), 2018; however the cause of the alarms could not be verified since the log files were not provided for analysis.Failure analysis of the returned pump revealed that the device passed visual examination and dimensional verification.Functional analysis of the pump was not possible since the driveline was too short to be able to splice the driveline and then conduct a functional testing.Internal pathological report revealed no evidence of thrombus within the device.Additionally, visual examination of the driveline did not reveal any damage to the outer sheath/ wires, recessed pins, and/or foreign material inside the connectors that may have compromised the mechanical/electrical performance of the returned device.Functional testing of the driveline did not identify any discrepancies that may have caused or contributed to the reported event.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Applicable risk documentation and experience with events of similar circumstances were considered; events with electrical fault alarms, are most often attributed to contamination by foreign material or a marginal driveline connection.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 7553458
• MDR Text Key: 109562858
• Report Number: 3007042319-2018-02129
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR