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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2019

Event Type  Injury  

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.Product event summary: one (1) controller and pump with unknown serial numbers were not returned for evaluation.Review of the controller log files could not be conducted since log files were not available.There is insufficient information regarding the reported event.As a result, the reported vad stopped event could not be confirmed.Additional products: brand name: heartware ventricular assist system ¿ pump.Model #: unk, catalog #: unk, expiration date: unk, serial #: unk, udi #: (b)(4).Device available for evaluation: no.Mfg date: unk.Labeled for single use: yes.(b)(4).This event was reported in the q4 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was hospitalized with acute ventricular assist device (vad) stoppage and underwent vad exchange.It was reported that the controller had an unspecified issue as well.The controller remains in use.No patient complications were reported as part of the event.This event was reported in the q4 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.

Manufacturer Narrative

A supplemental report is being submitted for a correction.The manufacture narrative is being corrected to update the product event summary.New product event summary is below.Product event summary: one controller and one hvad pump with unknown serial numbers were not returned for evaluation.Review of the controller log files could not be conducted since log files were not available.There is insufficient information regarding the reported event.As a result, the reported vad stopped event and unspecified controller issue event could not be confirmed.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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 - CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9877803
• MDR Text Key: 196433771
• Report Number: 3007042319-2020-02419
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 96