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

Model Number 1103

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Chest Pain (1776); Dyspnea (1816); Thrombus (2101); Dizziness (2194); Heart Failure (2206); Diaphoresis (2452); Weight Changes (2607)

Event Date 04/22/2018

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

Event Description

It was reported that the patient experienced worsening heart failure.The patient was hospitalized and required medication as treatment.The ventricular assist device (vad) remains in use.The patient is a participant in the vad destination therapy trial improved blood pressure management clinical study.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient had vad low flow alarms and shortness-of-breath, lightheadedness, chest pain, diaphoresis and weight gain before hospital admission.Treatment included bi-level positive airway pressure, diuretic therapy and adjusted vad settings, which resolved vad low flow alarms.Patient was noted to have elevated lactate dehydrogenase (ldh), subtherapeutic international normalized ratio (inr) and a clinical picture consistent with a vad occlusion/pump thrombus.The patient was treated with intravenous (iv) tissue plasminogen activator (tpa) infusion and iv and oral anticoagulation medication.The patient was discharged from the hospital.

Manufacturer Narrative

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: 7530316
• MDR Text Key: 108790807
• Report Number: 3007042319-2018-02023
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 91