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

Model Number 1103

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Pain (1994); Respiratory Failure (2484); Hematuria (2558); Asystole (4442); Unspecified Heart Problem (4454)

Event Date 10/01/2023

Event Type  Death  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Event Description

It was reported that the patient was admitted to the emergency room for occasional low flows, back and pleuritic pain.  while in emergency, the patient had a computerized tomography (ct), chest x-rays and troponin drawn all were negative.  the patient was discharged.  the patient had elevated lactate dehydrogenase (ldh) of 308 (from 196) at a follow up clinic appointment.  the patient had a continuous bladder irrigation (cbi) for bloody urine but there was no evidence of pump thrombus.Labs were checked; creatinine was fine, blood cultures were negative as was a bronchoalveolar lavage (bal).  the patient was at a routine clinic appointment for multiple low flows, back and pleuritic pain and was subsequently admitted to the hospital.The patient was intubated twice and was on multiple intravenous (iv) medications for blood pressure support and heparin.  ventricular assist device (vad) flows were improved by adjusting the speed.  an echocardiogram was done which showed 10% global hypokinesis.  right and left atrial enlargement of the right ventricle could not be adequately visualized but right ventricular enlargement and dysfunction was suspected. computerized tomography (ct) of the chest showed no pulmonary emboli but did show findings consistent with chronic heart failure.  of note, the patient was found to be covid-19 positive.  the vad remains in use.  no further patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient went asystole and had been getting worse by the hour and team felt that the vad was clotting off too.The family called it off after a few rounds of epi and cardiopulmonary resuscitation (cpr).The patient subsequently expired.

Manufacturer Narrative

A supplemental report is being submitted as additional information has being received for this event and sections have been updated.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18748433
• MDR Text Key: 335934035
• Report Number: 3007042319-2024-01026
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2018
• 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; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 95 KG