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

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Urinary Tract Infection (2120); Hematuria (2558); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Lactate Dehydrogenase Increased (4567)

Event Date 05/20/2022

Event Type  Injury  

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 presented to the emergency department (ed) with blood in the urine, chest pains, heart palpitations and shortness of breath and the ventricular assist device (vad) exhibiting high watt alarms and "deranged" flows measurements.It was further reported that thrombus was suspected but was not confirmed.After an echocardiogram was performed.The patient¿s labs showed elevated lactate dehydrogenase (ldh), gross hemolysis, a subtherapeutic international normalized ratio (inr) of 1.4, and urine with evidence of free heme.The patient was administered tissue plasminogen activator (tpa) and anticoagulant medication.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 was hypertensive and given hydralazine.Echocardiogram showed left ventricle (lv) was moderately dilated, ejection fraction (ef) was 15-20%, the aortic valve had moderate regurgitation, and the left atrium (la) mildly dilated.It was noted that urine cultures were positive for escherichia coli and the patient continued cephalexin for chronic urinary tract infection (uti).

Manufacturer Narrative

### a supplemental report is being submitted for correction.Correction b5: describe event problem was corrected to include additional patient signs/symptoms and diagnostic results.Correction h6: patient ime code was 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.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.Log file analysis was not performed since log files were not available for analysis.As a result, the reported high power event could not be confirmed.Information provided by the site indicated that in addition to the high power event, the patient presented to the emergency department (ed) with blood in the urine, chest pains, heart palpitations and shortness of breath.Thrombus was suspected but was not confirmed.After an echocardiogram was performed.The patient¿s labs showed elevated lactate dehydrogenase (ldh), gross hemolysis, a subtherapeutic international normalized ratio (inr), and urine with evidence of free heme.The patient was administered tissue plasminogen activator (tpa) and anticoagulant medication.It was further reported that the patient was hypertensive and given hydralazine.Echocardiogram showed left ventricle (lv) was moderately dilated, ejection fraction (ef) was 15-20%, the aortic valve had moderate regurgitation, and the left atrium (la) mildly dilated.It was noted that urine cultures were positive for escherichia coli and the patient continued cephalexin for chronic urinary tract infection (uti).Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the high power event may be attributed to multiple factors including but not limited to external factors such as thrombus formation/ingestion, inappropriate pump rotational speed, and/or patient related factors.Per the instructions for use, thrombus, hemolysis, hypertension, cardiac arrhythmia, worsening heart failure and infection are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus, hemolysis, hypertension, cardiac arrhythmia, worsening heart failure and infection.Possible factors that may have led to the event include but are not limited to the reported patient noncompliance in taking medications or other issues related to the therapeutic use of anticoagulant and antiplatelet medications, patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.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 - 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: 14854122
• MDR Text Key: 294956066
• Report Number: 3007042319-2022-05560
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2016
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female