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

Model Number 1103

Device Problems Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems Headache (1880); Hemolysis (1886); Dizziness (2194); Hematuria (2558); Thrombosis/Thrombus (4440)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that the patient presented with headaches and lightheadedness and the ventricular assist device (vad) exhibited a tu rbulent sound upon auscultation.After log file review, it was determined that the vad exhibited an above normal power consumption, and low flow alarms.A computerized tomography (ct) scan was completed and there was no outflow graft obstruction visible, so it was presumed an inflow obstruction.The patient had questionable dark urine and the urine samples notated a small amount of blood.Their international normalized ratio (inr) levels were low at one point one and lactate dehydrogenase (ldh) levels went from 194 to 317 and had risen to 500, then 700 and kept steadily rising despite the treatment of heparin.The patient is compliant with anticoagulation therapy and remains subtherapeutic.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for device analysis and investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Log file analysis revealed a decrease in power consumption and estimated flows beginning on (b)(6) 2022, as well as 100 low flow alarms logged since on (b)(6) 2022.An increase in power consumption and estimated flows, leading to parameters above normal range, was then logged starting on (b)(6) 2022.As a result, the reported high power and low flow events were confirmed.The reported "turbulent sound" event could not be confirmed due to insufficient evidence.In addition to the high power and low flow events, information received from the site indicated that the patient presented with headaches and lightheadedness; the patient had questionable dark urine and the urine samples notated a small amount of blood.The patient's lactate dehydrogenase (ldh) levels were steadily rising despite treatment with heparin.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 reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling.Based on the available information and historical review of similar events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, the reported "turbulent sound" event may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Per the instructions for use, device thrombus and hemolysis are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse 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.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.

• 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: 14416542
• MDR Text Key: 291830733
• Report Number: 3007042319-2022-05113
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 26 YR
• Patient Sex: Male