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

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Dysphasia (2195); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Embolism/Embolus (4438)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that the patient was at home when they were noted to have slurred speech and word finding difficulties.The patient went to sleep and when they woke found they had a right facial droop and confusion.The cardiologist was contacted, and the patient was ordered to go to the hospital.When patient arrived at the hospital, they were experiencing stroke symptoms and were hypertensive.A computerized tomography (ct) scan of the head was done confirming a middle cerebral artery stroke.An international normalized ratio (inr) was done confirming that it was subtherapeutic at 1-1.1.It has been noted that the patient was non-compliant with their anticoagulation medication and was not taking their aspirin or coumadin.The patient was placed on intravenous (iv) heparin and was transferred and admitted to another hospital.The patient was put into the neuro intensive care unit (icu).An echocardiogram was done which showed left ventricular end diastolic dimension of 4.2cm.Computed tomography angiography (cta) of the brain which showed a large left middle cerebral artery occlusion suggesting cardiogenic embolism.Another ct was done which showed a new occlusion of the distal left m2 segment with distal reconstitution.It was noted that the patient is alert, oriented, and stable with improving symptoms.Also, upon log file review it was noted that the ventricular assist device (vad) had multiple low flow alarms and revealed motor start events with parameters outside of typical range.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.Continuation of d10: 694765 & 407652 leads implanted (b)(6) 2011.This information was received from the mechanical circulatory support product surveillance registry study.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 multiple vad motor start events that were above normal range may have occurred on a controller that was being used for training.It was further reported that the patient received intravenous (iv) medication.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• 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: 18809695
• MDR Text Key: 336582047
• Report Number: 3007042319-2024-01132
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2019
• 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
• Treatment: DTMA1Q1 ICD, 479888 LEAD
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG