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

Model Number 1104JP

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problems Anemia (1706); Dehydration (1807); Headache (1880); Hematoma (1884); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Muscle Weakness (1967); Paralysis (1997); Cardiovascular Insufficiency (4445); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 02/26/2024

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 was admitted to the hospital for observation due to subarachnoid hemorrhage, cephalalgia, a slight paralysis on the face and anemia with a drop of hemoglobin, thought to be caused due to oral intake of antibiotics.The patient was administered blood transfusion.A couple days after intermittent low flow alarms sounded frequently with a flow rate of 2-2.5l/min and a low flow alarm set at 2.5 l/min.A decrease of power consumption and increase pulsatilitiy were also noted, all thought to be caused by a high urine volume from the day before due to diuretics and a tendency towards intravascular dehydration.A day after the patient experienced a decline in consciousness and upper limb weakness followed by a diagnosis of cerebral ischemia, diuretics were discontinued and supplemental fluids were started.Blood pressure was in the 50's and increased to 78 mmhg, medication was initiated and discontinued couple days after.A brain and head computed tomography (ct) were performed twice with no changes or obvious bleeding, an electrocardiogram, echocardiogram and contrast ct angiography were also performed with no significant changes.The ventricular assist device (vad) remains in use. no further patient complications have been reported as a result of this event.

Event Description

It was further reported that severe tricuspid regurgitation was observed on echocardiogram.The ventricular assist device (vad) flow rate was increasing in response to supplemental fluids.It was further reported that the patient experienced ventricular compression with diastolic dysfunction and suction occurred due to hematomas around the supplying blood vessel.The patient underwent hematoma removal surgery, which was successful.

Manufacturer Narrative

A supplemental report is being submitted for additional information.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.

Manufacturer Narrative

A supplemental report is being submitted for additional information received.Updated b5.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Event Description

It was further reported that the patient had a recent computed tomography (ct) scan in response to drop in flow.Blood strain was discovered and a hematoma removal surgery was performed.

• 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: 18905131
• MDR Text Key: 337681038
• Report Number: 3007042319-2024-01245
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 1104JP
• Device Catalogue Number: 1104JP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Date Device Manufactured: 04/29/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening