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

Model Number 1103

Device Problems Obstruction of Flow (2423); Malposition of Device (2616); Pumping Problem (3016)

Patient Problems Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/19/2019

Event Type  Injury  

Event Description

It was reported the ventricular assist device (vad) patient was admitted to the hospital for suspicion of outflow graft (ofg) obstruction, as the patient presented with low flow alarms.The low flows did not respond to speed increases.An echocardiogram, (echo) showed a new aortic valve opening and significant mitral regurgitation (mir) with an unclear amount of flow going through the left ventricular assist device (lvad) cannula, which is admittedly not well-positioned as it appears now directed towards the septum.No suction or hemolysis was noted, no concern for thrombus as lactate dehydrogenase (ldh) and power were within range.It was noted that the patient had an 80-pound weight loss.It was also reported that there was suspicion of some kind of change in the patient ofg positioning, and kinking or there was obstruction of or around the ofg.It was also reported that the patient underwent intervention to the ofg with three covered stents and a reduction of the ofg gradient.The patient had immediate improvement in the flow at a much slower speed post-stent deployment.The vad was set at 2500rpm with a flow of 4-4.5 liters per minute (lpm), and the patient was continued on a low dose of blood pressure medication.The vad and outflow graft remain 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.Additional products: d1: heartware ventricular assist system ¿ outflow graft d4: model#: 1125 / catalog#: 1125 / expiration date: dd-mmm-yyyy / lot#: 1001873735.D9: no.H3: no.H4: mfg date: dd-mmm-yyyy h5: yes.H6: the codes present in section h6 correspond to components/products that comprise the reported event.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/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: 18881544
• MDR Text Key: 337414351
• Report Number: 3007042319-2024-01200
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 693565 LEAD, CD1231-40 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 87 KG