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

Device Problems Pumping Stopped (1503); Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems Chest Pain (1776); Dyspnea (1816); Diaphoresis (2452); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for chest pain, shortness of breath, and late stage right heart failure.The ventricular assist device (vad) exhibited low flows, and the patient experienced a bloody bowel movement.The patient underwent an echocardiogram and received a transfusion of packed red blood cells and fresh frozen plasma.Computed tomography angiography (cta) of the chest was concerning for thrombus in outflow tract.The vad later exhibited a constant "red heart alarm" and vad parameters read zero for speed, flows, and power.The controller was exchanged through the alarms and no flows persisted.There was no vad hum present on auscultation.The patient was restless, diaphoretic, and experienced chest pain in the subxiphoid area and a gastrointestinal bleed.The patient was started on milrinone and norepinephrine.It was reported that the vad had exhibited a total pump failure.The vad was turned off and emergently exchanged.No further patient complications have been reported as a result of this event.This event was reported in the q3 2023 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.

Manufacturer Narrative

Product event summary: one (1) pump with unknown serial number was not returned for evaluation.Review of the controller log files could not be conducted since log files were not available.The reported event could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, this event is a known potential complication associated with the implantation of a vad.Based on the risk documentation, possible causes of the 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, poor vad filling, and/or inappropriate pump rotational speed.A possible root cause of the reported "red alarm" event can be attributed but not limited to a physical disconnection of the driveline from the controller, double disconnection, a controller failure, or a pump failure.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.Additional products: d1: heartware ventricular assist system ¿ outflow graft d4: model #: / catalog #: / expiration date: / serial #: / udi #: d6a: implanted date: (b)(6) 2018 d6b: explanted date: (b)(6) 2023 d9: no h4: mfg date: h5: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.This event was reported in the q3 2023 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the 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: 18655286
• MDR Text Key: 334724182
• Report Number: 3007042319-2024-00869
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White