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

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Type  Injury  

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.

Event Description

It was reported that one day post implant of the ventricular assist device (vad), there was a gradual decrease in vad support with increased suction events and decreased flow.The chest tube output had decreased and there was mediastinal bleeding with concern for possible tamponade.The patient was taken to the operating room (or) for mediastinal exploration and a thrombus was evacuated.The vad remains in use.No further patient complications have been reported as a result of this event.This event was reported in (b)(6) registry that tracks clinical outcomes of pediatric patients on ventricular assist device (vad) support.The data registry does not contain device identifying information, facility 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

A supplemental report is being submitted for investigation completion.This event was reported in the (b)(6) 2020 action data registry that tracks clinical outcomes of pediatric 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.Product event summary: a pump with unknown serial number was not returned for evaluation.The reported low flow event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the low flow event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed.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.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11002807
• MDR Text Key: 221267302
• Report Number: 3007042319-2020-07683
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 58