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

Model Number 1103

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

Patient Problems No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.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 the ventricular assist device (vad) exhibited multiple low flow alarms and power below the normal range.The vad was explanted due to patient recovery.Post explant, the operative notes indicated that there was a substantial clot and occlusion in the inflow cannula and outflow graft, and inflow cannula malposition.The outflow cannula was also obstructed and did not back bleed upon explantation.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation product event summary: the ventricular assist device (vad) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Log file analysis revealed a decrease in power consumption and estimated flow starting on (b)(6) 2020, leading to parameters below normal operating range, and 111 low flow alarms logged on (b)(6)2020.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed evidence of thrombus within the inflow cannula of the pump.As a result, the reported low flow and inflow cannula occlusion events were confirmed.There was no evidence of thrombus within the returned segment of the outflow graft.The reported outflow graft occlusion and inflow cannula malposition events could not be confirmed due to insufficient evidence.Per the hvad instructions for use, device thrombus is a known potential complication associated with the implantation of an hvad pump.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced suspected inflow cannula occlusion accompanied by low flows and thrombosis.Of note, information received from the site indicated that the pump was explanted due to patient recovery.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported 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, incorrect position of the pump, and/or poor vad filling.Possible factors that may have led to this event include, but are not limited, to issues related to the therapeutic use of anticoagulant and antiplatelet medications, the patient¿s pre-existing history and related comorbidities, and/or the patient's complex post-operative course, including cardiac recovery, which may have contributed to the reported inflow cannula malposition.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.

Manufacturer Narrative

A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury b1 adv event/product problem updated outcome attributed to adverse event selected in b2 imf and ime code updated this regulatory report is being submitted as part of a retrospective review and remediation per d00595827 due to an fda audit observation.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 ventricular assist device (vad) exhibited multiple low flow alarms and power below the normal range.The vad was explanted due to patient recovery.Post explant, the operative notes indicated that there was a substantial clot and occlusion in the inflow cannula and outflow graft, and inflow cannula malposition.The outflow cannula was also obstructed and did not back bleed upon explantation.No further patient complications have been reported as a result of this event.

• 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: 10168017
• MDR Text Key: 195586474
• Report Number: 3007042319-2020-03645
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 12/06/2021
• Supplement Dates FDA Received: 08/21/2020; 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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
• Patient Age: 49 YR
• Patient Sex: Female