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

Model Number 1103

Device Problems Increase in Suction (1604); Malposition of Device (2616)

Patient Problem Tachycardia (2095)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the relation of the vad to the vt and suction, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post ventricular assist device (vad) implant, the patient experienced ventricular tachycardia (vt) and suction events.The vad remains in use.No further patient complications have been reported as a result of this event.

Event Description

It was also reported that the ventricular assist device (vad) inflow cannula was malpositioned.

Manufacturer Narrative

A supplemental report is being submitted for a correction.The event description and device codes were corrected to include information regarding the positioning of the vad, which was not included in prior reports.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 device analysis.Investigation completion, and a correction.The implant date in section d6a was corrected from (b)(6) 2020 to (b)(6)2019.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Log file analysis revealed seven (7) low flow alarms logged on (b)(6) 2019.Of note, the data file covering the reported event date was not available for analysis.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, poor vad filling, and/or inappropriate pump rotational speed.Information received from the site indicated that the patient experienced ventricular tachycardia.Based on the limited information available, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Per the instructions for use, cardia arrhythmia is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.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.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Log file analysis revealed seven low flow alarms logged on (b)(6) 2019.Of note, the data file covering the reported event date was not available for analysis.As a result, the reported suction event could not be confirmed.Information received from the site indicated that the patient experienced ventricular tachycardia.It was further reported that the vad inflow cannula was mal-positioned.The reported pump malposition event could not be confirmed due to insufficient information.Based on the limited information available, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation and the available information, a possible root cause of the observed low flow event and reported suction event can be attributed to multiple factors including but not limited to inappropriate positioning of the pump, thrombus at the inflow cannula, poor vad filling, and/or inappropriate pump rotational speed.A possible root cause of the reported malposition event can be attributed, but not limited, to surgical technique during implant.Per the instructions for use, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.Of note, the patient's reported medical history indicated that the patient had a history of paroxysmal atrial fibrillation and non-sustained ventricular tachycardia.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, issues related to the therapeutic use of anticoagulant and antiplatelet medications, the patient's complex post-operative course, and/or the reported improper positioning of the inflow cannula during implant.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.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: 11193589
• MDR Text Key: 227511033
• Report Number: 3007042319-2021-00265
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2021

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: 12/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 03/04/2021; 03/12/2021
• Supplement Dates FDA Received: 02/26/2021; 03/05/2021; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR