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

Model Number 1103

Device Problems Increase in Suction (1604); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 200h18 tissue valve, implant date: (b)(6) 2014.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 patient was admitted due to a bacterial infection, and was given antibiotics and vasopressors.The patient was then scheduled for chest exploration and washout procedure due to contamination of the ventricular assist device (vad).The vad was mostly explanted, except for about 20 centimeters of the outflow graft that was left anastomosed to the aorta, and the sewing ring which was left in place with a plug placed.A couple days later a new vad was implanted.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that before the vad exchange, the vad was running rough with signs of thrombus in the ventricle and patient received vasopressors medication.

Manufacturer Narrative

A supplemental report is being submitted for additional information.: b5: newly added the ventricular assist device (vad) was running rough with signs of thrombus in the ventricle and patient received v asopressors medication.H6 ime code was added e0514 for thrombus and fdd was added a141302, imf for surgical intervention and vad replacement.Investigation of this event is pending and a supplemental report will be sent upon its completion.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 further reported that the patient experienced sepsis.

Manufacturer Narrative

A supplemental report is being submitted for additional information.B5: additional information was received regarding patient signs/symptoms.Investigation of this event is pending and a supplemental report will be sent upon its completion.### 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

Corrections: b1, h6 a supplemental report is being submitted for corrections and investigation completion.B1 corrected from adverse event to adverse event product problem.H6 device codes corrected from a24, a141302 to a0508.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Log file analysis was not performed since log files were not available for analysis.Information provided by the site indicated that the patient underwent a chest exploration, a washout procedure and a vad exchange procedure due to a bacterial infection and sepsis.Additionally, it was reported that the vad was ¿running rough¿ with signs of thrombus in the ventricle.The patient was treated with vasopressors and antibiotics.The reported "vad running rough" event could not be confirmed due to insufficient evidence.There is no evidence to suggest that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation, the ¿vad running rough" event may be attributed to multiple factors including, but not limited to, thrombus within the device leading to impeller imbalance or the placement of the vad which allows contact with fixed or rigid anatomical structure.Per the vad instructions for use, device thrombus and infection are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus 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 d isease, 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.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Newly added b5.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.

Event Description

It was further reported that the patient was transplanted.

• 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
• MDR Report Key: 11552715
• MDR Text Key: 241731944
• Report Number: 3007042319-2021-02061
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4968-35 (X2) LEAD, W1DR01 PACEMAKER; 4968-35 (X2) LEAD, W1DR01 PACEMAKER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 30