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

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problems Abdominal Pain (1685); Liver Damage/Dysfunction (1954); Nausea (1970); Vomiting (2144); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 06/17/2022

Event Type  Death  

Event Description

It was reported that the patient was admitted with complaints of nausea, vomiting, and abdominal pain, and the ventricular assist device (vad) exhibited low flow alarms.The patient was found to have significantly elevated lactate dehydrogenase (ldh) and lactic acid.A computed tomography angiography (cta) scan of the chest/abdomen showed mesenteric stenosis.The patient was evaluated by vascular surgery and was found to not be a surgical candidate.The patient further decompensated and had elevated ldh, liver function tests (lfts) and lactic acid.An exploratory laparotomy was performed.No ischemic bowel was found, but the patient progressed further due to metabolic acidosis and the family withdrew care.An echocardiogram was performed and showed some ability to close the aorticvalve but a partial pump thrombus was reported as the cause for the elevated ldh and lfts.The patient subsequently expired.

Manufacturer Narrative

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

A supplemental report is being submitted for device evaluation.Product event summary: (b)(6) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the pe rformance of the device in relation to the reported event.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front preload measurement and rear housing disc curvature were found to be deviating from release specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Internal pathological report revealed no evidence of thrombus within the device.Review of log files was not performed since log files were not available for analysis.As a result, the reported low flow event could not be confirmed.Information received from the site indicated that, in addition to low flows, the patient experienced nausea, vomiting, and abdominal pain, and a computed tomography angiography (cta) scan of the chest/abdomen showed mesenteric stenosis.The patient further decompensated and had elevated ldh, liver function tests (lfts), and lactic acid.An exploratory laparotomy was performed and no ischemic bowel was found, but the patient progressed further due to metabolic acidosis.An echocardiogram showed some ability to close the aortic valve but a partial pump thrombus was reported as the cause for the elevated ldh and lfts.Care was withdrawn and the patient subsequently expired.Based on the available information, the device may have 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, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, thrombus, hepatic dysfunction, and death are known potential complications 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.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: 14876118
• MDR Text Key: 295054157
• Report Number: 3007042319-2022-06355
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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): Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG