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

Model Number 1103

Device Problem Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Dizziness (2194); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/07/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) exhibited low flows due to a malpositioned inflow cannula and the patient experienced severe dizziness, abdominal pain and tightness.It was also reported that the patient experienced a gastrointestinal bleed (gib) which was confirmed with a fecal occult blood test.Labs were performed and the patients international normalized ratio (inr) was at a goal of 2-3 and had a decrease in hematocrit.A chest x-ray was performed and confirmed the patient had worsening heart failure.The patient was treated with intravenous (iv) fluids and blood transfusion.The patient was compliant with their anticoagulation therapy.No intervention was performed to correct the malposition of the inflow cannula.The vad remains in use.No further patient complications have been reported as a result of this event.

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 analysis.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.The reported low flow event was confirmed through log file analysis which revealed several instances of power consumption and estimated flows below the normal operating range within the last 14 days of available data leading up to 07-sep-2022; however, no alarms were logged within the analyzed period.Information provided by the site indicated that the inflow cannula was malpositioned.Additionally, it was reported that patient experienced severe dizziness, abdominal pain and tightness.It was also reported that the patient experienced a gastrointestinal bleed (gib) which was confirmed with a fecal occult blood test.Labs were performed and the patients international normalized ratio (inr) was therapeutic and had a decrease in hematocrit.A chest x-ray was performed and confirmed the patient had worsening heart failure.The patient was treated with intravenous (iv) fluids and blood transfusion.No intervention was performed to correct the malposition of the inflow cannula.The reported malpositioned inflow cannula event could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the reported 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, and/or incorrect positioning of the pump.A possible root cause of the reported pump malposition event may be attributed, but not limited, to surgical technique during implant.Per the instructions for use, bleeding and worsening heart failure are known potential complications associated wi th the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient did not have a history of similar 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: 15411972
• MDR Text Key: 299788473
• Report Number: 3007042319-2022-07224
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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; Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male