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

Model Number 1104

Device Problems Pumping Stopped (1503); Pumping Problem (3016); Material Split, Cut or Torn (4008)

Patient Problems Malaise (2359); Unspecified Mental, Emotional or Behavioural Problem (4430); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific de vice information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and, upon receipt, a supplemental report will be submitted accordingly.Referenced article: left ventricular assist device failure requiring percutaneous conduit occlusion with a vascular plug.Jacc: cardiovascular interventions, march 22, 2021; 14(6):e61-e63.Doi: 10.1016/j.Jcin.2020.12.034.Pmid: 33736789.Additional information has been requested regarding the cause of the event, device serial number and patient demographic data, 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.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

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article was a case report on percutaneous decommissioning of a vad in situ.One patient developed a psychotic episode and transected the driveline causing pump shutdown.The patient was hospitalized with worsening heart failure symptoms and a transthoracic echocardiogram (tte) noted retrograde blood flow through the left vad (lvad) circuit.The patient was deemed ineligible for a pump exchange or heart transplant.Percutaneous/endoscopic closure of the lvad conduit was conducted using a vascular plug.The patient was discharged from the hospital with no noted complications; however the patient was later re-admitted for malaise from medication non-compliance.The vad remains de-activated within the patient.No further patient complications have been reported as a result of this event.

Event Description

Additional information received from the physician/author stated that the vad and driveline did not directly contribute to the observed event.The pump/driveline failure was noted to be entirely due to the patient's actions during a psychotic episode.

Manufacturer Narrative

A supplemental report is being submitted for additional information.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 investigation completion.Product event summary: the driveline cable associated with the ventricular assist device (vad) was not returned for evaluation.Review of log files was not performed since log files were not available for analysis.As a result the reported event could not be confirmed due to insufficient evidence.Information received from the site indicated that that the patient developed a psychotic episode and cut the driveline cable, resulting in the vad stopping.The patient was hospitalized with worsening heart failure symptoms and a transthoracic echocardiogram (tte) noted retrograde blood flow through the left vad circuit.The patient was deemed ineligible for a pump exchange or heart transplant and percutaneous/endoscopic closure of the lvad conduit was conducted using a vascular plug.The patient was discharged from the hospital with no noted complications; however the patient was later re-admitted for malaise from medication non-compliance.Additional information received from the physician/author stated that the vad and driveline did not dire ctly contribute to the observed event and was likely due to the patient's psychiatric episode.Per the instructions for use, psychiatric episodes and worsening heart failure are known potential complications associated with the implantation of a vad.Based on the available information, the device may have caused or contributed to the reported event.There was no evidence that the patient had a history of similar adverse events.Based on the available information, the most likely root cause of the reported pump stop event can be attributed to the reported cutting of the driveline, as mentioned in the reported event details.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/DRIVELINE
• 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: 13388597
• MDR Text Key: 286448344
• Report Number: 3007042319-2022-00384
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Date Device Manufactured: 04/11/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 102 KG