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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pleural Effusion (2010); Thrombosis/Thrombus (4440)

Event Date 01/04/2021

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 pro vided, 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: heartware explant after recovery 6 years after implant in a 3-year-old child: has the game changed? the annals of thoracic surgery, july 2021; 112(1):e37-e39.Doi: 10.1016/j.Athoracsur.2020.10.061.Epub 2021 jan 4.Pmid: 33412138 additional information has been requested regarding the cause of the event, device serial number and device disposition, 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 the course of vad treatment in a pediatric patient.One patient's post-operative course was complicated by development of a thrombus on the tip of the vad inflow cannula approximately six months after implantation.The patient was noted to have recovered sufficient left ventricular (lv) function to no longer need vad support.The patient was hospitalized and underwent surgery to decommission the vad in situ.Approximately six years after vad placement, a decision was made to explant the vad.It was noted during surgery that tight adhesions were present between the vad and lung tissue.As a result of the dissections needed to mobilize the device, the patient developed a left pleural effusion, requiring post-operative high-flow oxygen support for four weeks.The status of the vad is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: one (1) ventricular assist device (vad) with unknown serial number was not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.Visual evidence provided revealed tissue growth extending through the inflow cannula of the pump.Based on the available information, the device may have caused or contributed to the reported event.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: 13474791
• MDR Text Key: 289339908
• Report Number: 3007042319-2022-02380
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 15 KG