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

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Hemorrhage, Cerebral (1889); Unspecified Infection (1930); Thrombosis (2100); Blood Loss (2597)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device 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.Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The baseline gender/age of the patients represented in the article is male/(b)(6).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: early signatures of bleeding and mortality in patients on left ventricular assist device support: novel methods for personalized risk-stratification.Biomarkers, july 2019; 24(5):448-456.Doi: 10.1080/1354750x.2019.1609089.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 discussed how platelet activity and inflammatory biomarkers may predict risks for 1-year adverse events for patients using vads for left ventricular support.Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.There were patients on vad support who experienced thrombocytopenia, drive line infections requiring treatment, multiple re-hospitalizations, gastrointestinal bleeding, hemorrhagic/embolic strokes, and pump thrombosis requiring medical/surgical intervention.The status/location of the vads is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: pumps with unknown serial numbers were not returned for evaluation.Review of the controller log files could not be conducted since log files were not available for analysis.Review of the sterility certificates could not be conducted since the serial numbers are unknown.Based on the investigation conducted, there is no evidence to suggest that a device malfunction caused or contributed to the reported events.Possible clinical factors that may have contributed to these events include the patients¿ 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 patients¿ complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9533784
• MDR Text Key: 176446652
• Report Number: 3007042319-2019-14668
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR