MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

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

Patient Problems Right Ventricular Failure (2055); Heart Failure (2206)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Date of event is approximate as the data were collected between january 2017 and may 2019.Vk randhawa, et al.Journal of heart and lung transplantation, volume: 39, issue: 4, pages: s407.Doi: 10.1016/j.Healun.2020.01.162 department of cardiovascular medicine, kaufman center for heart failure, cleveland clinic foundation, cleveland, oh.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported through the research abstract ¿unplanned hm3 heart failure-related hospitalizations: reclassifying post-discharge right ventricular failure¿ identifying that the heartmate 3 (hm3) is related with readmissions due to biv heart failure syndrome and right heart failure syndrome (rhfs) post-hm3 implant.This retrospective study evaluated 143 hm3 patients between january 2017 and may 2019, and found 23 patients with heart failure-related hospitalization (hfh) (16.1% prevalence), with a median time to first hfh of 65.6 days post-implant.Hfh was defined as re-hospitalization post-index implant with a fluid overload syndrome and use of parenteral diuretics.Intermacs right heart failure (rhf) is defined by elevated right atrial pressure requiring the use of varying degrees of right ventricular support, including the sole use of parenteral diuretics.The hfh was due to left heart failure syndrome (lhfs) in 11 patients (47.8%; 2 lhfs and 9 biv hfs) and predominant rhfs in 12 patients (52.2%).Twenty-one patients met criteria for intermacs-defined rhf (14.7% prevalence).By categorical phenotyping, an elevated pulmonary capillary wedge pressure (pcwp) greater than 15 mm hg was noted in 42.9% of these cases.Device was implanted at time of event.

Manufacturer Narrative

Manufacturer investigation conclusion: a direct correlation between the heartmate 3 left ventricular assist systems (lvas) and the reported right heart failure events could not be determined through this evaluation.The specific device and other case/patient information is not available and was not requested.No product was evaluated.Heartmate 3 lvas instructions for use (ifu) is currently available.This ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and warns that ¿right heart dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump¿.This section also outlines the associated treatment options, including right ventricular assist device placement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11078079
• MDR Text Key: 223800802
• Report Number: 2916596-2020-06214
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention