MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

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

Patient Problems Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate (hm) 3 left ventricular assist system (lvas) and the reported events could not be conclusively determined through this investigation.The heartmate 3 device serial numbers and other specific case/patient information are not available and were not requested.No product was evaluated under this complaint.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1 of this ifu lists right heart failure, stroke, bleeding, infection, and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿ (under ¿right heart failure), states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options.Section 6 (under ¿caution!¿) further explains that right ventricular 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.Section 6 (under "anticoagulation") also outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas, as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Additionally, section 6 lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.Care instructions in regard to preventing infection are provided in various sections of the ifu, including caring for the driveline exit site and controlling infection.The heartmate 3 lvas patient handbook, rev.D, also contains information about caring for the driveline and preventing infection.The serial numbers or other identifying information of the products were not reported and were not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related mfr # 2916596-2024-01786.It was reported through the research article ¿the impact of small left ventricular dimension on outcomes after heartmate 3 lvad implantation¿ that the heartmate 3 (hm3) device may be associated with right heart failure, stroke, bleeding, infection, arrhythmia.This retrospective study compared 2-year survival and adverse events of the 1921 patients implanted with hm3 devices within the momentum 3 trial portfolio.The patients were compared based on the presence or absence of a left ventricular end diastolic diameter (lvedd) of < 55 mm (millimeters).Of the 1921 patients, 108 had lvedd < 55mm, and 1813 had lvedd >= 55mm.Instances of right heart failure were greater in the smaller lvedd group (41.7 vs.36.9%; p= 0.03).The need for right ventricular mechanical support, stroke, bleeding, infections, and arrhythmias were reported to have similar rates between the two groups.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19005536
• MDR Text Key: 338942824
• Report Number: 2916596-2024-01785
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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