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 Aortic Regurgitation (1716); Right Ventricular Dysfunction (2054); Heart Failure (2206)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient experienced right ventricular dysfunction post lvad implantation.Recurrent decompensated heart failure related to moderate continuous aortic regurgitation and right ventricular failure.The patient was started on milrinone and was subsequently discharged on (b)(6) 2017.The patient experienced recurrent exacerbation of this condition and sildenafil was off and on.Milrinone drip was adjusted accordingly.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported right heart failure and aortic regurgitation could not conclusively be established through this evaluation.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6)until (b)(6) 2019, when the patient was transplanted (refer to mfr.Report # 2916596-2019-01934).The heartmate 3 lvas instructions for use (ifu) lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.This document also discusses the potential development of right heart failure following implant and outlines the associated treatment options.The ifu 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.In addition, the ifu also explains that moderate to severe aortic insufficiency must be corrected at the time of device implant.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2017.No further information was provided.The manufacturer is closing 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: 10854492
• MDR Text Key: 216892932
• Report Number: 2916596-2020-05424
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 5955990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 111