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 Dyspnea (1816); Right Ventricular Dysfunction (2054); Hypervolemia (2664)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).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 was admitted on (b)(6) 2020 with shortness of breath, fluid overload and implantable cardioverter-defibrillator shocks.Right ventricular dysfunction was also noted.The patient also received intravenous lasix and oral diuril.They were deemed to be stable and ready for discharge on (b)(6) 2020.No pump speed adjustments made during the hospitalization.

Event Description

It was reported that the patient is at home and is still having issues with intermittent swelling and shortness of breath.The patient is using diuretics for their fluid retention.

Manufacturer Narrative

Section b5: additional information.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas and the reported event could not conclusively be established through this evaluation.The heartmate 3 lvas instructions for use (ifu) lists right heart failure and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also lists arrhythmia as a potential late postimplant complication.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.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 24jul2017.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: 10886187
• MDR Text Key: 217722119
• Report Number: 2916596-2020-05491
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524
• Device Lot Number: 6073381
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 106