MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

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

Patient Problems High Blood Pressure/ Hypertension (1908); Right Ventricular Dysfunction (2054); Hypervolemia (2664)

Event Date 07/06/2020

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 was admitted for fluid overload and right ventricular dysfunction.Patient had a right heart catheter inserted on (b)(6) 2020 that showed low filling pressure.Patient started on a dobutamine on (b)(6) 2020.Patient weaned from 5 micrograms to 3 micrograms dobutamine on (b)(6) 2020.Patient is being monitored.

Manufacturer Narrative

Section b5, h6 (patient code): additional information.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the report of right ventricular dysfunction and fluid overload could not conclusively be established through this evaluation.The patient remains ongoing on (b)(6) with no further related issues at this time.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 01jul2019.The heartmate 3 lvas ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 lvas.This document also outlines indications of right heart failure as well as possible treatments.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had pulmonary hypertension and some right sided heart failure prior to ventricular assist device implant.The patient was discharged on (b)(6)2020 with improved symptoms.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10320131
• MDR Text Key: 200243725
• Report Number: 2916596-2020-03490
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7038201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 72