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

Model Number 106524US

Device Problem Malposition of Device (2616)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported inflow cannula malpositioning could not conclusively be determined through this evaluation as no images were provided by the account.The patient was implanted with heartmate 3 left ventricular assist system (lvas), serial number (b)(4), on (b)(6) 2021.During the implant procedure, the patient¿s heart was emptied to repair a valve.The apex was then located, and the apical cuff was placed/cored while the heart was empty.After the heart was filled, it was noted that pump was posterior/lateral in positioning and the inflow cannula was more perpendicular to the septum than it was parallel.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(4).No further information regarding the event has been provided at this time.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), rev.C is currently available.Section 5 of this document outlines steps to ensure the proper placement of the pump and inflow cannula.Care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump can also be found in this section.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the during implant, the pump was posterior/lateral in positioning and the inflow cannula was more perpendicular to the septum rather than parallel.It was also noted that at the time of implant, the patient's heart was emptied to repair a valve, the apex was then located and the apical cuff was placed and cored while the heart was still empty.When the heart filled, the inflow cannula was not in the ideal location.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13942598
• MDR Text Key: 289664192
• Report Number: 2916596-2022-01865
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8000479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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 Age: 9 YR
• Patient Sex: Male
• Patient Weight: 27 KG
• Patient Ethnicity: Non Hispanic