MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problem Partial Blockage (1065)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

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).Approximate age of device ¿ 4 months.The patient remains ongoing on lvad support.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017 due to suspected pump thrombosis of another manufacturer¿s lvad system.During the procedure, the heartmate outflow graft was anastomosed to the distal part of the other manufacturer¿s original outflow graft.On (b)(6) 2018, the patient was admitted to the hospital due to low estimated pump flows and the system alarming continuously.Ct angiography showed a stenosis at the area of the graft-to-graft anastomosis of both outflow graft portions.On (b)(6) 2018, the patient was brought to the operating room where an s-shaped leftover of the other manufacturer¿s original outflow graft was observed.After opening the patient's chest, the flow values recovered.The surgeons removed the other manufacturer¿s outflow graft and made an end-to-end anastomosis from the heartmate outflow graft to a vascutek® graft.This graft was directly anastomosed to the ascending aorta.The pump flow remained stable after the procedure.No additional information was provided.

Manufacturer Narrative

The device remains in use and was not available for evaluation.A direct correlation between heartmate 3 lvas and the reported events could not be conclusively established through this evaluation.The heartmate 3 lvas instructions for use (ifu) provides an explanation of all pump parameters, including pump flow, and explains that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm.This document and the heartmate 3 lvas patient handbook describe all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The patient remains ongoing on heartmate 3 lvas and no further events have been reported.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7497339
• MDR Text Key: 107689256
• Report Number: 2916596-2018-01694
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 64