MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-00710.This report is being submitted as additional information.The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device - 110 days.Manufacturer's investigation conclusion: the report of low flow hazard alarms was confirmed through the analysis of the submitted system controller and lvad log files; however, the report of inflow cannula malpositioning could not confirmed through this evaluation.The submitted system controller and lvad log files showed that the system appeared to be operating as intended.A specific cause for the low flow hazard events could not be conclusively be determined through this evaluation.The heartmate 3 lvas ifu warns that care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of an inlet obstruction.This ifu provides information on all system alarms, including the low flow hazard alarm, and states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm.Changes in patient conditions can result in low flow.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.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that frequent low flow alarms occurred the morning of (b)(6) 2018.The patient was medically managed; however, the low flow alarms persisted.As part of troubleshooting, the system controller was exchanged; however, the change did not resolve the alarms.The lvad speed was manually decreased; however, the alarms persisted.On (b)(6) 2018, the patient continued to be asymptomatic.The patient's left ventricle had decreased in size by 3 cm.Because of this remodeling, the inflow cannula had likely changed position enough to cause the low flow alarms.No additional interventions were pursued, and the patient was discharged.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7962371
• MDR Text Key: 123671315
• Report Number: 2916596-2018-04550
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 6078489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 99