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); Noise, Audible (3273)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00994.This report is being submitted as additional information.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, ide# (b)(4).Approximate age of device ¿ 8 months.Manufacturer's investigation conclusion: although the reported pump noises were confirmed through the submitted videos, a specific cause could not conclusively be determined through this evaluation.The videos depicted one instance of low flow and high pi associated with the patient turning to lie on the left side, as reported by the account; however, the reported low flow hazard alarms could not be confirmed, as no hazard alarms were recorded in the log files that were submitted for evaluation, and the submitted video showed that the calculated average flow did not remain under the 2.5 lpm threshold long enough to trigger an alarm.The system controller log life contained data from 14dec2017 at 7:53:03 through 14dec2017 at 14:15:25.No hazard alarms were recorded, and the pump appeared to function as intended.The device remains implanted and the patient continues on lvad support.The heartmate 3 lvas ifu and heartmate 3 lvas patient handbook instruct patients to call their hospital contact right away if they notice a change in how the pump sounds, feels, or works.Even small changes should be reported.The ifu also explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.A review of the device history records revealed the device met applicable specifications.No further information is available.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 the pump was making abnormal noises.On (b)(6) 2018, sporadic low flow events were observed that correlated with a metallic noise coming from the pump.Ct showed was unremarkable for outflow graft kinking or obstruction due to positional changes.On (b)(6) 2018, the pump was making noises with positional changes.Imaging in the catheterization laboratory with lv gram revealed patient had good flow through the inflow and outflow when lying flat on the back.When lying on the left lateral side, vad parameters changed, and imaging revealed dynamic inflow obstruction with septal tissue moving laterally impinging on the inflow graft resulting in substantially reduced flow in the outflow graft.Due to this, the decision was made to increase blood pressure, promote right to left throughput, and maintain adequate volume.The patient has been discharged.No additional information was provided.

• 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: 7959313
• MDR Text Key: 125605134
• Report Number: 2916596-2018-04485
• 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: company representative,health
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 5881850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2017
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115