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

Catalog 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  Injury  

Manufacturer Narrative

Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial, ide (b)(4).(b)(4).Approximate age of device ¿ 8 months.  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.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 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: 7345587
• MDR Text Key: 102638759
• Report Number: 2916596-2018-00994
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 106524
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115