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

Catalog Number 106524

Device Problems Partial Blockage (1065); Kinked (1339)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the momentum 3 (short term, cap, or long term) 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 ¿ 4 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 patient was admitted on (b)(6) 2018 for dyspnea and fatigue.Low flow alarms were produced by the lvad.On (b)(6) 2018 right heart catheterization with ramp study found minimal change with speed adjustments there were continuous low flow alarms throughout procedure.A ct angiogram found that the lvad inflow cannula, outflow graft, and driveline were in regular position, and free from thrombus.However the distal anastomosis of the outflow graft had focal kinking with approximately 50% cross-sectional area reduction at the site of kinking.It was also observed that the inflow cannula tip appeared to be moderately obstructed at end systole secondary to near obliteration of the left ventricle (lv) cavity at the cannula tip.There was also diastolic leftward shift of the interventricular septum secondary to marked right ventricular (rv) enlargement and apparent rv volume overload, all of which reportedly likely contributed to hemodynamic compromise.The patient¿s treatment included increase of milrinone 0.3mcg/kg/min, silencing low flow alarms for 4 hour period if needed, and plan for picc when inr allowed warfarin per pharmacy.It was reported that the patient was discharged on (b)(6) 2017.

Event Description

It was reported on (b)(6) 2018 that the patient had intermittent low flow alarms nearly since implant and was asymptomatic.Milrinone was increased for right heart failure, as was previously reported.Subsequently inotrope was decreased post-right heart catheterization (rhc).Rhc found adequate flow in the outflow graft (ofg).Revatio was also discontinued and multiple fluid boluses were administered.Lvad flow remained in the 3 lpm range.

• 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: 7325951
• MDR Text Key: 101955122
• Report Number: 2916596-2018-00898
• 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: study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• 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: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63