MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

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

Patient Problem Thrombus (2101)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device - 6 years.The patient remains on lvad support.Additional information was requested but was not 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) 2011.It was reported that the patient was admitted with headaches and double vision.The patient had computed tomography (ct) of the chest revealing the outflow tract of the lvad demonstrated circumferential echogenic thrombus which narrowed the lumen by approximately 20-30%; and that there was no thrombus in the conduit connecting the lvad to the ascending aorta.Echocardiogram report stated that there was a mildly dilated left ventricle with severely reduced systolic function, and turbulent flow in the region of the outflow graft suggestive of obstruction and possible kinking.Right heart catheterization and ventriculography both confirmed an issue with flow through the device.Additional information was requested but was not provided.

Manufacturer Narrative

A direct correlation between the left ventricular assist system (lvas) and the reported thrombus could not be determined.Thrombus is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: left ventricular assist device outflow conduit stenosis.Successful stenting of lvad outflow conduit anastomotic stenosis with 11 x 39 mm viabahn vbx covered stent.The left ventricular assist device was temporary set off and respirations were held by anesthesia.We subsequently deployed an 11 x 39 mm gore viabahn vbx balloon expandable stent at the level of the stenosis at the anastomosis of the left ventricular assist device outflow conduit and aorta.We then immediately post dilated using an armada 14 x 40 x 135 mm balloon.This time left ventricular assist device was restarted.The patient regained spontaneous respirations.The procedure was tolerated well without any complications.The patient left the cardiac catheterization lab hemodynamically stable and chest pain-free.Left ventricular assist device outflow conduit angiography.The images obtained were suboptimal, but demonstrated possible stenosis at the anastomosis of the left ventricular assist device in aorta.Significant reduction in left ventricular assist device conduit to aorta pressure gradient with decreased pressure gradient.

• Brand Name: HEARTMATE II LVAS
• 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: 7031011
• MDR Text Key: 92036221
• Report Number: 2916596-2017-02743
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• 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: 50 YR
• Patient Weight: 96