MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Catalog Number 106015

Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)

Patient Problem Thrombus (2101)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01637.This report is being submitted as additional information.Approximate age of device - 3 years, 2 months.Manufacturer investigation conclusion: no product was returned for evaluation.Evaluation of the submitted system controller log files revealed low flow alarms; however, a specific cause for the events could not be conclusively determined through this evaluation.The heartmate ii left ventricular assist system instruction for use (ifu) explains that pump flow is estimated from the pump power and notes that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Additionally, this document explains that physiological factors that affect the filling of the pump, and can result in reduced pump flows as long as the condition persists.The alarms and troubleshooting section of this ifu describes all alarm conditions, including the low flow hazards.A review of the device history records revealed the device met applicable specifications.No further information was provided.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) 2014.It was reported that the patient was currently in clinic for an office follow up.The patient had received a percutaneous coronary intervention (pci) procedure of the outflow graft on (b)(6) 2018 in the catheterization laboratory.During the clinic visit, elevated lvad parameters were observed.A computed tomography showed possible thrombus near the anastomosis site in the outflow graft.The patient was administered bivalirudin, asa, plavix, and coumadin.The decision was made to stent the site with two stents and balloon angioplasty on (b)(6) 2018.No additional information was provided.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• 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: 7963135
• MDR Text Key: 123671478
• Report Number: 2916596-2018-04503
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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: 10/31/2016
• Device Catalogue Number: 106015
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: 70 YR
• Patient Weight: 76