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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
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.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
Type of DeviceLEFT 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 Key7963135
MDR Text Key123671478
Report Number2916596-2018-04503
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
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 Received10/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Catalogue Number106015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2018 Patient Sequence Number: 1
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