• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
Model Number 106015
Device Problems Partial Blockage (1065); Pumping Stopped (1503)
Patient Problems Hemolysis (1886); Thrombus (2101)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-01038. This report is being submitted as additional information. Approximate age of device- 1 year, 2 months, and 7 days. Manufacturer's investigation conclusion: no product was returned for evaluation. A direct correlation between the device and the report of pump thrombosis and elevated ldh could not conclusively be established through this evaluation. Additionally, evaluation of the submitted log file revealed power and flow elevations; however, a specific cause for these events could not conclusively be determined. The submitted log file contained data of an unknown timestamp. It appeared this resulted from a complete loss of power to the system controller. The entire log file also showed an active yellow wrench due to the system clock reset. The pump speed remained above the low speed limit and the pump appeared to be functioning as intended. Thrombus and hemolysis are 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
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016. It was reported that the patient was seen in an outside emergency department (ed) with a yellow wrench advisory. The ed physicians reported hearing humming and visualized the green pump running arrows symbol. The patient was actively hemolyzing with lactate dehydrogenase (ldh) greater than 8000 u/l and a recent international normalized ratio (inr) of 1. The patient has a history of noncompliance leading to hemolysis. On (b)(6) 2018, the patient was transferred and admitted to (b)(6) hospital and medical center with ldh greater than 8000 u/l. It was determined that the patient stopped all medications 2 weeks prior without clinical instruction. The patient was able to ambulate and was without symptoms. The pump was electively stopped on (b)(6) 2018 due to thrombosis and unable to maintain fixed speed. This patient is not a candidate for device exchange due to historical non-compliance since time of implant. Plan to manage medically.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7831252
MDR Text Key118726475
Report Number2916596-2018-03827
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 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model Number106015
Device Catalogue Number106015
Device Lot Number5761032
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 Received08/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2016
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: 08/29/2018 Patient Sequence Number: 1
-
-