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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
Model Number 106015
Device Problem Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
Approximate age of device - 1 year. Thrombus was confirmed through the evaluation of the returned lvad. The pump was returned assembled with the percutaneous lead (driveline) cut approximately 6¿ from the pump housing and the distal portion of the driveline was not returned. The sealed inflow cannula and the sealed outflow cannula were returned secured to their respective pump ports. Evaluation of the sealed inflow and outflow cannulas revealed no evidence of developed depositions or thrombus formations. Examination of the rotor inlet upon disassembly revealed thrombus formations surrounding the inlet stator bearing cup and the rotor bearing ball. These thrombi appeared to have developed as one formation that was pulled apart during the pump disassembly process. The laminated structure of these thrombi and their areas of denaturation indicate that they likely formed over an undetermined period of time while the lvad was supporting the patient. A root cause for the development of these thrombi could not conclusively be determined through this evaluation. Upon removal of the observed depositions, the device was cleaned. The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed. Electrical continuity testing of the driveline did not reveal any discontinuities or shorts. The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop. The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended. A review of the device history records showed no deviations from manufacturing or quality assurance specifications. No further information was provided. The manufacturer is closing its file on this event.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. It was reported that the patient received a routine 1b status transplant on jun2018. However, the investigation of the related lvad (vad-62716) identified thrombus formations surrounding the inlet stator bearing cup and the rotor bearing ball.
 
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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 Key7815100
MDR Text Key118318166
Report Number2916596-2018-03163
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 08/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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