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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 Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 04/14/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01684. This report is being submitted as additional information approximate age of device - 1 year, 4 months. Manufacture conclusion: the explanted pump was returned for evaluation. The evaluation of the pump confirmed the report of suspected pump thrombosis. Upon disassembly of the device, two thrombus formations were found. Examination of the rotor revealed a fixed, non-laminated thrombus situated on the body and blades of the rotor. The thrombus revealed dark areas of denaturation indicating that the thrombus formed over an undetermined amount of time while the pump was supporting the patient. The origin of the thrombus formation could not be determined due to the lack of laminated layering. Examination of the proximal side of the outlet stator revealed a fixed, non-laminated thrombus situated in between the stator blades. The lack of laminated layering suggests that the thrombus did not form in the outlet stator. Although the origin and duration of time for which the thrombus was present in the pump cannot be conclusively determined, the lack of circumferential contact marks on the outlet bearing cup suggest that the thrombus was not present in the outlet stator for an extended period of time while the pump was supporting the patient. The remaining pump blood-contacting surfaces were free from any adhered depositions or thrombus formations. The evaluation could not determine a specific cause for the development of the observed thrombus formations. Microscopic inspection of the pump bearings, rotor, and blood-contacting surfaces did not reveal any anomalies. Electrical continuity testing of the returned portions of the driveline revealed no discontinuities or shorts. Functional testing of the pump revealed normal pump power consumption and pressure values and the pump operated 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 suspected of having device thrombosis with rising lactate dehydrogenase (ldh) over the past few days. A decision was made to remove the heartmate ii and replace with a heartmate 3 on (b)(6) 2018. On (b)(6) 2018, it was reported that the patient was doing well and would be discharged home soon.
 
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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 Key7875242
MDR Text Key120242864
Report Number2916596-2018-04090
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,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number106015
Device Lot Number5726608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2016
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: 09/13/2018 Patient Sequence Number: 1
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