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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU Back to Search Results
Model Number 106016
Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)
Event Date 07/14/2018
Event Type  Death  
Manufacturer Narrative
Approximate age of device ¿ 1 year and 9 months the device is expected to be returned for analysis. It has not yet been received. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad). It was reported that the patient was admitted to the hospital on (b)(6) 2018 due to extensive intracerebral bleeding. In order to perform a needed operation at that time, anticoagulation therapy was abandoned. What followed next was reportedly no flow through the pump, indicating a suspicion of pump thrombosis. The pump was stopped on (b)(6) 2018, and the patient subsequently expired on (b)(6) 2018. No additional information was provided.
 
Manufacturer Narrative
No product was returned for evaluation. A correlation between the device and the reported event could not be conclusively determined. Device thrombosis, stroke, bleeding, and death are listed in the instructions for use as potential adverse events that may be associated with use of the heartmate ii left ventricular assist system. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
Additional information: it was reported by the healthcare professionals that the cause of death was not related to the pump; therefore, the pump would not be returned for evaluation. No additional information was provided.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU
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 Key7864303
MDR Text Key119819668
Report Number2916596-2018-03786
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeSI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Model Number106016
Device Catalogue Number106016
Device Lot Number5485974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2016
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: 09/11/2018 Patient Sequence Number: 1
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