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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106016
Device Problems Failure to Align (2522); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient had elevated power/flows associated with pi events. The patient was recently implanted with a new heartmate ii pump on (b)(6) 2021 due to suspected short-to-shield. Malposition of inflow cannula was the suspected cause, which the patient was known to have. Currently the patient has no symptoms. Blood lab analysis did not reveal hemolysis markers and blood pressure is in normal range. There was no blood in urine analysis. Echocardiogram did not show lv unloading issues. The patient is currently on fluid management and optimalisation of pump rpm speed.
 
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Brand NameHEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key11327616
MDR Text Key234488238
Report Number2916596-2021-00826
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number106016
Device Catalogue Number106016
Device Lot Number6538461
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 Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2018
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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