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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 106015
Device Problems Mechanical Problem (1384); Pumping Stopped (1503); Infusion or Flow Problem (2964)
Patient Problem Right Ventricular Dysfunction (2054)
Event Date 04/21/2020
Event Type  Injury  
Manufacturer Narrative
The patient remains ongoing with the lvad device. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that on (b)(6) 2020, the patient came to the clinic after calling to report having a continuous tone while on batteries. Upon interrogation 2 pump stops were revealed; however, the patient reported being asymptomatic. The patient¿s log files were being sent to tech service and reported that the patient hardly ever uses wall power while at home. The reported alarms consisted of no external power, low flow, low voltage, power cable disconnected and pump off. Log files submitted showed low speed and pump stop events while on battery power and this type of behavior has been linked to potential issues with the percutaneous lead. The patient did not have any additional pump stops while inpatient. The patient underwent a right heart catheterization (rhc) on (b)(6) 2020 which revealed high pulmonary capillary wedge pressure (pcwp) related to patient noncompliance with diet and fluid restriction. The patient¿s rv function is still moderately dysfunctional and was started on milrinone while swan remains in place. Palliative care was consulted with respect to ongoing phase to phase and surgical risks associated with another device exchange. No additional information provided.
 
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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 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 Key10020089
MDR Text Key191537269
Report Number2916596-2020-02386
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 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model Number106015
Device Catalogue Number106015
Device Lot Number5823554
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 Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2017
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: 05/04/2020 Patient Sequence Number: 1
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