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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Right Ventricular Dysfunction (2054)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided. The patient remains ongoing on the device. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that the patient presented with weakness on the right side on the 5th day after lvad implant. A brain ct showed slight ischemia in the left hemisphere. The patient is taking enalapril for hypertension post stroke. The healthcare provider noted that the patient's gradually worsening tricuspid regurgitation, now severe, dilated right ventricle, and the slit-like left ventricle with progressive shift to left despite volume correction may suggest that right ventricle dysfunction is predominating, and that lack of urine for several hours earlier that day may be an indication of early clinical signs of failure. Pump speed was reduced. No further information was provided.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
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 Key9920416
MDR Text Key186283830
Report Number2916596-2020-01859
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/11/2021
Device Model Number106524INT
Device Lot Number6763400
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 Received06/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2018
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: 04/03/2020 Patient Sequence Number: 1
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