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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 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Right Ventricular Dysfunction (2054)
Event Date 01/05/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient experienced dizziness and multiple pi (pulsatility index) events. It was suspected that the pi (pulsatility index) events were caused by volume, orthostatic blood pressure changes, right ventricular dysfunction, and small lvidd (left ventricular internal diameter). The patient had mild right ventricular dysfunction prior to being implanted with an lvad (left ventricular assist device), however it was now moderate-severe. It was unclear if the patient's right ventricular dysfunction worsened related to the vad or due to progressive heart failure. The patient was given intravenous fluids and started back on midodrine with symptomatic improvement. The patient was sent home with a planned routine follow-up as an outpatient. 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 Key9648018
MDR Text Key177142584
Report Number2916596-2020-00239
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
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 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/23/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7093825
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 Received04/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2019
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: 01/30/2020 Patient Sequence Number: 1
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