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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 Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Left Ventricular Dysfunction (1947); Right Ventricular Dysfunction (2054); Blood Loss (2597); Ischemia Stroke (4418)
Event Date 12/17/2020
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
On (b)(6) 2020 the patient experienced a post-operative ischemic stroke. Low flow alarms were also recorded. The patient was given heparin during the procedure and was partially reversed with protamine due to concerns for bleeding at the operative site. The patient also received platelets and the plan was to start aspirin and heparin the morning after, giving the site time to heal. A ramp echo revealed severely reduced left ventricle function. No acoustic windows were available. Pump speed was decreased from 5200 rpm to 5000 rpm due to multiple low flow alarms and pulsatility index (pi) events. There were two re-openings for bleeding. The patient was intubated and put on continuous renal replacement therapy (crrt) and nitric for severe right ventricle dysfunction. The patient would be monitored regarding the need for temporary right ventricle support.
 
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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 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 Key11116305
MDR Text Key225052474
Report Number2916596-2020-06431
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
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 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/03/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7026965
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 Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2019
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: 01/05/2021 Patient Sequence Number: 1
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