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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 Mechanical Problem (1384)
Patient Problems Right Ventricular Dysfunction (2054); Thrombus (2101)
Event Date 02/21/2020
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's pump was exchanged due to pump thrombosis. The patient had ventricular tachycardia arrest and the pump stopped and restarted but flows did not return and the speed decreased to 3500 rpm. The patient was reintubated and resuscitation was initialed including cardioversion and cpr. Pump auscultation was normal at the time. The patient was emergently taken to the operating room for bypass and transesophageal echocardiography (tee) revealed dilated left ventricle and absent flow from the lvad. The pump was exchanged due to excess clot in the inflow which was likely due to the stasis in during arrest. The patient was placed on a tandem rvad with oxygenator, due to right ventricular dysfunction requiring increasing inotrope support. The patient's chest was left open and the explanted pump was returned.
 
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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 Key9831819
MDR Text Key184317005
Report Number2916596-2020-01113
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 health professional
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7370324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2020
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: 03/13/2020 Patient Sequence Number: 1
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