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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524
Device Problem Partial Blockage (1065)
Patient Problems Atrial Fibrillation (1729); Thrombus (2101)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23 august 2017. The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). Approximate age of device 3 weeks, 6 days. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. It was reported that the patient had an aortic thrombus after lvad implant that caused a suspected outflow graft obstruction. The day of admission the patient was in symptomatic irregular rhythm and was not pacing out of it. Transesophageal echocardiography (tee) and direct current cardioversion (dccv) were planned. Tee was performed and did show possible thrombus near the outflow graft. The patient had delayed cardioversion for paroxmyl atrial fibrillation because of this. It appeared that the patient went back into normal rhythm despite the delay in dccv. Patient also had a history of deep vein thrombosis/pulmonary embolism following inferior vena cava filter placement prior to lvad placement. The patient also had a biventricular pacemaker/implantable cardioverter-defibrillator (icd). Majority of the time the patient was ventricular pacing with an underlying rhythm of atrial fibrillation. The patient experienced low blood pressure and pulsatility index events along with the irregular rhythm. The patient had atrial fibrillation prior to lvad implantation. The patient was on a lot of inotropes so some of the arrhythmias may have been medication induced. The patient was discharged with a higher international normalized ratio (inr) target. No further information was provided.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
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 Key8883828
MDR Text Key153983524
Report Number2916596-2019-03773
Device Sequence Number1
Product Code DSQ
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,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number106524
Device Lot Number6036877
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 Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 08/12/2019 Patient Sequence Number: 1
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