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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Unspecified Infection (1930); Right Ventricular Dysfunction (2054)
Event Date 01/17/2019
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 trial is locked. The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). The patient remains ongoing with the lvad device. 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 with a history of heart failure with reduced ejection fraction (hfref) with 2 out of 2 nonischemic cardiomyopathy (nicm) status post bridge-to-transplant m3 lvad, mitral valve replacement (mvr), tricuspid valve replacement (tvr ) on day of transplant on (b)(6) 2017. On (b)(6) 2019 the patient presented with pseudomonad driveline infection and rv dysfunction, paroxysmal af, dm, ckd and gout with recent admissions for viral uri presents for diarrhea one 1 week and vomiting 2 times a day. No fevers or chills reported however there is still reports some drainage of the drive line. On admission patient was found to be febrile 101. 3 and cxr w/o acute infectious process, bcx sent and pending. Additional information reported that this is an ongoing event and treatments included hospitalization, changes to medication and parenteral antibiotics. Plan of care by the infectious disease team is to manage symptoms and administer cipro 750mg by mouth twice a day. No additional information reported.
 
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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 Key9643963
MDR Text Key177140065
Report Number2916596-2020-00203
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 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Model Number106524
Device Lot Number5936874
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 Received03/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2017
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: 01/29/2020 Patient Sequence Number: 1
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