HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM 106524

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-31 for HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM 106524 manufactured by Thoratec Corporation.

Event Text Entries

[186670303] Patient weight not provided. The heartmate 3 left ventricular assist system (lvas) was implanted during the momentum 3 clinical trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23aug2017. The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4). No further information was provided. A supplemental report will be submitted when the manufacturer? S investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[186670304] The patient received a pump exchange on (b)(6) 2018 due to a driveline infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2020-01842
MDR Report Key9908072
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2018-11-05
Date Mfgr Received2020-01-31
Device Manufacturer Date2017-04-14
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BOB FRYC
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone7818528204
Manufacturer G1THORATEC CORPORATION
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 95488
Manufacturer CountryUS
Manufacturer Postal Code95488
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVENTRICULAR (ASSISST) BYPASS
Product CodeDSQ
Date Received2020-03-31
Model Number106524
Lot Number5947097
Device Expiration Date2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC CORPORATION
Manufacturer Address6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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