HEARTMATE 3 LVAS IMPLANT KIT 106524US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for HEARTMATE 3 LVAS IMPLANT KIT 106524US manufactured by Thoratec Corporation.

Event Text Entries

[185884153] 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


[185884294] It was reported that the patient expired due to sudden cardiac arrest on (b)(6) 2020. The patient experienced myocardial infarction and ischemic cardiomyopathy. The patient was found deceased with the alarm going off. There were no reported device or therapy issues that could have contributed to the patient outcome. No autopsy was performed, and the device was not explanted; therefore, will not be returned for evaluation. The backup battery was removed from the controller to stop the alarming when the family found the patient. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2020-01715
MDR Report Key9908207
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-05-24
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 LVAS IMPLANT KIT
Generic NameVENTRICULAR (ASSISST) BYPASS
Product CodeDSQ
Date Received2020-03-31
Model Number106524US
Catalog Number106524US
Lot Number6470235
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC CORPORATION
Manufacturer Address6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-31

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