BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8448797 · Received March 25, 2019

    Report

    Report Number
    2916596-2019-01339
    Event Type
    Death
    Date Received
    March 25, 2019
    Date of Event
    March 7, 2019
    Report Date
    June 25, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: ON 20JUN2019, IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED. PER VAD COORDINATOR, THE LVAD WAS DISCONNECTED ON 2MAR2019 AND THE PATIENT EXPIRED ON (B)(6) 2019. THE DEVICE WAS REPORTED TO HAVE OPERATED AS EXPECTED; IT WAS REPORTED THE PATIENT JUST DID NOT THRIVE ON THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH WAS NOT PROVIDED. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE ¿ 8 MONTHS 15 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT A VENTRICULAR ASSISTANCE DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT¿S CT SHOWED A BILATERAL SMALL VOLUME SUBARACHNOID HEMORRHAGE PREDOMINANTLY ALONG THE RIGHT GREATER THAN LEFT FRONTAL CONVEXITIES. NEUROSURGERY WAS CONTACTED AND THEY STATED THEY WOULD NOT BE DOING ANY INTERVENTION. THE PATIENT REMAINED STABLE AND WAS ADMITTED TO THE CICU FOR FURTHER MONITORING. A REPEAT HEAD CT ON (B)(6) SHOWED STABLE SUBARACHNOID HEMORRHAGES AND HE WAS RECOMMENDED FOR A REPEAT HEAD CT IN 48 HOURS. ON (B)(6) A NEW ONSET LEFT SIDED WEAKNESS WAS NOTED AND A STAT HEAD CT DEMONSTRATED A NEW INTRAPARENCHYMAL HEMORRHAGE WITH SURROUNDING EDEMA, MASS EFFECT AND MINIMAL MIDLINE SHIFT TO THE LEFT. DURING THE COURSE OF THE DAY ON (B)(6) THE PATIENT HAD A STEADY DECLINE IN MENTAL STATUS TO THE POINT THAT HE WAS ABLE TO FOLLOW BASIC COMMANDS, BUT HAD OVERALL INCREASE IN LETHARGY. THE PATIENT WAS STARTED ON A LOW DOSE HEPARIN DRIP FOR HIS LVAD PER NEUROLOGICAL EXAMINATION (NSX). A REPEAT HEAD CT SHOWED A LARGE INTRAPARENCHYMAL HEMORRHAGE OF THE RIGHT PARIETAL AND FRONTAL LOBES. PATIENT HAS BEEN ADMITTED TO HOSPICE FOR COMFORT MEASURES ONLY AND THE LVAD HAS BEEN DISCONNECTED. PATIENT EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243574 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6407327

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R