BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 11499490 · Received March 16, 2021

    Report

    Report Number
    2916596-2021-00999
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 19, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# G140113. 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).

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(4), AND THE REPORTED CONGESTIVE HEART FAILURE EXACERBATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CAUSE FOR THE REPORTED EVENT ALSO COULD NOT BE DETERMINED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HM3 LVAS, SERIAL NUMBER (B)(4). THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C, IS CURRENTLY AVAILABLE. IN SECTION 1 ¿INTRODUCTION,¿ THIS IFU LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-002955 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ACUTE EXACERBATION OF CONGESTIVE HEART FAILURE ON (B)(6) 2021. HE WAS DIURESED WITH INTRAVENOUS BUMEX 4 MILLIGRAMS X 2. PATIENT STATUS WAS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021 AFTER SYMPTOMATIC RELIEF. THE EVENT RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393199 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R