BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14803930 · Received June 24, 2022

    Report

    Report Number
    2916596-2022-11445
    Event Type
    Death
    Date Received
    June 24, 2022
    Date of Event
    December 4, 2019
    Report Date
    July 13, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN 16NOV2014 AND 04DEC2019. ARTICLE TITLE: SEX-BASED DIFFERENCES IN SURVIVAL AND READMISSIONS AFTER INSERTION OF HEARTMATE3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (B)(6). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LVAS AND THE REPORTED PATIENT OUTCOMES COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU, REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS MAJOR BLEEDING, INFECTION, ARRHYTHMIA, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REFERENCE TO PREVENTING INFECTION ARE PROVIDED THROUGHOUT THIS IFU, INCLUDING SECTIONS TITLED "CARING FOR THE DRIVELINE EXIT SITE" AND "CONTROLLING INFECTION." THIS IFU CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT,

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11956. IT WAS REPORTED THAT THE EVENT WAS REPORTED IN THE RESEARCH ARTICLE "SEX-BASED DIFFERENCES IN SURVIVAL AND READMISSIONS AFTER INSERTION OF HEARTMATE3 (HM3) LEFT VENTRICULAR ASSIST DEVICE". ALL PATIENTS WHO UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION FROM (B)(6) 2014 TO (B)(6) 2019 AT A SINGLE LARGE-VOLUME CENTER. ALL UNPLANNED READMISSIONS UP TO 900-DAYS OF FOLLOW UP WERE ANALYZED. READMISSIONS WERE CATEGORIZED BASED ON INTERMACS CRITERIA INTO : MAJOR BLEEDING, INFECTION, ARRHYTHMIA, VOLUME OVERLOAD, DEVICE-RELATED COMPLICATIONS, AND OTHER CAUSES. SURVIVAL WAS EVALUATED BY THE KM METHOD. INCIDENCE OF ALL-CAUSE READMISSION WAS EVALUATED USING MEAN CUMULATIVE FUNCTION METHOD. OF 182 HM3 PTS, 30 WERE WOMEN AND 152 WERE MEN. RELATIVE TO WOMEN, MEN WERE MORE COMMONLY WHITE (65.1% VS 30.0%, P=0.0003), HAD ISCHEMIC CARDIOMYOPATHY (42.8% VS 16.7%, P=0.007) AND HIGHER BASELINE SERUM CREATININE (1.45(1.2-1.8) VS 1.12(0.81-1.4)MG/DL, P<0.0001). OVERALL SURVIVAL DURING INDEX ADMISSION AND AT 900-DAYS WAS SIMILAR (WOMEN VS MEN: 93.3% VS 94.1%, P=0.9; 83.3% VS 83.0%, P=0.9, RESPECTIVELY (FIGURE 1A). CUMULATIVE INCIDENCE OF ALL-CAUSE READMISSIONS WAS SIMILAR (P=0.55). READMISSIONS SEPARATED BY ETIOLOGY WERE ALSO SIMILAR, EXCEPT WOMEN HAD A GREATER INCIDENCE OF DEVICE-RELATED READMISSIONS (19.7% VS 11.3%, P=0.05) (FIGURE 1B). THE MOST COMMON REASON AMONG DEVICE-RELATED READMISSIONS WAS LOW FLOW ALARM. MEDIAN TIME TO FIRST READMISSION (P=0.56) AND LENGTH OF STAY DURING INDEX ADMISSION (P=0.66) WAS SIMILAR. WOMEN HAVE SIMILAR SURVIVAL DURING INDEX ADMISSION AND AT 900-DAYS OF FOLLOW UP. CUMULATIVE INCIDENCE OF ALL-CAUSE READMISSION DID NOT DIFFER BY SEX, HOWEVER WOMEN WERE MORE COMMONLY ADMITTED WITH DEVICE-RELATED COMPLICATIONS. FUTURE INVESTIGATIONS INTO THE SEX RELATED LVAD OUTCOMES IS CRITICAL TO AVOID THIS TREATMENT DISPARITY. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN (B)(6) 2014 AND (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055819 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| H