BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14804168 · Received June 24, 2022

    Report

    Report Number
    2916596-2022-11956
    Event Type
    Malfunction
    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
    Product Problem
    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. G.M. MONDELLINI,1 H. SHIH,1 Y. NING,2 A.C. KLEET,2 M.T. PINEDA,2 C. MAGUIRE,2 E.M. DEPHILIPPIS,1 K.M. FIDLOW,2 A. KIM,1 A. LADANYI,1 Y. NAKA,3 G.T. SAYER,1 N. URIEL,1 K. TAKEDA,3 P.C. COLOMBO,1 P.A. KURLANSKY,2 AND M. YUZEFPOLSKAYA.1 1CARDIOLOGY, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY; 2SURGERY, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY; AND THE 3CARDIAC SURGERY, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK, NY. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LVAS AND THE REPORTED DEVICE-RELATED COMPLICATIONS INCLUDING LOW FLOW ALARMS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU, REV. C, IS CURRENTLY AVAILABLE. THE SYSTEM MONITOR SECTION OF THE IFU DESCRIBES THE PUMP FLOW DISPLAY AND PULSATILITY INDEX (4-12 THROUGH 4-16) AND THE HAZARD ALARMS (4-18 AND 4-30). THIS DOCUMENT STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM (7-7 AND 7-11). THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS ALSO CURRENTLY AVAILABLE. SECTION 5 OF THIS HANDBOOK, ENTITLED "ALARMS AND TROUBLESHOOTING," DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11445. 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 26NOV2014 TO 04DEC2019 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 16NOV2014 AND 04DEC2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698193 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown