BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 12967454 · Received December 9, 2021

    Report

    Report Number
    2916596-2021-07336
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    November 19, 2020
    Report Date
    March 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER WERE DOCUMENTED AS UNKNOWN. THE DEVICE WAS IMPLANTED AT TIME OF EVENT. THE DATE OF THE EVENT HAS BEEN APPROXIMATED, AS THE DATA WAS COLLECTED UNTIL (B)(6) 2020. THE AUTHOR OF THE ARTICLE IS LISTED AS FOLLOWS: FAROOQ H. SHEIKH, ET AL. CIRC HEART FAIL. 2021;14:E008360. DOI: 10.1161/CIRCHEART FAILURE.120.008360, (B)(6) HOSPITAL HEART AND VASCULAR CENTER, CENTER FOR ADVANCED HEART DISEASE, BOSTON. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER WERE DOCUMENTED AS UNKNOWN. THE DEVICE WAS IMPLANTED AT TIME OF EVENT. THE DATE OF THE EVENT HAS BEEN APPROXIMATED, AS THE DATA WAS COLLECTED UNTIL (B)(6) 2020. THE AUTHOR OF THE ARTICLE IS LISTED AS FOLLOWS: FAROOQ H. SHEIKH, ET AL. CIRC HEART FAIL. 2021;14:E008360. DOI: 10.1161/CIRCHEART FAILURE.120.008360, (B)(6) HOSPITAL HEART AND VASCULAR CENTER, CENTER FOR ADVANCED HEART DISEASE, (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HM3 LVAS IFU LISTS STROKE, BLEEDING, INFECTION, RIGHT HEART FAILURE, THROMBUS, AND HYPERTENSION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU, AS WELL AS THE HM3 LVAS PATIENT HANDBOOK, ALSO PROVIDES INFORMATION REGARDING HOW TO PREVENT INFECTION. IN ADDITION, THIS DOCUMENT OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN AND INR RANGE. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿IMPACT OF RACE ON CLINICAL OUTCOMES AFTER IMPLANTATION WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE: AN ANALYSIS FROM THE MOMENTUM 3 TRIAL¿ THAT THE HEARTMATE 3 (HM3) MAY BE RELATED TO HIGHER MORBIDITY BURDEN, RISK OF STROKE, BLEEDING AND SMALLER GAINS IN FUNCTIONAL CAPACITY AND QUALITY OF LIFE IN BLACK PATIENTS, BUT NO DIFFERENCE WAS OBSERVED FOR MAJOR INFECTION (INCLUDING DRIVELINE INFECTION, RIGHT HEART FAILURE, PUMP THROMBOSIS. A TOTAL OF 960 HM3 PATIENTS (WHITE: 675, BLACK: 285) WERE INCLUDED IN THIS RETROSPECTIVITY STUDY WITH CLINICAL EVENTS COMPLETED AS OF (B)(6) 2020. THE MAIN RESULTS WERE AS DESCRIBED: BLACK PATIENTS WERE AT HIGHER RISK OF ADVERSE EVENTS (CALCULATED AS EVENTS PER 100 PATIENT -YEARS), INCLUDING BLEEDING (75.4 VERSUS 63.5; P0.0001), STROKE (9.5 VERSUS 7.2; P0.0183), AND HYPERTENSION (10.1 VERSUS 3.2; P0.0001). THE 6-MINUTE WALK DISTANCE WAS NOT DIFFERENT AT BASELINE AND 6 MONTHS BETWEEN THE GROUPS, HOWEVER, THE ABSOLUTE CHANGE FROM BASELINE WAS GREATER FOR WHITE PATIENTS (MEDIAN: +183.0, INTERQUARTILE RANGE, 42.0 335.3 ,VERSUS +163.8, INTERQUARTILE RANGE, 42.3 315.0 METERS, P0.01). THE ABSOLUTE QUALITY OF LIFE MEASUREMENT (EUROQOL GROUP, 5-DIMENSION, 5-LEVEL INSTRUMENT VISUAL ANALOG SCALE) AT BASELINE AND 6 MONTHS WAS BETTER IN THE BLACK PATIENT GROUP, BUT RELATIVE IMPROVEMENT FROM BASELINE TO 6 MONTHS WAS GREATER IN WHITE PATIENTS (MEDIAN: +20.0, INTERQUARTILE RANGE, 5.0¿40.0 VERSUS +25.0, INTERQUARTILE RANGE, 10.0¿45.0; P0.0298).

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿IMPACT OF RACE ON CLINICAL OUTCOMES AFTER IMPLANTATION WITH A FULLY MAGNETICALLY LEVITATED LEFT VENTRICULAR ASSIST DEVICE: AN ANALYSIS FROM THE MOMENTUM 3 TRIAL¿ THAT THE HEARTMATE 3 (HM3) MAY BE RELATED TO HIGHER MORBIDITY BURDEN, RISK OF STROKE, BLEEDING AND SMALLER GAINS IN FUNCTIONAL CAPACITY AND QUALITY OF LIFE IN BLACK PATIENTS, BUT NO DIFFERENCE WAS OBSERVED FOR MAJOR INFECTION (INCLUDING DRIVELINE INFECTION, RIGHT HEART FAILURE, PUMP THROMBOSIS. A TOTAL OF 960 HM3 PATIENTS ((B)(6): 675, (B)(6): 285) WERE INCLUDED IN THIS RETROSPECTIVITY STUDY WITH CLINICAL EVENTS COMPLETED AS OF (B)(6) 2020. THE MAIN RESULTS WERE AS DESCRIBED: BLACK PATIENTS WERE AT HIGHER RISK OF ADVERSE EVENTS (CALCULATED AS EVENTS PER 100 PATIENT (B)(6)), INCLUDING BLEEDING (75.4 VERSUS 63.5; P0.0001), STROKE (9.5 VERSUS 7.2; P0.0183), AND HYPERTENSION (10.1 VERSUS 3.2; P0.0001). THE 6-MINUTE WALK DISTANCE WAS NOT DIFFERENT AT BASELINE AND 6 MONTHS BETWEEN THE GROUPS, HOWEVER, THE ABSOLUTE CHANGE FROM BASELINE WAS GREATER FOR WHITE PATIENTS (MEDIAN: +183.0, INTERQUARTILE RANGE, 42.0 335.3 ,VERSUS +163.8, INTERQUARTILE RANGE, 42.3 315.0 METERS, P0.01). THE ABSOLUTE QUALITY OF LIFE MEASUREMENT (EUROQOL GROUP, 5-DIMENSION, 5-LEVEL INSTRUMENT VISUAL ANALOG SCALE) AT BASELINE AND 6 MONTHS WAS BETTER IN THE BLACK PATIENT GROUP, BUT RELATIVE IMPROVEMENT FROM BASELINE TO 6 MONTHS WAS GREATER IN WHITE PATIENTS (MEDIAN: +20.0, INTERQUARTILE RANGE, 5.0¿40.0 VERSUS +25.0, INTERQUARTILE RANGE, 10.0¿45.0; P0.0298).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866530 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization