BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8984118 · Received September 10, 2019

    Report

    Report Number
    2916596-2019-04380
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    April 1, 2019
    Report Date
    November 27, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT OF PUMP THROMBOSIS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. IN ADDITION, A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTION COULD NOT BE DETERMINED. FURTHERMORE, A DIRECT CORRELATION BETWEEN THE IMPLANTED HEARTMATE 3 DEVICES AND THE REPORTED EVENTS OF GI BLEEDING, EARLY/LATE RIGHT HEART FAILURE, AND STROKE COULD NOT BE ESTABLISHED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿MINIMALLY INVASIVE LVAD IMPLANTATION: EARLY AND MID-TERM RESULTS AT A SINGLE CENTER¿ REPORTED THE FOLLOWING INFORMATION: FROM (B)(6)2015 TO (B)(6)2018, 49 PATIENTS UNDERWENT LVAD IMPLANTATION AT A SINGLE CENTER. OF THE 49 PATIENTS, 17 WERE IMPLANTED WITH A HEARTMATE 3 LVAD, WHILE THE REMAINING 32 PATIENTS WERE IMPLANTED WITH HEARTWARE (HVAD). RESULTS OF THE STUDY REVEALED THAT THE MOST COMMON ADVERSE EVENT WHILE PATIENTS WERE SUPPORTED BY THE DEVICES WAS DRIVELINE INFECTION (18.3%). 2% OF THE PATIENTS HAD GASTROINTESTINAL BLEEDING, 8% EXPERIENCED HEMORRHAGIC CEREBROVASCULAR EVENTS, 10.2% HAD PUMP THROMBOSIS, 10.1% HAD EARLY RIGHT VENTRICLE FAILURE, AND 5% HAD LATE RIGHT VENTRICLE FAILURE. ELEVEN PATIENTS WERE ULTIMATELY TRANSPLANTED. THE STUDY CONCLUDED THAT MINIMALLY INVASIVE IMPLANTATION OF BOTH LVADS WAS SAFELY FEASIBLE. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND SPECIFIC CASE/PATIENT INFORMATION WAS NOT AVAILABLE. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING, DRIVELINE INFECTION, RIGHT HEART FAILURE, STROKE, AND PUMP THROMBOSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT HAS BEEN ENTERED AS THE SAME AS THE PUBLISHED DATE OF THE ABSTRACT ((B)(6) 2019) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. THE AUTHOR OF THE ABSTRACT IS U. KERVAN ET AL. CARDIOLOGY, CARDIOVASCULAR SURGERY, TURKEY YUKSEK IHTISAS HOSPITAL, ANKARA, TURKEY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT TITLED ¿MINIMALLY INVASIVE LVAD IMPLANTATION: EARLY AND MID-TERM RESULTS AT A SINGLE CENTER¿ THAT HEARTMATE 3 WAS IDENTIFIED AS POSSIBLY RELATED TO EARLY RIGHT VENTRICULAR FAILURE, DRIVELINE INFECTION, GASTROINTESTINAL BLEEDING, HEMORRHAGIC CEREBROVASCULAR EVENT, PUMP THROMBOSIS, AND LATE RIGHT VENTRICULAR FAILURE. THE DEVICE WAS IMPLANTED AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775983 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Other