BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15486197 · Received September 26, 2022

    Report

    Report Number
    2916596-2022-14126
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    July 1, 2022
    Report Date
    September 28, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE TITLE: HOSPITALIZATION PATTERNS AND IMPACT OF A MAGNETICALLY-LEVITATED LEFT VENTRICULAR ASSIST DEVICE IN THE MOMENTUM 3 TRIAL. VIDULA, HIMABINDU ET AL. JACC: HEART FAILURE 10.7: 470-481. ELSEVIER INC. (JUL 2022) DIVISION OF CARDIOLOGY, UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY, ROCHESTER, NY, UNITED STATES. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 88197). 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 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. A SPECIFIC CAUSE FOR THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. SPECIFIC DEVICE SERIAL NUMBERS WERE NOT PROVIDED, AND NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE APPLICABLE SERIAL/LOT NUMBERS OF THE HEARTMATE 3 LVAD'S (LEFT VENTRICULAR ASSIST DEVICES) ASSOCIATED WITH THE REPORTED EVENTS WERE NOT PROVIDED AND WERE NOT REQUESTED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS LOCALIZED INFECTION, DRIVELINE INFECTION, PUMP POCKET/PSEUDO PUMP POCKET INFECTION, AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION ALSO INCLUDES INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. ADDITIONALLY, SECTION 6 PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION. 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 ¿HOSPITALIZATION PATTERNS AND IMPACT OF A MAGNETICALLY-LEVITATED LEFT VENTRICULAR ASSIST DEVICE IN THE MOMENTUM 3 TRIAL¿ THAT HEARTMATE 3 (HM 3) MAY BE RELATED TO REHOSPITALIZATION. THIS WAS A RETROSPECTIVE STUDY THAT EVALUATED 485 HM3 PATIENTS. IN HM3 RECIPIENTS, THE MOST FREQUENT CAUSES OF REHOSPITALIZATION INCLUDED INFECTION, HEART FAILURE (HF)-RELATED EVENTS, AND BLEEDING. FIRST REHOSPITALIZATION CAUSED BY HF-RELATED EVENTS VERSUS OTHER CAUSES WERE ASSOCIATED WITH REDUCED SURVIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588286 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization