BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9682013 · Received February 7, 2020

    Report

    Report Number
    2916596-2020-00683
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 16, 2018
    Report Date
    May 12, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED THROMBUS COULD NOT BE DETERMINED. THE PATIENT REMAINED ONGOING ON SUPPORT FROM VAD-62906 UNTIL 25JUN2019 WHEN THEY UNDERWENT A PUMP EXCHANGE (ADDRESSED IN MFR # 2916596-2019-03106). THE PATIENT REMAINED ONGOING ON SUPPORT FROM MLP-013262. PERIPHERAL THROMBOEMBOLIC EVENT IS LISTED IN THE HEARTMATE II IFU AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION LISTS THROMBOEMBOLISM AS A POTENTIAL LATE POST-IMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS SECTION ALSO CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION E2, E3: CORRECTED INFORMATION. SECTION A4: ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT PROVIDED. 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 THAT THE PATIENT HAD A NON-OCCLUSIVE THROMBUS IN THE RIGHT INTERNAL JUGULAR VEIN, WITH A REPEATED ULTRASOUND THE THROMBUS WAS RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145204 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6095658 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention