BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9503604 · Received December 20, 2019

    Report

    Report Number
    2916596-2019-05997
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    November 25, 2019
    Report Date
    March 25, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ELEVATED LDH COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON (B)(6) AND NO ADDITIONAL EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) REMAINED ELEVATED BUT STABLE. DISCHARGED WITH LDH OF 449 U/L. THE PATIENT WAS FOUND TO BE A NON-RESPONDER TO PLAVIX AND WAS TRANSITIONED TO DIPYRIDAMOLE FOR DISCHARGE AND WAS BRIDGED WITH HEPARIN UNTIL INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC FOR DISCHARGE. LDH HAS SINCE BEEN ON A STEADY DECLINE, MOST RECENT LDH 294 U/L. WE INCREASED LDH THRESHOLD FOR READMISSION TO 750 U/L.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. 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 WAS ADMITTED ON (B)(6) 2019 FOR ELEVATED LACTATE DEHYDROGENASE (LDH) 564 U/L WITH INTERNATIONAL NORMALIZED RATIO (INR) OF 2.8. THE PATIENT¿S NEW INR GOAL IS 2.5 TO 3.5 AND CURRENTLY BEING TREATED WITH HEPARIN, INTEGRILIN AND PLAVIX. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299325 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 5954426 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R