BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3830706 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00614
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 8, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. DEVICE THROMBOSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PUMP WOULD NOT BE RETURNING FOR INVESTIGATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. 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 SIGNS OF HEMOLYSIS WITH MULTIPLE LACTATE DEHYDROGENASE (LDH) LEVELS GREATER THAN 800 BEGINNING IN (B)(6), NEW ONSET OF CONGESTIVE HEART FAILURE SYMPTOMS, AND TEA-COLORED URINE. HE HAD A PREVIOUS HISTORY OF THROMBUS X2 WITH SUBSEQUENT EXCHANGES. HIS INR WAS 1.8 AT THE TIME OF INITIAL LDH RISE WITH A GOAL OF 2-3. THE PATIENT WAS HOSPITALIZED AND HEPARINIZED WITH SOME IMPROVEMENT. A RAMP STUDY WAS ALSO COMPLETED AND (B)(6). HE WAS DISCHARGED WITH EFFIENT, ASA, AND WARFARIN WITH A GOAL OF 2-3. HIS LDH BECAME ELEVATED AGAIN AND HE WAS TAKEN TO THE OR FOR A PUMP EXCHANGE IN (B)(6) 2014, BUT THE CASE WAS ABORTED DUE TO SEVERE AI ON TEE. NO COAGULOPATHY ISSUES HAVE BEEN IDENTIFIED. NO LOG FILES ARE AVAILABLE.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PT RECEIVED A PUMP EXCHANGE DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270988 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122809

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention