BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4223239 · Received October 27, 2014

    Report

    Report Number
    2916596-2014-01775
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 29, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS DISPOSED OF. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORT OF THROMBUS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. A FULL ANALYSIS OF THE DEVICE COULD NOT BE CONDUCTED AND A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED, BECAUSE (B)(4) WAS NOT RETURNED. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED FROM HOME WITH A NEUROLOGICAL EVENT/MENTAL STATUS CHANGES (EMBOLIC). THE PATIENT'S LDH WAS INCREASED, TRANSIENT HIGH POWERS, HEART FAILURE SYMPTOMS, AND A RAMP STUDY WAS CONSISTENT WITH THROMBOSIS. THE PATIENT RECEIVED A PUMP EXCHANGE. A CLOT IN THE OUTFLOW WAS CONFIRMED. THERE WAS SOME ACCOMPANIED KINKING OF THE OUTFLOW GRAFT, THE PUMP WAS DISPOSED OF AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: LOW PI'S DESPITE MANIPULATION OF RPM'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681077 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 141449

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention