BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HM II LVAS EUROPE

    MDR report key: 1924876 · Received December 9, 2010

    Report

    Report Number
    2916596-2010-00328
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2.5 YEARS POST-IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS AT HOME AND CALLED THE HOSPITAL TO REPORT OBSERVING SOME TEARS IN THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD, WHERE HE NOTICED DRAINAGE OF SEROUS FLUID. THE PATIENT WAS READMITTED TO THE HOSPITAL SO THAT THE AREA COULD BE EXAMINED AND THE PATIENT COULD BE CLOSELY MONITORED. SINCE IMPLANT, THE PATIENT HAD A MASSIVE GAIN IN WEIGHT AND A RUPTURE OF THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD WAS SUSPECTED. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, BUT REVEALED NO OBVIOUS DAMAGE. A DECISION WAS MADE TO EXCHANGE THE PUMP TO PREVENT POSSIBLE RUPTURE TO THE PERCUTANEOUS LEAD. ONCE EXPLANTED, THE VAD TEAM NOTICED DAMAGE TO THE BEND RELIEF OF THE PERCUTANEOUS LEAD AT THE PUMP HOUSING AND BELIEVES THAT THE PATIENT'S WEIGHT GAIN WAS THE MOST LIKELY REASON FOR THE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DSQ THORATEC CORPORATION 102139

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention