BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2010879 · Received March 3, 2011

    Report

    Report Number
    2916596-2011-00089
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD. THE REPORTED EVENT OF THE INFLOW CONDUIT COLLAPSING DUE TO SWELLING OF THE PRECLOTTING AGENT COSEAL CAN BE CONFIRMED. EXAMINATION OF THE GRAFT CONDUIT FOUND THAT THE POLYESTER GRAFT HAD BUCKLED INWARD ON FOUR SIDES ON THE DISTAL SIDE OF THE TITANIUM RING. THE FLOW PATH RESULTING FROM THE BUCKLED GRAFT WOULD HAVE OBSTRUCTED BLOOD FLOW TO THE PUMP. THE BUCKLING APPEARED TO BE A RESULT OF THE COSEAL SWELLING INSIDE THE GRAFT CONDUIT AFTER THE PUMP HAD BEEN IMPLANTED. THE CURRENT DEVICE LABELING HAS THE FOLLOWING CAUTION STATEMENT: CAUTION! IF A REACT-IN-PLACE SEALANT IS USED, SPECIAL CARE MUST BE TAKEN TO DELIVER THE SEALANT INTO THIS SPACE BEFORE REACTION IS COMPLETE. PLEASE REFER TO THE REACT-IN-PLACE SEALANT'S INSTRUCTIONS FOR USE PRIOR TO INITIATING PRE-CLOTTING, AS EXCESS SEALANT CAN COLLAPSE THE GRAFT AND RESTRICT FLOW. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING SYMPTOMS OF THROMBUS THREE WEEKS AFTER IMPLANT. SUBSEQUENTLY THE PT RECEIVED A PUMP EXCHANGE AND SMALL THROMBUS NOTED, BUT INFLOW CONDUIT APPEARED CLOSED OFF POTENTIALLY DUE TO PRE CLOTTING AGENT OF COSEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100283

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention