BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3202066 · Received June 27, 2013

    Report

    Report Number
    2916596-2013-00817
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 31, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-2/24/12-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A SEALED OUTFLOW GRAFT BEND RELIEF DISCONNECT COULD NOT BE CONFIRMED BY THE MFR AS THE PUMP IS STILL IN USE SUPPORTING THE PATIENT. THERE WERE NO REPORTED ISSUES FROM THE HOSPITAL REGARDING THE CONNECTION OF THE SEALED OUTFLOW GRAFT BEND RELIEF AT IMPLANT. X-RAYS IMAGES WERE NOT PROVIDED TO THE MFR. THE HOSPITAL REPORTED THAT AN OUTFLOW GRAFT BEND RELIEF COLLAR WAS PLACED ONTO THE SEALED OUTFLOW GRAFT BEND RELIEF TO REPAIR THE DISCONNECT. THE PATIENT REMAINS ON-GOING ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED TO THE MFR. THESE REPORTS OF DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT HAVE BEEN ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM, UPDATED DEVICE LABELING, AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596-2/24/12-001-C) AND A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR) USED TO SECURE THE BEND RELIEF TO THE SEALED OUTFLOW GRAFT AND INCREASE THE ASSEMBLY'S RESISTANCE TO FORCES THAT WOULD TEND TO DISLODGE THE BEND RELIEF. THIS DESIGN MODIFICATION WAS APPROVED IN A PMA SUPPLEMENT AND HAS BEEN IMPLEMENTED. (B)(4). A REVIEW OF DEVICE HISTORY RECORDS FOR THE RETURNED DEVICES SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED A USER FACILITY REPORT FROM THE INTERMACS REGISTRY STATING THAT X-RAY IMAGES DEMONSTRATED A DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT. THE PATIENT WAS ADMITTED FOR OPERATIVE REPAIR OF THE DISCONNECT. THE PROCEDURE WAS PERFORMED BY IMPLANTATION OF A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293024 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108215

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention