BEUDAMED
    FDA Adverse Event Death Summary report: N

    HRO VASCUALR ACCESS DEVICE

    MDR report key: 2629632 · Received June 21, 2012

    Report

    Report Number
    3006945290-2012-00008
    Event Type
    Death
    Date Received
    June 21, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 25, 2012
    Manufacturer
    HEMOSPHERE INC.
    Product Code
    DSY
    PMA / PMN Number
    K091491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS VIA DIFFERENT METHODS OF COMMUNICATION HAVE BEEN UNSUCCESSFUL TO GET ADDITIONAL DETAILS FROM THE INITIAL REPORTING HEALTH CARE PROFESSIONAL. THE DEVICE WAS NOT RETURNED. IT IS UNKNOWN IF AUTOPSY WAS PERFORMED. THERE IS NO INFORMATION ABOUT WHETHER ANY THROMBECTOMY TECHNIQUES WERE PERFORMED ON THE CLOTTED HERO GRAFT PRIOR TO THE PULMONARY EMBOLUS AND DEATH. SINCE NO PATIENT INFORMATION WAS OBTAINED AND NO AUTOPSY REPORT RECEIVED, THE RELATIONSHIP OF THE DEATH TO THE HERO GRAFT CANNOT BE DETERMINED. AS WITH ALL ESRD PATIENTS, THIS PATIENT WAS AT HIGH RISK FOR ANY NUMBER OF SUDDEN DEATH EVENTS. EMBOLISM IS LISTED IN OUR INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL COMPLICATION. WE PROVIDE GUIDANCE FOR PREVENTING PULMONARY EMBOLISM IN THE IFU AND GUIDELINES ON OUR WEBSITE. WE MONITOR REPORTS OF PULMONARY EMBOLISM THROUGH OUR COMPLAINT HANDLING SYSTEM, AND TO DATE THE TRENDING RATE ((B)(4)) REMAINS CONSIDERABLY LOWER THAN RATES ((B)(4)) NOTED IN OUR CLINICAL STUDIES AND LABELING WHICH ARE COMPARABLE TO THE RATE ((B)(4)) REPORTED IN AN ARTICLE FOR END STAGE RENAL DISEASE PATIENTS. A COMPREHENSIVE LITERATURE REVIEW SHOWED AN AVERAGE PE RATE OF (B)(4) PERCENT FOR ESRD PATIENTS. (B)(4).

    Description of Event or Problem · 1

    REPORT FROM A STATE OWNED,LONG TERM CARE FACILITY,OF A PATIENT DEATH DUE TO PULMONARY EMBOLISM (B)(6 MONTHS AFTER HERO GRAFT IMPLANT. PATIENT CONTINUED USING TUNNELED DIALYSIS CATHETER AFTER HERO GRAFT IMPLANT ON (B)(6) 2012. HERO GRAFT WAS FIRST CANNULATED ON (B)(6) 2012 AND NOTED TO BE CLOTTED ON (B)(6) 2012. PATIENT REFUSED TO HAVE DECLOT PERFORMED AND CONTINUED TO USE TUNNELED DIALYSIS CATHETER FOR DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRO VASCUALR ACCESS DEVICE DSY, LJS, MSD DSY HEMOSPHERE INC. HERO 1001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death TUNNELED DIALYSIS CATHETER