BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO VASCULAR ACCESS DEVICE

    MDR report key: 2306081 · Received October 19, 2011

    Report

    Report Number
    3006945290-2011-00007
    Event Type
    Death
    Date Received
    October 19, 2011
    Report Date
    October 18, 2011
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K091491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. ATTEMPTS TO GET A COPY OF THE AUTOPSY REPORT WERE UNSUCCESSFUL. ACCORDING TO THE REPORTING PHYSICIAN, THE HERO WAS NOT THE DIRECT CAUSE OF DEATH BUT THERE WAS SUSPICION OF PULMONARY EMBOLISM. 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 AS A POTENTIAL COMPLICATION. WE PROVIDE GUIDANCE FOR PREVENTING PULMONARY EMBOLISM IN TECHNICAL BULLETINS 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 CONDUCTED AT THE TIME OF THE CLINICAL TRIAL SHOWED AN AVERAGE PE RATE OF (B)(4) FOR ESRD PATIENTS. WATTANAKIT K, CUSHMAN M, STEHMAN-BREEN C, HECKBERT S AND FOLSON A. CHRONIC KIDNEY DISEASE INCREASED RISK FOR VENOUS THROMBOEMBOLISM. J AM SOC NEPHROL: 2008; 19:135-140. LUCAS, G. SCIENTIFIC REVIEW OF ADVERSE EVENTS RELATED TO THE USE OF CHRONIC HEMODIALYSIS CATHETERS: 2007; ON FILE AT HEMOSPHERE, INC.

    Description of Event or Problem · 1

    REPORT OF PATIENT DEATH AFTER RECURRENT THROMBOSIS OF HERO. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL AT OBTAINING DETAILS AND COPIES OF PATIENT RECORDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death