BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO GRAFT

    MDR report key: 4124059 · Received September 27, 2014

    Report

    Report Number
    3006945290-2014-00068
    Event Type
    Death
    Date Received
    September 27, 2014
    Report Date
    March 17, 2014
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION, EXAMINING HERO CATHETER PERFORMANCE AND COST IN HEMODIALYSIS ACCESS, A PATIENT EXPIRED AFTER RECEIVING A HERO IMPLANT. THE TIME PERIOD BETWEEN IMPLANT AND PATIENT EXPIRATION IS UNKNOWN. UPON REVIEW OF THE FILE, IT WAS DECIDED THAT THE COMPLAINT SHOULD ALSO BE INVESTIGATED ALSO AS PRODUCT CODE HERO 1002. A MEDWATCH WAS SUBMITTED FOR THIS EVENT UNDER PRODUCT CODE HERO 1001 REFER TO 3006945290-2014-00031. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. A REVIEW OF THIS EVENT WAS PERFORMED BASED ON THE LIMITED AVAILABLE INFORMATION. A RECORDS REVIEW WAS PERFORMED FOR ALL LOT NUMBERS SHIPPED TO THE HOSPITAL AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS. THE CAUSES OF DEATH AND RELATIONSHIPS TO THE HERO DEVICE ARE UNKNOWN. THE PUBLICATION NOTES THAT THE PATIENTS RECEIVING THE HERO DEVICE HAVE BEEN ON DIALYSIS FOR A MEAN OF 7.8 YEARS AND HAD MULTIPLE COMORBIDITIES INCLUDING HYPERTENSION, DIABETES, OBESITY, AND HYPERLIPIDEMIA, ALL OF WHICH WOULD PLACE THE PATIENTS AT AN INCREASED RISK OF DEATH. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE A ROOT CAUSE OF THE REPORTED EVENT. THE HERO GRAFT INSTRUCTIONS FOR USE LIST DEATH AS A POTENTIAL COMPLICATION.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, EXAMINING HERO CATHETER PERFORMANCE AND COST IN HEMODIALYSIS ACCESS, A PATIENT EXPIRED AFTER RECEIVING A HERO IMPLANT. THE TIME PERIOD BETWEEN IMPLANT AND PATIENT EXPIRATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603363 HERO GRAFT VASCULAR GRAFT DSY HEMOSPHERE, INC. HERO 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 Death