BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO GRAFT

    MDR report key: 5035483 · Received August 27, 2015

    Report

    Report Number
    1063481-2015-00162
    Event Type
    Death
    Date Received
    August 27, 2015
    Report Date
    July 30, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K124039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION, "PROSPECTIVE ANALYSIS OF HEMODIALYSIS RELIABLE OUTFLOW VASCULAR ACCESS GRAFT VS. CUFFED CATHETER ACCESS IN HEMODIALYSIS," THE PROSPECTIVE COHORT STUDY ASSESSED CLINICAL OUTCOMES IN 16 HERO GRAFT PATIENTS AGAINST A CONTROL GROUP WITHOUT HERO (N=17) OVER ONE YEAR. THE ADVERSE EVENTS ASSOCIATED WITH EACH PATIENT ARE BEING REPORTED COLLECTIVELY PER PATIENT AS A DETERMINATION COULD NOT BE MADE REGARDING THE RELATION OF THE ASSOCIATED EVENTS. FURTHERMORE, THE SPECIFIC PATIENT COMORBIDITIES AND CONTRIBUTORY FACTORS FOR THE REPORTED ADVERSE EVENTS CANNOT BE CORRELATED. THE MOST COMMON ETIOLOGY OF END-STAGE RENAL DISEASE (ESRD) WAS DIABETES, HYPERTENSION, OR THE COMBINATION OF BOTH. THE MOST COMMON COMORBIDITIES IN BOTH STUDY GROUPS WERE DIABETES MELLITUS, HYPERTENSION, AND MYOCARDIAL INFARCTION. THIS MEDWATCH IS BEING SUBMITTED AS PRODUCT CODE HERO 1001, HOWEVER THE SCOPE OF THE INVESTIGATION WILL EVALUATE BOTH HERO 1001 AND HERO 1002 COMPONENTS. THIS REPORT IS BEING SUBMITTED FOR (B)(6). (B)(6) WAS A MALE WHO RECEIVED A HERO IMPLANT ON (B)(6) 2012 AND WAS TREATED ON(B)(6) 2012 WITH AN ANGIOPLASTY FOR A MALFUNCTIONING IJ PERMCATH. THE PATIENT DIED ON (B)(6) 2013 HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME REGARDING THE CAUSE OF DEATH. THE MANUFACTURING RECORDS FOR LOT 0001530 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. (B)(6) HAD A HERO GRAFT IMPLANTED ON (B)(6) 2012. THE PATIENT DIED ON (B)(6) 2013 AND THE CAUSE OF DEATH IS UNKNOWN. ALTHOUGH THE CAUSE OF DEATH IS UNKNOWN, THE AUTHORS DID NOT BELIEVE THE DEATH WAS HERO-RELATED. HOWEVER, DEATH IS LISTED IN THE HERO GRAFT IFU AS A POTENTIAL INTRAOPERATIVE AND POST-OPERATIVE COMPLICATION. THE SPECIFIC RELATIONSHIP BETWEEN THE HERO GRAFT AND THE PATIENT DEATH CANNOT BE ASSESSED AT THIS TIME BASED ON THE LIMITED AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, "PROSPECTIVE ANALYSIS OF HEMODIALYSIS RELIABLE OUTFLOW VASCULAR ACCESS GRAFT VS. CUFFED CATHETER ACCESS IN HEMODIALYSIS," THE PROSPECTIVE COHORT STUDY ASSESSED CLINICAL OUTCOMES IN 16 HERO GRAFT PATIENTS AGAINST A CONTROL GROUP WITHOUT HERO (N=17) OVER ONE YEAR. THE ADVERSE EVENTS ASSOCIATED WITH EACH PATIENT ARE BEING REPORTED COLLECTIVELY PER PATIENT AS A DETERMINATION COULD NOT BE MADE REGARDING THE RELATION OF THE ASSOCIATED EVENTS. FURTHERMORE, THE SPECIFIC PATIENT COMORBIDITIES AND CONTRIBUTORY FACTORS FOR THE REPORTED ADVERSE EVENTS CANNOT BE CORRELATED. THE MOST COMMON ETIOLOGY OF END-STAGE RENAL DISEASE (ESRD) WAS DIABETES, HYPERTENSION, OR THE COMBINATION OF BOTH. THE MOST COMMON COMORBIDITIES IN BOTH STUDY GROUPS WERE DIABETES MELLITUS, HYPERTENSION, AND MYOCARDIAL INFARCTION. THIS MEDWATCH IS BEING SUBMITTED AS PRODUCT CODE HERO 1001, HOWEVER THE SCOPE OF THE INVESTIGATION WILL EVALUATE BOTH HERO 1001 AND HERO 1002 COMPONENTS. THIS REPORT IS BEING SUBMITTED FOR (B)(6). (B)(6) WAS A MALE WHO RECEIVED A HERO IMPLANT ON(B)(6) 2012 AND WAS TREATED ON (B)(6) 2012 WITH AN ANGIOPLASTY FOR A MALFUNCTIONING IJ PERMCATH. THE PATIENT DIED ON (B)(6) 2013 HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME REGARDING THE CAUSE OF DEATH.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, "PROSPECTIVE ANALYSIS OF HEMODIALYSIS RELIABLE OUTFLOW VASCULAR ACCESS GRAFT VS. CUFFED CATHETER ACCESS IN HEMODIALYSIS," THE PROSPECTIVE COHORT STUDY ASSESSED CLINICAL OUTCOMES IN 16 HERO GRAFT PATIENTS AGAINST A CONTROL GROUP WITHOUT HERO (N=17) OVER ONE YEAR. THE ADVERSE EVENTS ASSOCIATED WITH EACH PATIENT ARE BEING REPORTED COLLECTIVELY PER PATIENT AS A DETERMINATION COULD NOT BE MADE REGARDING THE RELATION OF THE ASSOCIATED EVENTS. FURTHERMORE, THE SPECIFIC PATIENT COMORBIDITIES AND CONTRIBUTORY FACTORS FOR THE REPORTED ADVERSE EVENTS CANNOT BE CORRELATED. THE MOST COMMON ETIOLOGY OF END-STAGE RENAL DISEASE (ESRD) WAS DIABETES, HYPERTENSION, OR THE COMBINATION OF BOTH. THE MOST COMMON COMORBIDITIES IN BOTH STUDY GROUPS WERE DIABETES MELLITUS, HYPERTENSION, AND MYOCARDIAL INFARCTION. THIS MEDWATCH IS BEING SUBMITTED AS PRODUCT CODE HERO 1001, HOWEVER THE SCOPE OF THE INVESTIGATION WILL EVALUATE BOTH HERO 1001 AND HERO 1002 COMPONENTS. THIS REPORT IS BEING SUBMITTED FOR PATIENT 030. PATIENT 030 WAS A MALE WHO RECEIVED A HERO IMPLANT ON (B)(6) 2012 AND WAS TREATED ON (B)(6) 2012 WITH AN ANGIOPLASTY FOR A MALFUNCTIONING IJ PERMCATH. THE PATIENT DIED ON (B)(6) 2013 HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME REGARDING THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568491 HERO GRAFT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 1001 0001530

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H