BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO GRAFT

    MDR report key: 3013283 · Received March 20, 2013

    Report

    Report Number
    3006945290-2013-00017
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    March 5, 2013
    Report Date
    July 29, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K121532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED IS ACCURATE OR HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE PATIENT EXPIRED TWO DAYS AFTER THE HERO GRAFT (HERO 1001 LOT #: 0001779, HERO 1002 LOT #: 0001834) WAS IMPLANTED. THE DIALYSIS CENTER INDICATED THAT THE PATIENT WAS "EXTREMELY COMPROMISED" AND HAD EXPERIENCED NUMEROUS COMPLICATIONS. THE PATIENT'S MEDICAL HISTORY INCLUDES OBESITY, DIABETES AND END STAGE RENAL DISEASE FOR AT LEAST 4 YEARS. FURTHER REVIEW OF THE EVENT IN QUESTION REVEALED THAT THE PATIENT WAS A (B)(6) WITH END-STAGE RENAL DISEASE SECONDARY TO DIABETIC NEPHROPATHY. THE PATIENT WAS ADMITTED ON (B)(6) 2013 AND PRESENTED WITH MULTIPLE COMORBIDITIES INCLUDING COAGULOPATHY, A-FIB, HEART BLOCK WITH PACEMAKER, AND PARTIAL FOOT AMPUTATION. THE PATIENT WAS NOTED TO HAVE A COMPLEX WOUND INFECTION OF THE RIGHT FOOT; WHEN CULTURED, (B)(6) WAS FOUND. NUMEROUS NECROTIC PRESSURE ULCERS WERE ALSO NOTED ON HER TRUNK AND EXTREMITIES. THE HERO GRAFT WAS SUCCESSFULLY PLACED IN A RIGHT BRACHIAL ARTERY TO RIGHT AXILLARY VEIN POSITION ON (B)(6) 2013. THE PATIENT CODED ON (B)(6) 2013 AND WAS UNABLE TO BE RESUSCITATED. THE TREATING PHYSICIAN DOCUMENTED THE CAUSE OF DEATH AS SEPTIC SHOCK, ACUTE RESPIRATORY FAILURE, HYPOGLYCEMIA, AND END-STAGE RENAL DISEASE. NO ADVERSE EVENT INVOLVING THE HERO GRAFT IS NOTED IN THE MEDICAL RECORD. THE AVAILABLE MEDICAL RECORDS INDICATE THAT THE PATIENT WAS IN AN EXTREMELY COMPROMISED STATE AT THE TIME OF THE HERO IMPLANT. NO AUTOPSY WAS PERFORMED, SO THE CAUSE OF PATIENT DEATH CANNOT BE CONFIRMED. HOWEVER, THE PATIENT'S MEDICAL CONDITIONS WERE COMPLICATED BY SEPTIC SHOCK RESULTING FROM A COMPLEX WOUND INFECTION IN THE RIGHT FOOT AND THE PATIENT'S MULTIPLE CO-MORBIDITIES COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH; THESE INCLUDE HEART DISEASE, INFECTION, PNEUMONIA, DIABETES, END STAGE RENAL DISEASE, AND CALCIPHYLAXIS. THERE IS NO INFORMATION IN THE MEDICAL RECORD TO SUGGEST THAT A COMPLICATION RELATED TO THE HERO GRAFT CONTRIBUTED TO THE PATIENT'S DEATH IN ANY WAY. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. THE DEVICE HISTORY RECORDS FOR LOTS 0001779 AND 0001834 WERE REVIEWED BY QUALITY AND CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL PHYSICAL, FUNCTIONAL, MICROBIAL, AND CHEMICAL SPECIFICATIONS PER THE HEMOSPHERE DEVICE MASTER RECORDS - (B)(4). THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED IS ACCURATE OR HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT EXPIRED TWO DAYS AFTER THE HERO GRAFT WAS IMPLANTED. THE DIALYSIS CENTER INDICATED THAT THE PATIENT WAS "EXTREMELY COMPROMISED" AND HAS HAD NUMEROUS COMPLICATIONS. THE PATIENT'S MEDICAL HISTORY INCLUDES OBESITY, DIABETES, AND END STAGE RENAL DISEASE FOR AT LEAST FOUR YEARS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT EXPIRED TWO DAYS AFTER THE HERO GRAFT WAS IMPLANTED. THE DIALYSIS CENTER INDICATED THAT THE PATIENT WAS "EXTREMELY COMPROMISED" AND HAS HAD NUMEROUS COMPLICATIONS. THE PATIENT'S MEDICAL HISTORY INCLUDES OBESITY, DIABETES, AND END STAGE RENAL DISEASE FOR AT LEAST FOUR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115661 HERO GRAFT VASCULAR GRAFT - PROSTHESIS DSY HEMOSPHERE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 DA Death