BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 4826339 · Received June 9, 2015

    Report

    Report Number
    1063481-2015-00084
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    September 17, 2010
    Report Date
    June 1, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K124039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION, "EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION," A TOTAL OF 11 PATIENTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PATIENTS HAD CARDIOVASCULAR OCCLUSIVE DISEASE (CVOD) TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PATIENTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND ARTERIOVENOUS [AV] FISTULAS OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PATIENTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR RE-INTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3), PSEUDOANEURYSM (TOTAL OF 2 EVENTS), BACTEREMIA (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFORMATION "GRAFTS REMOVED DUE TO ABSCESS FORMATION OVER GRAFT." THIS MEDWATCH REPRESENTS 1 SEROMA EVENT. BOTH HERO 1001 AND HERO 1002 WERE INVESTIGATED AS IT COULD NOT BE DETERMINED WHICH COMPONENT, IF EITHER CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS PROVIDED FROM THE SURGEON AND IT WAS DETERMINED THAT THIS EVENT REPRESENTS PATIENT 2 IN THE STUDY. PATIENT 2 WAS A MALE WHO HAD A HERO GRAFT (HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186) IMPLANTED ON (B)(6) 2010. THE PATIENT HAS HAD MULTIPLE COMPLICATIONS INCLUDING THROMBOSIS, PSEUDOANEURYSM, BACTEREMIA, SEROMA, AND HEMATOMA. BACTEREMIA WAS IDENTIFIED ON (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING BACTEREMIA. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI HOWEVER, URINE CULTURE RESULTS NO GROWTH. A SECOND BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS NOT CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. A THIRD BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. TWO SEROMAS WERE IDENTIFIED IN THE PATIENT ON (B)(6) 2010 AND (B)(6) 2011; BOTH SEROMAS WERE LOCATED NEAR RIGHT UPPER EXTREMITY NEAR LOCATION OF ARTERIAL ANASTOMOSIS. THREE HEMATOMAS WERE IDENTIFIED ON (B)(6) 2010, (B)(6) 2014 AND (B)(6) 2015. THE HEMATOMAS OCCURRED IN THE RIGHT UPPER EXTREMITY AROUND ARTERIAL END OF GRAFT, IN THE RIGHT UPPER EXTREMITY NEAR ARTERIAL ANASTOMOSIS BUT DID NOT INVOLVE GRAFT, AND IN THE RIGHT UPPER EXTREMITY AROUND DISTAL THIRD OF GRAFT SEGMENT. A MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT OCCURRED ON (B)(6) 2014 FOR THROMBOSIS. PSEUDOANEURYSMS WERE IDENTIFIED ON (B)(6) 2014, (B)(6) 2015, DURING ALL THREE OF WHICH THE HERO WAS CANNULATED DURING. EACH EVENT WHICH OCCURRED IN PATIENT 5 IS SUBMITTED IN A SEPARATE MEDWATCH. THIS MEDWATCH REPRESENTS THE SEROMA IDENTIFIED ON (B)(6) 2010. THE MANUFACTURING RECORDS FOR LOTS HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE IFU ALSO LISTS PSEUDOANEURYSM AND SEROMAS AS POTENTIAL VASCULAR GRAFT AND CATHETER COMPLICATIONS. FOUR SEROMA CASES WERE REPORTED IN 2 PATIENTS. TWO PATIENTS HAD MULTIPLE SEROMAS. SEROMA IS A KNOWN EARLY COMPLICATION OF EXPANDED POLYTETRAFLUOROETHYLENE GRAFTS. PATIENT MEDICAL HISTORY IS UNKNOWN. AT THIS TIME, THE ROLE OF THE HERO GRAFT IN THESE COMPLICATIONS CANNOT BE DETERMINED DUE TO THE AFOREMENTIONED UNKNOWNS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN; HOWEVER, ALL COMPLICATIONS NOTED IN THE COMPLAINT ARE KNOWN POTENTIAL COMPLICATION OF THE HERO GRAFT. THE IFU LISTS THE FOLLOWING POTENTIAL COMPLICATIONS WITH THE USE OF THE HERO GRAFT: SEROMA, INFECTION, VASCULAR GRAFT REVISION/REPLACEMENT, PARTIAL STENOSIS OR FULL OCCLUSION OF PROSTHESIS OR VASCULATURE, PSEUDOANEURYSM, HEMATOMA, AND ABNORMAL HEALING. THE HERO GRAFT IS UNLIKELY TO BE THE DIRECT SOURCE OF THE INFECTION AS THE PRODUCT UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES RISK.

    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, EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION, A TOTAL OF 11 PATIENTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PATIENTS HAD CVOD TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PATIENTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND AV FISTULAS OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PATIENTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR REINTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3), PSEUDOANEURYSM (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFORMATION "GRAFTS REMOVED DUE TO ABCESS FORMATION OVER GRAFT." THIS MEDWATCH IS BEING SUBMITTED FOR THE SEROMA EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION, A TOTAL OF 11 PATIENTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PATIENTS HAD CVOD TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PATIENTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND AV FISTULASD OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PATIENTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR REINTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3), PSEUDOANEURYSM (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFORMATION "GRAFTS REMOVED DUE TO ABCESS FORMATION OVER GRAFT." THIS MEDWATCH IS BEING SUBMITTED FOR THE SEROMA EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370156 HERO GRAFT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 1001 0001184

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R