BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 3946101 · Received July 21, 2014

    Report

    Report Number
    3006945290-2014-00052
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    June 19, 2014
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, THE PATIENT DEVELOPED STEAL SYNDROME 3 MONTHS AFTER IMPLANTATION. HERO ACCESS WAS ABANDONED. THE MANUFACTURING RECORDS FOR LOT # 0001499 (HERO 1002) WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE HERO GRAFT INSTRUCTIONS FOR USE (IFU) LISTS VASCULAR INSUFFICIENCY DUE TO STEAL SYNDROME AS A POTENTIAL COMPLICATION. TABLE 2 OF THE IFU SHOWS STEAL SYNDROME FOR HERO RANGING FROM 2.6% TO 3.8%, AND 3.8% IN AVG. GAGE, ET. AL. (2012) REPORTED STEAL SYNDROME IN 1.4% OF THEIR SERIES. THEY SPECULATED "THE LOW OBSERVED CLINICALLY SIGNIFICANT STEAL RATE IS A FUNCTION OF THE INTRINSIC HEMODYNAMICS OF THE DEVICE WHERE BOTH THE LENGTH OF THE DEVICE (ROUGHLY TWICE THE LENGTH OF CONVENTIONAL GRAFTS) AND THE DIAMETER (5 MM ID OUTFLOW COMPONENT) CONTRIBUTE TO REDUCE THE FLOW AND PRESERVE PERFUSION TO THE HAND." STEAL SYNDROME IS NOT UNIQUE TO HERO GRAFT; THE IFU PROVIDES INFORMATION TO PREVENT STEAL SYNDROME AFTER IMPLANT. THE IFU'S PATIENT SELECTION CONSIDERATIONS STATES THE TARGET ARTERY MUST HAVE AN INNER DIAMETER (ID) OF AT LEAST 3MM TO PROVIDE ADEQUATE ARTERIAL INFLOW TO SUPPORT THE 6 MM EPTFE GRAFT. AT THE END OF THE IMPLANT INSTRUCTIONS FOR THE ARTERIAL GRAFT COMPONENT AND ARTERY CONNECTIONS THE IFU STATES: "EVALUATE FOR STEAL SYNDROME DURING THE IMPLANT PROCEDURE WITH DOPPLER OF THE RADIAL AND ULNAR ARTERIES. IF STEAL SYNDROME SYMPTOMS OCCUR, CONSIDER SURGICAL INTERVENTIONS SUCH AS: DRIL (DISTAL REVASCULARIZATION-INTERVAL LIGATION) PROCEDURE. BANDING, THOUGH THIS MAY REDUCE THE FLOW IN THE HERO GRAFT. PROXIMALIZATION OF THE INFLOW". THIS EVENT REPRESENTS KNOWN POTENTIAL COMPLICATIONS OF THE HERO GRAFT WHICH ARE OUTLINED IN THE DEVICE'S IFU. THESE KNOWN POTENTIAL COMPLICATIONS ARE COMMON AMONG ALL ARTERIOVENOUS GRAFTS, AND DO NOT SUGGEST THAT THERE IS A DEFICIENCY IN THE HERO OR THE HERO IFU. THERE IS NO EVIDENCE TO SUGGEST THAT AN ERROR OCCURRED IN PROCESSING OR PRODUCTION. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES RISKS.

    Description of Event or Problem · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, A PATIENT DEVELOPED STEAL SYNDROME AND THE HERO GRAFT WAS ABANDONED.

    Description of Event or Problem · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, A PATIENT DEVELOPED STEAL SYNDROME AND THE HERO GRAFT WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424377 HERO GRAFT VASCULAR GRAFT PROSTHESIS DSY HEMOSPHERE, INC. HERO 1002 0001499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other