BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERO GRAFT ACCESSORY COMPONENT KIT

    MDR report key: 4936702 · Received July 23, 2015

    Report

    Report Number
    1063481-2015-00126
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K124039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF EVENTS AND EXACT DATES OF AWARENESS ARE UNKNOWN. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE FEEDBACK, A CRYOLIFE REPRESENTATIVE HAS "THREE SURGEONS THAT DO 2-3 HERO GRAFTS A YEAR THAT ARE VERY CONCERNED WITH THE CURRENT SHEATH AND PLUG. THEY CONSIDER IT AN 'EMBOLISM WAITING TO HAPPEN.' PEOPLE LIKE (B)(6) [EXPERIENCED SURGEONS] AREN'T AS CONCERNED BECAUSE THEY KNOW HOW TO POSITION THE PATIENT CORRECTLY, HOLD BREATH, AND HOW TO HANDLE IT IF IT HAPPENS. OTHER SURGEONS MAY NOT BE AS TECHNICALLY SAVVY." ADDITIONAL INFORMATION FROM THE REPRESENTATIVE INDICATED THAT NO EVENTS OF EMBOLISM HAVE OCCURRED WITH THE THREE SURGEONS. ALL THREE OF THE SURGEONS (DR. (B)(6) IN (B)(6) HAVE EXPERIENCED INTERVENTIONAL RADIOLOGISTS WHO GO INTO SURGERY WITH THEM WHO ARE ALL USED TO USING DILATOR WIRES AND SHEATHS WITH VALVES. THE FEEDBACK WAS RECEIVED SOMETIME IN 2012 FOR DR. (B)(6) AND SOMETIME IN 2013 FOR DRS. (B)(6); THE EXACT DATES WERE UNAVAILABLE. A REVIEW OF MANUFACTURING RECORDS WAS NOT REQUESTED FROM QUALITY ASSURANCE/QUALITY CONTROL AS LOT NUMBERS FOR THE HERO DEVICE ARE UNKNOWN. THE DATE OF IMPLANT IS UNKNOWN; THEREFORE, SAP COULD NOT BE QUERIED FOR POSSIBLE LOT NUMBERS SHIPPED TO THE HOSPITAL. A LOT NUMBER QUERY CANNOT BE PERFORMED. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED BY THE CLINICAL DEPARTMENT AND MEDICAL DIRECTORS. THREE SURGEONS ARE CONCERNED ABOUT THE CURRENT HERO SHEATH AND PLUG AND CONSIDER IT "AN EMBOLISM WAITING TO HAPPEN." ALL THREE SURGEONS IMPLANT APPROXIMATELY 2-3 HERO GRAFTS ANNUALLY AND CURRENTLY THEY HAVE NO EMBOLISM EVENTS TO REPORT. DURING HERO GRAFT IMPLANTATION THE SURGEONS ARE ACCOMPANIED BY INTERVENTIONAL RADIOLOGISTS WHO ARE USED TO USING DILATOR WIRES AND VALVED SHEATHS. THE HERO GRAFT INSTRUCTIONS FOR USE (IFU) PROVIDES WRITTEN AND VISUAL INSTRUCTIONS ON HOW TO USE THE SHEATH AND PLUG. THE HERO IFU ALSO LISTS EMBOLISM AS A POTENTIAL INTRAOPERATIVE AND POST-OPERATIVE COMPLICATION; TABLE 2 OF THE IFU SHOWS RATES OF 1.9% - 2.6% FOR PULMONARY EMBOLISM (PE). ADDITIONALLY, THE HERO FREQUENTLY ASKED QUESTIONS (FAQ): EXPLANT, EXCHANGE, REVISION, OR ABANDONMENT DOCUMENT RECOMMENDS PLACING THE PATIENT INTO TRENDELENBURG POSITION TO REDUCE THE POTENTIAL FOR AIR EMBOLUS DURING EXCHANGES; FOR PATIENTS UNDERGOING GENERAL ANESTHESIA, A POSITIVE BREATH CAN BE FORCED DURING REMOVAL OF THE DILATOR FROM THE SHEATH TO PREVENT AIR INDUCTION. AT THIS TIME THERE IS NO EVIDENCE TO SUPPORT AN INCREASED RISK OF EMBOLISM WITH THE RECOMMENDED USE OF THE HERO SHEATH/PLUG. SURGEONS ARE TRAINED ON HOW TO IMPLANT THE HERO AND HAVE ACCESS TO THE HERO IFU, AS WELL AS THE HERO FAQ DOCUMENT.

    Description of Event or Problem · 1

    ACCORDING TO THE FEEDBACK, A CRYOLIFE REPRESENTATIVE HAS "THREE SURGEONS THAT DO 2-3 HERO GRAFTS A YEAR THAT ARE VERY CONCERNED WITH THE CURRENT SHEATH AND PLUG. THEY CONSIDER IT AN 'EMBOLISM WAITING TO HAPPEN.' PEOPLE LIKE (B)(6) [EXPERIENCED SURGEONS] AREN'T AS CONCERNED BECAUSE THEY KNOW HOW TO POSITION THE PATIENT CORRECTLY, HOLD BREATH, AND HOW TO HANDLE IT IF IT HAPPENS. OTHER SURGEONS MAY NOT BE AS TECHNICALLY SAVVY." ADDITIONAL INFORMATION FROM THE REPRESENTATIVE INDICATED THAT NO EVENTS OF EMBOLISM HAVE OCCURRED WITH THE THREE SURGEONS. ALL THREE OF THE SURGEONS (B)(6) HAVE EXPERIENCED INTERVENTIONAL RADIOLOGISTS WHO GO INTO SURGERY WITH THEM WHO ARE ALL USED TO USING DILATOR WIRES AND SHEATHS WITH VALVES.

    Description of Event or Problem · 1

    ACCORDING TO THE FEEDBACK, A CRYOLIFE REPRESENTATIVE HAS "THREE SURGEONS THAT DO 2-3 HERO GRAFTS A YEAR THAT ARE VERY CONCERNED WITH THE CURRENT SHEATH AND PLUG. THEY CONSIDER IT AN 'EMBOLISM WAITING TO HAPPEN.' PEOPLE LIKE LAWSON AND ROSS [EXPERIENCED SURGEONS] AREN'T AS CONCERNED BECAUSE THEY KNOW HOW TO POSITION THE PATIENT CORRECTLY, HOLD BREATH, AND HOW TO HANDLE IT IF IT HAPPENS. OTHER SURGEONS MAY NOT BE AS TECHNICALLY SAVVY." ADDITIONAL INFORMATION FROM THE REPRESENTATIVE INDICATED THAT NO EVENTS OF EMBOLISM HAVE OCCURRED WITH THE THREE SURGEONS. ALL THREE OF THE SURGEONS (DR. (B)(6) IN (B)(6) AND DRS. (B)(46 IN (B)(6) HAVE EXPERIENCED INTERVENTIONAL RADIOLOGISTS WHO GO INTO SURGERY WITH THEM WHO ARE ALL USED TO USING DILATOR WIRES AND SHEATHS WITH VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481442 HERO GRAFT ACCESSORY COMPONENT KIT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 1003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1