BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO

    MDR report key: 3232684 · Received July 18, 2013

    Report

    Report Number
    3006945290-2013-00026
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    August 22, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, AN EVALUATION OF THE DEVICE WAS PERFORMED BY CRYOLIFE. THE HERO GRAFT WAS VISUALLY AND PHYSICALLY EVALUATED IN THE BIOLOGICAL SAFETY CABINET. THE EDGES OF THE TEAR LOOKED VERY SMOOTH AS IF A SCALPEL HAD CUT THROUGH THE GRAFT. A SMALL HOLE WAS FOUND NEAR THE TEAR. IT WAS POSSIBLE TO PROPAGATE THE TEAR BY HAND, BUT REQUIRED DIRECTIONAL AND INTENTIONAL FORCE. IT WOULD BE DIFFICULT TO BEGIN A TEAR IN THE HERO GRAFT WITHOUT A SHARP INSTRUMENT. IF THE GRAFT HAD TORN BY ITSELF, THE EDGES WOULD APPEAR JAGGED. IT IS LIKELY THAT USER ERROR INVOLVING A SHARP INSTRUMENT CAUSED THE TEAR. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SURGEON IMPLANTED A HERO DEVICE ON(B)(6) 2013 WITHOUT INCIDENT. IT WAS CONNECTED TO AN EXISTING GRAFT, NOT THE PATIENT¹S OWN ARTERY. THE PATIENT DEVELOPED A CLOT AND WAS BROUGHT TO ST. THOMAS HOSPITAL FOR A DECLOTTING PROCEDURE ON (B)(6) 2013. THE SURGEON USED A FOGERTY BALLOON TO PERFORM THE DECLOT USING PERCUTANEOUS TECHNIQUE. HIS FIRST PASS OF THE BALLOON WAS NEAR THE ARTERIAL ANASTOMOSIS WITH NO ISSUES. HE BELIEVES THAT THE BALLOON PASSED PERCUTANEOUSLY FROM THE CONNECTOR TOWARDS THE ARTERIAL ANASTOMOSIS. HE NOTICED THE PATIENT WAS DEVELOPING A HEMATOMA NEAR THE ARTERIAL ANASTOMOSIS. HE GOT CONTROL OF THE BLEEDING AND REMOVED THE ARTERIAL GRAFT COMPONENT (LOT 0001850) TO FIND THE GRAFT HAD SPLIT APPROXIMATELY 6-8CM. HE IMPLANTED A GORE PTFE GRAFT AND COMPLETED THE PROCEDURE. HE EXAMINED THE GRAFT ON THE BACK TABLE AND SLIGHTLY PRESSED ON THE SPLIT AND IT BEGAN TO SPLIT FURTHER. THE HEMOSPHERE IMPLANT LOG WAS SEARCHED; THE SURGEON WAS LISTED AS HAVING COMPLETED ONE PRIOR HERO GRAFT IMPLANT ON (B)(6) 2012. THE HERO GRAFT THROMBECTOMY GUIDELINES WERE REVIEWED; IN TWO PLACES IT IS STATED THAT A PERCUTANEOUS OR SURGICAL TECHNIQUE CAN BE USED TO DECLOT, BUT "A SURGICAL TECHNIQUE IS RECOMMENDED DURING THE GRAFT INCORPORATION PERIOD TO AVOID RISK OF SEROMA OR OTHER COMPLICATIONS." THE SAME WARNING IS ALSO INCLUDED IN THE HERO GRAFT FAQ. THE HEMOSPHERE DEVICE EXPERIENCE REPORT (DER) LOG WAS SEARCHED; THERE WAS ONE COMPLAINT INVOLVING THE HERO EPTFE GRAFT SPLITTING OPEN DURING A THROMBECTOMY, IT WAS ALSO A PERCUTANEOUS TECHNIQUE BEFORE THE GRAFT HAD INCORPORATED. THE SAMPLE WAS RETURNED TO CRYOLIFE FOR INVESTIGATION. ON (B)(6) 2013, THE HERO GRAFT WAS VISUALLY AND PHYSICALLY EVALUATED IN THE BIOLOGICAL SAFETY CABINET. THE EDGES OF THE TEAR APPEARED VERY SMOOTH AS IF THEY GRAFT HAD BEEN CUT BY A SCALPEL. A SMALL HOLE WAS FOUND NEAR THE TEAR. WHILE IT WAS POSSIBLE TO PROPAGATE THE TEAR BY HAND, THIS REQUIRED DIRECTIONAL AND INTENTIONAL FORCE. IT WOULD HAVE BEEN DIFFICULT TO BEGIN A TEAR IN THE HERO GRAFT WITHOUT A SHARP INSTRUMENT. BARD, THE MANUFACTURER OF THE EPTFE PORTION OF THE GRAFT, WAS CONTACTED WITH REGARD TO THIS CASE. IMAGES OF THE GRAFT WERE SENT, AND THE FOLLOWING RESPONSE WAS RECEIVED: "IT DEFINITELY LOOKS LIKE THE GRAFT WAS CUT AND THE CUT WAS PROPAGATED DOWN THE LENGTH OF THE GRAFT. THE TEAR IS TOO SMOOTH AND EVEN TO HAVE BEEN CAUSED BY DEVICE FAILURE OR RUPTURE FROM THE USE OF THE BALLOON." THE DEVICE HISTORY RECORDS FOR LOT 0001850 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 RECORD - (B)(4). IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE OF THIS EVENT FROM THE INFORMATION GATHERED DURING THIS INVESTIGATION. HOWEVER, IT IS HIGHLY LIKELY THAT THE EVENT WAS CAUSED BY USER ERROR; THE GRAFT DID NOT APPEAR TO BE INCORPORATED AT THE TIME OF THROMBECTOMY, AND THE TEAR APPEARS TO HAVE BEEN CAUSED BY A SHARP INSTRUMENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON IMPLANTED A HERO DEVICE ON (B)(6) 2013 WITHOUT INCIDENT. IT WAS CONNECTED TO AN EXISTING GRAFT, NOT THE PATIENT¿S OWN ARTERY. THE PATIENT DEVELOPED A CLOT AND WAS BROUGHT TO ST. THOMAS HOSPITAL FOR A DECLOTTING PROCEDURE ON (B)(6) 2013. THE SURGEON USED A FOGERTY BALLOON TO PERFORM THE DECLOT USING PERCUTANEOUS TECHNIQUE. HIS FIRST PASS OF THE BALLOON WAS NEAR THE ARTERIAL ANASTOMOSIS WITH NO ISSUES. HE BELIEVES THAT THE BALLOON PASSED PERCUTANEOUSLY FROM THE CONNECTOR TOWARDS THE ARTERIAL ANASTOMOSIS. HE NOTICED THE PATIENT WAS DEVELOPING A HEMATOMA NEAR THE ARTERIAL ANASTOMOSIS. HE GOT CONTROL OF THE BLEEDING AND REMOVED THE ARTERIAL GRAFT COMPONENT TO FIND THE GRAFT HAD SPLIT APPROXIMATELY 6-8CM. HE IMPLANTED A GORE PTFE GRAFT AND COMPLETED THE PROCEDURE. HE EXAMINED THE GRAFT ON THE BACK TABLE AND SLIGHTLY PRESSED ON THE SPLIT AND IT BEGAN TO SPLIT FURTHER. THE INITIAL SPLIT WAS APPROXIMATELY 2/3 THE LENGTH OF WHAT IS NOTED IN THE PICTURES AND THE GRAFT WHICH IS BEING RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIES THE LOT # AS 0001850. ADDITIONALLY, THE SURGEON STATED THAT THE ORIGINAL GORE GRAFT WAS MONTHS OLD. A 4 FOGARTY WAS USED FOR THE DECLOT PROCEDURE. NO OTHER DEVICES WERE USED. THE HERO GRAFT WAS NEVER PUNCTURED OR USED PRIOR TO THIS EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON IMPLANTED A HERO DEVICE ON (B)(6) 2013 WITHOUT INCIDENT. IT WAS CONNECTED TO AN EXISTING GRAFT, NOT THE PATIENT'S OWN ARTERY. THE PATIENT DEVELOPED A CLOT AND WAS BROUGHT TO ST. THOMAS HOSPITAL FOR A DECLOTTING PROCEDURE ON (B)(6) 2013. THE SURGEON USED A FOGERTY BALLOON TO PERFORM THE DECLOT USING PERCUTANEOUS TECHNIQUE. HIS FIRST PASS OF THE BALLOON WAS NEAR THE ARTERIAL ANASTOMOSIS WITH NO ISSUES. HE BELIEVES THAT THE BALLOON PASSED PERCUTANEOUSLY FROM THE CONNECTOR TOWARDS THE ARTERIAL ANASTOMOSIS. HE NOTICED THE PATIENT WAS DEVELOPING A HEMATOMA NEAR THE ARTERIAL ANASTOMOSIS. HE GOT CONTROL OF THE BLEEDING AND REMOVED THE ARTERIAL GRAFT COMPONENT TO FIND THE GRAFT HAD SPLIT APPROXIMATELY 6-8CM. HE IMPLANTED A GORE PTFE GRAFT AND COMPLETED THE PROCEDURE. HE EXAMINED THE GRAFT ON THE BACK TABLE AND SLIGHTLY PRESSED ON THE SPLIT AND IT BEGAN TO SPLIT FURTHER. THE INITIAL SPLIT WAS APPROXIMATELY 2/3 THE LENGTH OF WHAT IS NOTED IN THE PICTURES AND THE GRAFT WHICH IS BEING RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED THAT IDENTIFIES THE LOT # AS 0001850. ADDITIONALLY, THE SURGEON STATED THAT THE ORIGINAL GORE GRAFT WAS MONTHS OLD. A 4 FOGARTY WAS USED FOR THE DECLOT PROCEDURE. NO OTHER DEVICES WERE USED. THE HERO GRAFT WAS NEVER PUNCTURED OR USED PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334528 HERO VASCULAR GRAFT, PROSTHESIS DSY HEMOSPHERE, INC. HERO 1002 0001850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R