BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 2912011 · Received January 11, 2013

    Report

    Report Number
    3006945290-2013-00012
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    September 27, 2013
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K121532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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 THE REPORT, THE MARKER BAND DISLODGED DURING A DECLOT PROCEDURE. ADDITIONAL INFORMATION FROM THE ACCESS CENTER NURSE INDICATED THAT THE PATIENT WAS TRANSFERRED TO A HOSPITAL ACROSS THE STREET FOR SURGICAL REMOVAL OF THE MARKER BAND; THE RETRIEVAL WAS DONE BY AN INTERVENTIONAL RADIOLOGIST AND THE PATIENT WAS SAID TO BE DOING WELL. THE NURSE ALSO STATED THAT SHE HAD REVIEWED THE THROMBECTOMY GUIDELINES AND THE PHYSICIAN HAD USED THE WRONG SIZE BALLOON. THE PHYSICIAN WAS CONTACTED AND HE SAID HE WOULD USE A SMALLER BALLOON IN THE FUTURE. FURTHER, THE PHYSICIAN EXPLAINED THAT THERE WAS SOME RESIDUAL CLOT, SO A MECHANICAL THROMBECTOMY WAS PERFORMED AND THIS IS WHEN THE MARKER BAND DISLODGED. THE IMAGES FROM THE DECLOT PROCEDURE DATED (B)(6) 2012 WERE REVIEWED. THE IMAGES SEEM TO INDICATE THAT AN 8MM CONQUEST BALLOON, WHICH IS NONCOMPLIANT, WAS INITIALLY USED AND THE MARKER BAND WAS STILL INTACT. THEY SWITCHED TO A FOGARTY BALLOON, WHICH IS COMPLIANT, FOR THE EPTFE PORTION AND COMPLETED THE THROMBECTOMY. SEVERAL IMAGES LATER, THE MAKER BAND IS NO LONGER ATTACHED TO THE VENOUS OUTFLOW COMPONENT. THE TIMING MATCHES THE DESCRIPTION GIVEN BY THE PHYSICIAN THAT THIS OCCURRED AFTER A MECHANICAL DEVICE WAS USED; MECHANICAL/ROTATIONAL DEVICES ARE CONTRAINDICATED IN THE THROMBECTOMY GUIDELINES. HOWEVER, THERE HAVE BEEN MULTIPLE PUBLICATIONS AND BROCHURES IN WHICH SURGEONS REPORT USING UNAPPROVED DEVICES IN THE HERO GRAFT. IT IS LIKELY THAT THE MARKER BAND DETACHED DUE TO THE PHYSICIAN'S THROMBECTOMY TECHNIQUE OF USING A TOO LARGE, NON-COMPLIANT, BALLOON AND USING A MECHANICAL THROMBECTOMY DEVICE. IF THE SILICONE IS DAMAGED FROM EITHER AN OVERINFLATED BALLOON OR A MECHANICAL DEVICE, IT COULD ALLOW THE MARKER BAND TO DISLODGE FROM THE VENOUS OUTFLOW COMPONENT. RESEARCH AND DEVELOPMENT PERFORMED A STUDY, (B)(4), TO ATTEMPT TO RECREATE THE MARKER BAND DISLODGEMENT FAILURE AS SEEN IN THIS COMPLAINT. THE 8MM CONQUEST BALLOON, THE NONCOMPLIANT BALLOON USED IN THIS EVENT, WAS USED TO SIMULATE A THROMBECTOMY IN WHICH THE BALLOON WAS BEHIND THE MARKER BAND, UNDERNEATH THE MAKER BAND, AND PAST THE MARKER BAND. FROM THE TESTING CONDUCTED IN THE STUDY, THE COMPLETE SEPARATION OF THE MARKER BAND FROM THE VENOUS OUTFLOW COMPONENT COULD NOT BE REPLICATED. HOWEVER, IN ALL TEST GROUPS IN WHICH THE BALLOON WAS PLACED EITHER HALF WAY OR ALL THE WAY PAST THE MARKER BAND, THERE WAS SOME SILICONE DELAMINATION THAT RANGED FROM SLIGHT TO SEVERE DEPENDING ON THE AGGRESSIVENESS WITH WHICH THE BALLOON WAS PULLED THROUGH THE VOC. THE RESULTS OF THE STUDY ALSO SHOW THAT DESPITE USING AN 8MM, NON-COMPLIANT BALLOON, THE VOC'S CLEAR AND WHITE SILICONE LAYERS AND MARKER BAND REMAIN INTACT WHEN THE BALLOON IS PLACED BEHIND THE MARKER BAND AND PRESSURIZED TO FIT THE SIZE OF THE VOC, AS INSTRUCTED IN THE HERO THROMBECTOMY GUIDELINES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING A DECLOT PROCEDURE THE MARKER BAND DISLODGED. THE PATIENT WAS TRANSFERRED TO A NEARBY HOSPITAL TO REMOVE THE MARKER BAND. THE MARKER BAND WAS SUCCESSFULLY REMOVED AND THE PATIENT IS SAID TO BE DOING WELL.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING A DECLOT PROCEDURE THE MARKER BAND DISLODGED. THE PATIENT WAS TRANSFERRED TO A NEARBY HOSPITAL TO REMOVE THE MARKER BAND. THE MARKER BAND WAS SUCCESSFULLY REMOVED AND THE PATIENT IS SAID TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18632 HERO GRAFT VASCULAR GRAFT - PROSTHESIS DSY HEMOSPHERE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other