BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 6059787 · Received October 27, 2016

    Report

    Report Number
    2017233-2016-00826
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 15, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED FOR THE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED. FOR THE SAME REASON, THE UDI FOR THIS DEVICE CANNOT BE PROVIDED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: PATIENT MEDICATION: ENOXAPARIN DURING THE HOSPITALISATION (REPLACING WARFARIN), DILTIAZEM, INDAPAMIDE, PERINDOPRIL, PANTOPRAZOLE, TAMSULOSIN. THE GORE® DRYSEAL SHEATH SDV 2428 WAS DISCARDED AT THE FACILITY AND THEREFORE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A PENETRATING AORTIC ULCER OF THE THORACIC AORTA AND WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS. A GORE DRYSEAL SDV 2428 WAS USED TO ACCESS THE RIGHT FEMORAL ARTERY. WHEN CLOSING THE ACCESS INCISION OF THE RIGHT FEMORAL ARTERY AT THE END OF THE PROCEDURE, A SLIGHT KINKING OF THE VESSEL WAS NOTED BUT THE PULSE BELOW WAS PERCEIVED AS BEING GOOD. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A THROMBOSED RIGHT FEMORAL ARTERY. IT IS BELIEVED THAT THE THROMBOSIS OCCURRED DURING THE NIGHT FOLLOWING THE INITIAL PROCEDURE AND THAT THE THROMBUS WAS CAUSED BY A DETACHMENT OF ATHEROSCLEROTIC PLAQUE. IN A SECONDARY SURGICAL PROCEDURE, A THROMBECTOMY AND AN ILIAC ANGIOPLASTY WAS PERFORMED AND THE ARTERY WAS REPAIRED WITH A PATCH. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711251 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R