BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 6578404 · Received May 19, 2017

    Report

    Report Number
    3007284313-2017-00127
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    May 8, 2017
    Report Date
    May 25, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: TOPROL 50MG DAILY, CARDIZEM 300MG DAILY, APRESOLINE 50MG T.I.D., CLONIDINE 0.2MG T.I.D., ATORVASTATIN 10MG DAILY, PROTONIX 40MG DAILY, DILANTIN 300 MG DAILY, ARICEPT 5MG DAILY, B12 DAILY, FOLIC ACID, DAILY, IRON DAILY, ULTRAM P.R.N. PAIN. THE INSTRUCTIONS FOR USE FOR THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WARNS,: - ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE SHEATH INTO THE VASCULATURE. CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT. ¿ IF VESSEL SIZE IS SMALLER THAN THE NOMINAL BODY OD, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS ADVANCED USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND SUCCESSFULLY DEPLOYED. DURING THE PROCEDURE IT WAS REPORTED THAT THE ILIAC ARTERY WAS RUPTURED AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY (REIA). THE RUPTURE WAS CORRECTED BY PLACEMENT OF A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS PROXIMALLY, COVERING THE REIA; AND COVERAGE WITH GORE® VIABAHN® ENDOPROSTHESES DOWN TO THE COMMON FEMORAL ARTERY. IT WAS REPORTED THAT THE VESSEL DIAMETER AT THE LEVEL OF THE RUPTURE MEASURED 6MM. THERE WAS NO REPORTED RESISTANCE WHEN ADVANCING THE SHEATH OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358713 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 337048

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R