BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 4120509 · Received September 26, 2014

    Report

    Report Number
    2017233-2014-00505
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS PENDING COMPLETION OF EVALUATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® DRYSEAL SHEATH INSTRUCTIONS FOR USE (IFU) STATES: IF VESSEL SIZE IS SMALLER THAN THE INTRODUCER SHEATH OUTER DIAMETER, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. A GORE® DRYSEAL SHEATH (DSL2228J/12556831) WAS INSERTED FROM THE PATIENT'S RIGHT SIDE TO IMPLANT THE CTAG DEVICES. IT WAS REPORTED THAT A STRONG RESISTANCE WAS FELT DURING THE ADVANCEMENT. THE DEVICES WERE IMPLANTED WITHOUT ISSUES. WHEN THE SHEATH WAS WITHDRAWN FROM THE PATIENT, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN SUSPECTED A RUPTURE OF THE ACCESS VESSEL AND IMPLANTED (B)(6) AND (B)(6) TO TREAT THE RUPTURE. THE PATIENT'S VITAL STABILIZED ONCE, BUT IT DROPPED AGAIN. THE PHYSICIAN PERFORMED AN OPEN ABDOMINAL SURGERY AND IDENTIFIED THE COMPLETE RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY. THE EXCLUDER COMPONENTS WERE EXPLANTED AND THE RUPTURED ILIAC ARTERY WAS RECONSTRUCTED WITH A VASCULAR GRAFT. TRANSFUSION WAS REPORTEDLY PERFORMED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE DIAMETER OF ACCESS VESSEL WAS SMALLER THAN THE SHEATH OUTER DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601295 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 12556831

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R