BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 4121014 · Received September 26, 2014

    Report

    Report Number
    3007284313-2014-00087
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 26, 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

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES ¿DO NOT CONTINUE ADVANCEMENT OR RETRACTION OF THE SHEATH OR DELIVERY CATHETER IF RESISTANCE IS FELT. STOP AND ASSESS THE CAUSE OF RESISTANCE. VESSEL DAMAGE MAY OCCUR.¿

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU404020J/12802496, TGU454520J/12768632) TO REPAIR A THORACIC AORTIC ANUERYSM. IT WAS REPORTED THAT THE PATIENT'S DISTAL NECK WAS EXTREMELY TORTUOUS. AFTER DEPLOYING TGU404020J/12802496 AT DISTAL SIDE SUCCESSFULLY, THE PHYSICIAN ATTEMPTED TO DEPLOY TGU454520J/12768632 PROXIMALLY; HOWEVER, THE DELIVERY CATHETER GOT STUCK AT THE TORTUOUS DISTAL NECK AND COULD NOT ADVANCE ANY FURTHER. IT WAS REPORTED THAT IN ORDER TO PASS THE DEVICE THROUGH THE TORTUOUS DISTAL NECK THE PHYSICIAN FORCIBLY ADVANCED IT AND SIMULTANEOUSLY ADDED FORCE TO A GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING (DSL2428J/12259308), RESULTING IN DISSECTION OF THE RIGHT COMMON ILIAC ARTERY. THE DISSECTION WAS REPAIRED BY IMPLANTING A BARE METAL STENT (DETAIL UNKNOWN) WITH SUCCESS. THE PHYSICIAN ELECTED NOT TO IMPLANT THE DEVICE. THE DEVICE WAS RETRACTED WITH NO OTHER REPORTED ISSUE AND THE PROCEDURE WAS CONCLUDED WITHOUT IMPLANTING ANY OTHER DEVICES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601386 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 12259308

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention