BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2903600 · Received January 2, 2013

    Report

    Report Number
    2017233-2012-00873
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 17, 2009
    Report Date
    December 14, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAKS, REOPERATION. FURTHERMORE, KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SIGNIFICANT THROMBUS AND/OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES. RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECS. CONCLUSION - "USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES".

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT ENDOVASCULAR REPAIR FOR A THORACIC AORTIC ANEURYSM WITH GORE TAG THORACIC ENDOPROSTHESIS. PRIOR TO IMPLANT OF THE TAG DEVICES, BYPASS SURGERY FROM RIGHT SUBCLAVIAN TO LEFT SUBCLAVIAN ARTERY WAS PREFORMED. THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2009, THE PT DEVELOPED PARAPARESIS AND RECEIVED REHABILITATION. ON (B)(6) 2009, STILL HOSPITALIZED, A SLIGHT TYPE II ENDOLEAK, ORIGINATING FROM THE LEFT SUBCLAVIAN ARTERY WAS DETERMINED, AND COIL EMBOLIZATION WAS PREFORMED. THE PT TOLERATED THE PROCEDURE. THE PT WAS REPORTED TO HAVE SIGNIFICANT CALCIUM PRESENT IN THE PROXIMAL AND DISTAL THORACIC NECK. THE PT WAS DISCHARGED ON (B)(6) 2010 AND THE PT HAS NOT FOLLOWED UP WITH THE PHYSICIAN SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06822729

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R| S