BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2200682 · Received July 28, 2011

    Report

    Report Number
    2017233-2011-00377
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 27, 2011
    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

    METHOD: A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM WITH GORE TAG THORACIC ENDOPROSTHESES. DURING THE FINAL BALLOONING WITH A GORE TRI-LOBE BALLOON CATHETER, THE PHYSICIAN OVER-INFLATED THE BALLOON, AND THE PATIENT'S BLOOD PRESSURE DROPPED. AORTIC DAMAGE AROUND THE DISTAL END OF THE MOST DISTAL DEVICE (B)(4) WAS IDENTIFIED, POSSIBLY A RUPTURE OR DISSECTION. ANOTHER TAG DEVICE (B)(4) WAS PLACED TO REPAIR THE AORTIC DAMAGE, BUT DURING TOUCH-UP BALLOONING AT THE JUNCTION AREA, CARDIAC ARREST OCCURRED. CARDIAC FUNCTION WAS RESTORED, BUT A TYPE III ENDOLEAK WAS IDENTIFIED, REQUIRING ANOTHER TAG DEVICE. THE ENDOLEAK RESOLVED WITH PLACEMENT OF THE ADDITIONAL STENT-GRAFT, AND THE PATIENT'S PULSE AND BLOOD PRESSURE RETURNED TO NORMAL. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVACULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG426 8950684

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R (B)(4)/#8917452