BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TRI-LOBE BALLOON CATHETER

    MDR report key: 3143025 · Received May 23, 2013

    Report

    Report Number
    2017233-2013-00332
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE AORTIC RUPTURE COULD NOT BE DETERMINED WITH THE PROVIDED INFO. REFER TO THE FOLLOWING MEDWATCH NUMBERS FOR INFO ON ADDITIONAL DEVICES INVOLVED IN THIS EVENT: #2017233-2013-00331 - CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS; 2953161-2013-00075 - GORE EXCLUDER AAA ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. A CONTRALATERAL LEG COMPONENT WAS ALSO IMPLANTED 3 CM ABOVE THE AORTIC BIFURCATION AND EXTENDED INTO THE COMMON ILIAC ARTERY. DURING BALLOONING OF THE TAG DEVICE, THE AORTA RUPTURED. IT WAS REPORTED THE RUPTURE WAS EITHER DUE TO OVER INFLATION OF THE BALLOON OR BALLOONING IN THE PT'S FRIABLE AORTA. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE RUPTURE, BUT BALLOONING OF THIS GRAFT REPORTEDLY RESULTED IN MORE BLEEDING. AT THIS POINT, THE PHYSICIAN ELECTED TO CONVERT THE PT TO OPEN REPAIR AND TREAT THE RUPTURE SURGICALLY. IT WAS REPORTED THE PT TOLERATED THE OPEN CONVERSION PROCEDURE WITH NO FURTHER ADVERSE EVENTS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228546 GORE TRI-LOBE BALLOON CATHETER DQY W.L. GORE & ASSOCIATES 9177596

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R ASPIRIN,| GLIPIZIDE| ZANTAC| ATENOLOL,| LIPITOR,| POTASSIUM,| HYDROCHLOROTHIAZIDE