BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3082631 · Received April 22, 2013

    Report

    Report Number
    2017233-2013-00250
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH TWO CONFORMABLE GORE TAG (CTAG) DEVICES TO TREAT AN AORTIC DISSECTION EXTENDING FROM THE DESCENDING THORACIC AORTA, DOWN TO AND INCLUDING THE CELIAC AND SUPERIOR MESENTERIC ARTERIES, AND INTO THE COMMON ILIAC ARTERIES. THE DISSECTION ALSO INCLUDED A THORACIC ANEURYSM COMPONENT. IT WAS REPORTED THE PT WAS ADMITTED TO THE ER AT NOON ON (B)(6) 2013, PRESENTING WITH CHEST AND BACK PAIN. HE IS A KNOWN ALCOHOLIC AND WAS INEBRIATED UPON ARRIVAL. THE PHYSICIAN CHOSE TO OPERATE LATER THAT EVENING; HE DEBRANCHED AND RESTORED BLOOD FLOW TO THE CELIAC AND SUPERIOR MESENTERIC ARTERIES. HE THEN IMPLANTED A CTAG DEVICE JUST PROXIMAL OF THE RENAL ARTERIES AND EXTENDED A SECOND CTAG DEVICE PROXIMAL OF THAT DEVICE UP TO THE DESCENDING THORACIC AORTA. THE PT TOLERATED THE PROCEDURE. REPORTEDLY, TWO HRS POST OP, THE PT LOST BLOOD PRESSURE AND THE PHYSICIAN THOUGHT THE ANEURYSM HAD RUPTURED; THE RUPTURE WAS NOT CONFIRMED. THE PHYSICIAN REINTERVENED AND EXPLANTED THE CTAG DEVICES AND WAS ATTEMPTING TO REPAIR THE ANEURYSM SURGICALLY, THE PT WENT INTO CARDIAC ARREST. THE PT EXPIRED ON (B)(6) 2013; THE PHYSICIAN IS NOT ATTRIBUTING THE CAUSE OF DEATH TO THE GORE DEVICES. THE CAUSE OF DEATH IS CARDIAC ARREST AND EXSANGUINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172570 GORE TAG THORACIC ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 11175729

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death