BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6204513 · Received December 27, 2016

    Report

    Report Number
    3007284313-2016-00262
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE BILATERAL INTERNAL ILIAC ARTERIES WERE COIL EMBOLIZED BEFORE THE PROCEDURE. THE ENDOPROSTHESIS WAS DEPLOYED WITH NO ISSUES. AFTER TOUCH-UP BALLOONING WAS PERFORMED, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ADDITIONAL TOUCH-UP BALLOONING TO THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS PERFORMED. INTRA-PROCEDURE ANGIOGRAPHY THEN SHOWED AN ABDOMINAL AORTIC DISSECTION BELOW THE RIGHT RENAL ARTERY. ALSO, THE POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS STILL OBSERVED, SO AN AORTIC EXTENDER COMPONENT WAS IMPLANTED PROXIMAL TO THE TRUNK-IPSILATERAL LEG COMPONENT. AT THAT TIME, A LITTLE PORTION OF THE ORIGIN OF THE LEFT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY THE AORTIC EXTENDER COMPONENT. ALTHOUGH, BLOOD FLOW TO THE LEFT RENAL ARTERY WAS MAINTAINED, THE PHYSICIAN ELECTED TO IMPLANT A STENT IN THE ARTERY. A GUIDEWIRE WAS ADVANCED INTO THE ARTERY FROM THE LEFT ARM. HOWEVER, A GUIDING CATHETER WOULD NOT BE ADVANCED, AND THE PHYSICIAN ELECTED NOT TO IMPLANT THE STENT IN THE LEFT RENAL ARTERY. THE PROCEDURE WAS CONCLUDED. THE PATIENT EXITED FROM THE ROOM UNDER INTUBATION WITH CONTROL OF THE BLOOD PRESSURE. IT WAS REPORTED THAT THE DISSECTION WAS ADVANCED RETROGRADELY DURING THE PROCEDURE, AND FINALLY IT INVOLVED THE ASCENDING THORACIC AORTA. APPROXIMATELY 3 HOURS AFTER THE PROCEDURE WAS CONCLUDED, THE PATIENT EXPERIENCED A RUPTURE OF THE AORTA AND THEN EXPIRED. IT WAS REPORTED THAT A CARDIAC TAMPONADE DUE TO THE RUPTURE OF THE AORTA OR BLOOD LOSS DUE TO THE RUPTURE OF THE AORTA WAS CONSIDERED AS THE CAUSE OF THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855281 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15159461

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R (B)(4)