BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)

    MDR report key: 8026940 · Received October 31, 2018

    Report

    Report Number
    3013164176-2018-00101
    Event Type
    Death
    Date Received
    October 31, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 4, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    UDI-DI
    00733132618590
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC DISSECTION. THE PATIENT HAD TORTUOUS ANATOMY. IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THE CONFORMABLE GORE® TAG® (TGU454515/16605635), THE PATIENT HAD A BOVINE ARCH AND THE PHYSICIAN BYPASSED THE RIGHT CAROTID ARTERY TO THE LEFT CAROTID ARTERY AND THEN TO THE LEFT SUBCLAVIAN ARTERY (LSA). THE PHYSICIAN PLUGGED THE LSA AND LIGATED THE LEFT CAROTID VERTEBRAL ARTERY COMING OFF THE AORTIC ARCH. THE PHYSICIAN CONFIRMED THROUGH ANGIOGRAPH THAT THE CIRCLE OF WILLIS WAS INTACT AND THE BYPASSES WERE PATENT. THE PHYSICIAN THEN IMPLANTED A GORE® CONTRALATERAL LEG ENDOPROSTHESIS (PLC21000/1801573) INTO THE INNOMINATE ARTERY AS A SNORKEL GRAFT. THE PHYSICIAN IMPLANTED THE CONFORMABLE GORE® TAG® (TGU454515/16605635), BY ACCESS THROUGH THE BRACHIOCEPHALIC ARTERY. WHILE ATTEMPTING TO IMPLANT A SECOND CONFORMABLE GORE® TAG® (TGU454515/17353197), THERE WAS DIFFICULTY GETTING THE GUIDEWIRE FROM THE INNOMINATE ARTERY INTO THE ASCENDING AORTA. THE GUIDEWIRE WOULD CONTINUE TO BE PULLED OUT OF THE ASCENDING AORTA INTO THE TRANSVERSE AORTA. THE PHYSICIAN ATTEMPTED FOR OVER AN HOUR TO GET THE GUIDEWIRE INTO POSITION TO DELIVER THE CONFORMABLE GORE® TAG® DEVICE INTO DEPLOYMENT LOCATION. THE CONFORMABLE GORE® TAG® (TGU454515/17353197) WAS NOT IMPLANTED IN THIS CASE. THE PHYSICIAN CHOSE TO ABORT THE CASE AND MONITOR THE PATIENT. THE PATIENT WAS STABLE AND ALL GRAFTS WERE PATENT. THE PHYSICIAN DID NOT WANT TO PERFORM AN OPEN REPAIR DUE TO A PREVIOUS STERNOTOMY. THE PATIENT WAS EXTUBATED LATER THAT EVENING. ON (B)(6) 2018, THE PATIENT BECAME BRADYCARDIC AND CODED. THE PATIENT EXPIRED. DUE TO FAMILY NOT WANTING AN AUTOPSY, THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865919 AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 18015873 00733132618590

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death