BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)

    MDR report key: 8022285 · Received October 30, 2018

    Report

    Report Number
    2953161-2018-00094
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 29, 2018
    Report Date
    August 19, 2019
    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 · 0

    G9: CORRECTED/ADDITIONAL INFORMATION TO INCLUDE THE 510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED FROM THE RIGHT SIDE, FOLLOWED BY TWO CONTRALATERAL LEG COMPONENTS IMPLANTED. WHEN TOUCH-UP BALLOONING WAS PERFORMED FOR THE CONTRALATERAL LEG COMPONENT ON THE RIGHT SIDE (PLC181200J/18013164) USING A GORE® MOLDING AND OCCLUSION BALLOON (MOB) CATHETER, THE PATIENT¿S RIGHT COMMON ILIAC ARTERY WAS RUPTURED. IT WAS REPORTED THAT THE PATIENT¿S COMMON ILIAC ARTERIES WERE CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO THE VESSEL RUPTURE. THE RIGHT INTERNAL ILIAC ARTERY WAS COI-EMBOLIZED AND ANOTHER CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO REPAIR THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858637 AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 18151600

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention