BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4867071 · Received June 24, 2015

    Report

    Report Number
    2017233-2015-00377
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    February 6, 2015
    Report Date
    August 14, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. REFER TO THE RESULTS OF THE IMAGING EVALUATION. REINTERVENTION IMAGES WERE REQUESTED BUT NOT AVAILABLE. 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 ENDOLEAK. ADDITIONALLY, THE IFU STATES THAT KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SIGNIFICANT THROMBUS AND/OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES. FURTHERMORE, POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS MAY INCLUDE ENDOLEAKS AND IMPROPER COMPONENT PLACEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS EMERGENCY PRESENTED AT THE HOSPITAL. ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. IT WAS REPORTED THAT AN ENDOLEAK WAS NOT NOTED DURING THE IMPLANT PROCEDURE. HOWEVER, THE FINAL PIGTAIL RUN FOLLOWING THE BALLOONING OF THE DEVICE SHOWED SOME CONTRAST BETWEEN THE TOP OF THE MAIN BODY AND THE LEFT PART OF THE AORTIC WALL JUST BELOW THE RENAL ARTERIES. THEREFORE, THE PHYSICIAN DECIDED TO REBALLOON THE ENDOPROSTHESIS WHICH APPEARED TO REDUCE THE BLUSH OF CONTRAST. THE ANEURYSM APPEARED TO BE SEALED DESPITE LESS THAN SUPERIOR WALL APPOSITION AT PROXIMAL END OF TRUNK OVER FIRST 2CM. IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT¿S HEMOGLOBIN LEVELS DROPPED. THE IMMEDIATE POST-IMPLANT COMPUTED TOMOGRAPHY SCAN SHOWED A PROXIMAL TYPE I ENDOLEAK AT THE POSTERIOR ASPECT OF AORTA. THE PROXIMAL PART OF THE TRUNK DID NOT HAVE THE POSTERIOR WALL APPOSITION. THERE WAS CALCIUM POSTERIORLY ABOUT 2CM FROM PROXIMAL END OF THE DEVICE BETWEEN THE TOP OF THE TRUNK AND THE FLOW DIVIDER WHICH POSSIBLY CONTRIBUTED TO THE LACK OF POSTERIOR WALL APPOSITION. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN WAS MONITORING THE PATIENT. ON (B)(6) 2015, THE PATIENT UNDERWENT THE REINTERVENTION AND A FENESTRATED CUFF FROM VASCUTEK LTD., TERUMO WAS IMPLANTED TO PROVIDE A BETTER SEALING OF AN AORTIC ANEURYSM AND FIX A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408544 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12968084

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R