BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3971099 · Received July 31, 2014

    Report

    Report Number
    2017233-2014-00394
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED BELOW: A MINIMUM AORTIC NECK LENGTH OF 15 MM; KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION, SHORT PROXIMAL AORTIC NECK AND SIGNIFICANT THROMBUS AND / OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. THE US CLINICAL STUDIES QUANTIFY SIGNIFICANT THROMBUS AS THROMBUS ≥ 2 MM IN THICKNESS AND / OR ≥ 25% OF THE VESSEL CIRCUMFERENCE IN THE INTENDED SEAL ZONE OF THE AORTIC NECK.

    Description of Event or Problem · 1

    THE PATIENT REFERENCED IN THIS COMPLAINT FILE IS ENROLLED IN (B)(4) AS PART OF THE RENEWAL REIMBURSEMENT FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY IN THE TREATMENT OF INFRA-RENAL ABDOMINAL AORTIC ANEURYSMS. ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 56MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ENDOLEAK. THE PATIENT¿S AORTIC NECK LENGTH MEASURED 14MM WITH MAJOR CALCIFICATION. ON (B)(6) 2014 THE PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT RE-INTERVENTION ON (B)(6) 2013 FOR THE PROXIMAL TYPE I ENDOLEAK, AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE, HOWEVER THE ENDOLEAK WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447912 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10366273

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R