BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8825670 · Received July 25, 2019

    Report

    Report Number
    2017233-2019-00555
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 15, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A2: CORRECTED AGE. D6: ADDED IMPLANT DATE.

    Additional Manufacturer Narrative · 1

    THE FIRST DATE ANEURYSM GROWTH WAS VISIBLE WAS REPORTED TO BE IN 2013. SINCE NO EXACT DATE FOR THE ANEURYSM GROWTH WAS PROVIDED, (B)(6) 2013, WAS USED AS THE EVENT DATE. LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. IF LOT/SERIAL NUMBERS ARE OBTAINED, THE REVIEW WILL BE INCLUDED ON THE FINAL REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2007, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE FOLLOWING MAXIMUM DIAMETERS OF THE AORTIC ANEURYSM/LESION WERE REPORTED: 2011 ¿ 37 MM. 2012 ¿ 37 MM. 2013 ¿ 46 MM (LITTLE SIGN OF TYPE II ENDOLEAK). 2017 ¿ 65 MM (LITTLE SIGN OF TYPE II ENDOLEAK). (B)(6) 2018 ¿ 78 MM (NO ENDOLEAK). (B)(6) 2019 ¿ 80 MM (NO ENDOLEAK). ON (B)(6) 2019, THE ENDOPROSTHESIS WERE EXPLANTED. ACCORDING TO THE PHYSICIAN THE DEVICES HAD A PERFECT AND SOLID POSITION IN THE THREE SEALING POSITIONS. IT WAS STATED THAT THERE WAS NO EVIDENCE OF AN ENDOLEAK, BUT ONCE THE THROMBUS WAS REMOVED MINOR LUMBAR BLEEDING WAS REALIZED. ENDOTENSION IS ASSUMED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619258 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention