BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 4052695 · Received September 2, 2014

    Report

    Report Number
    2017233-2014-00451
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 2, 2013
    Report Date
    February 16, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 THE PATIENT WAS TREATED WITH ONYX EMBOLIZATION TO SOLVE TYPE II ENDOLEAK. AN INCREASE OF THE ANEURYSM SAC WAS NOT OBSERVED, THEREFORE THE ENDOLEAK WAS SOLVED. 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 ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS: ASS 100, METOHEXAL 47,5, LASIX 40, PANTOZOL 40, PRAVASTATIN 40, ALNAR 0,4, JANUVIA 100, NOVALGIN 1 G RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION: 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 ENDOLEAK AND ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES RMT281414/7980429, PXC181000/7116032, PXC141000/7615213, AND PXC201000/9156747. ON (B)(6) 2013, AT CTA IMAGE SHOWED THE ANEURYSM DIAMETER TO BE 59MM, WHICH WAS 8MM LARGER THAN THE PRE-TREATMENT SIZE (51MM). SUBSEQUENT CTA MEASUREMENTS WERE AS FOLLOWS: (B)(6) 2013, 54MM. (B)(6) 2014, 57MM. ON (B)(6) 2014, A TYPE II ENDOLEAK WAS DETECTED BY CTA ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY. ON (B)(6) 2014, THE TYPE II ENDOLEAK WAS TREATED BY MEANS OF COIL EMBOLIZATION. THE PATIENT DID WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534143 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7980429

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| H| O| R| O| R SEE H.10./11.
    1 79 YR Male Hospitalization| H| O| R| O| R SEE H.10./11.