BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 4241727 · Received November 10, 2014

    Report

    Report Number
    2017233-2014-00579
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    August 31, 2015
    Report Date
    December 14, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERFIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ENGINEERING EVALUATION STATED THAT NO FAILURE WAS DETECTED. ALL THREE DEVICES WERE EXPLANTED: PLEASE REFER TO FIELD FOR THE RESULTS OF THE ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE HAS TO BE CORRECTED TO (B)(6) 2011. FOLLOW UP VISITS WERE DONE AND FOLLOWING ANEURYSM DIAMETERS WERE MEASURED: (B)(6) 2011 65MM. (B)(6) 2012 65MM. (B)(6) 2012 61MM. (B)(6) 2013 60MM. (B)(6) 2013 65MM. (B)(6) 2014 81MM. (B)(6) 2015 84,7MM. (B)(6) 2015 92,8MM. FOLLOWING DEVICES WERE EXPLANTED: PXC161400 LOT 7511894 UDI: (B)(4). PXC161000 LOT 8212375 UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(6) 2015 RECEIVED PHONE CALL FROM STUDY COORDINATOR WITH THE FOLLOWING INFORMATION: THE TYPE II ENDOLEAK WAS TREATED SEVERAL TIMES WITHOUT SUCCESS AND THE PHYSICIAN DECIDED TO EXPLANT THE ENDOPROSTHESIS ON (B)(6) 2015. ON (B)(6) 2014 THE PATIENT RECEIVED AN ANGIOGRAPHY TRANSFEMORAL AND A COILING OF THE LUMBAR ARTERY. ON (B)(6)2014 THE PATIENT WAS TREATED WITH A COMPUTED TOMOGRAPHY GUIDED EMBOLIZATION OF THE LUMBAR ARTERY. THE TYPE II ENDOLEAK WAS SUCCESSFULLY TREATED WITH COIL EMBOLIZATION. ON (B)(6) 2015 THE PATIENT WAS TREATED WITH A COMPUTED TOMOGRAPHY GUIDED EMBOLIZATION OF THE LUMBAR ARTERY. THE TYPE II ENDOLEAK WAS SUCCESSFULLY TREATED WITH COIL EMBOLIZATION. ON (B)(6) 2015 THE PATIENT UNDERWENT OPEN SURGERY AND THE DEVICES WERE EXPLANTED. (B)(4), LOT 8231498, (B)(4). REFER TO FIELD FOR THE RESULTS OF THE IMAGING EVALUATION.

    Additional Manufacturer Narrative · 1

    PATIENT¿S MEDICATIONS: CONCOR, ASS HEXAL, SIMVASTATIN, LISINOPRIL, MONO CORAX, MOLISEHEXAL, TAMOXIFEN 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. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THERE IS ANEURYSM GROWTH DUE TO A PERSISTENT TYPE II ENDOLEAK. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DATED (B)(6) 2011, REVEALED ANEURYSM SAC ENLARGEMENT, 12MM OF GROWTH SINCE (B)(6) 2011. ON (B)(6) 2014, THE PHYSICIAN REINTERVENED AND PERFORMED ANGIOGRAPHY TRANSFEMORAL COILING OF THE LUMBAR ARTERY. THE ENDOLEAK WAS NOT RESOLVED AND THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723713 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8231498

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R| S