BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 5130862 · Received October 2, 2015

    Report

    Report Number
    2031527-2015-00384
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL DEVICES: MODEL NUMBER: A34-34/C100-O20 SUPRARENAL AORTIC EXTENSION. LOT: 1031801-019. RELEASE DATE: 03/28/2012. EXPIRATION DATE: 02/28/2013.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED SAC GROWTH WITHOUT A DISCERNIBLE ENDOLEAK (AND PRESUMED CONVERSION), EXPLANT, THE URGENT PRESENTATION OF A SYMPTOMATIC ABDOMINAL ANEURYSM, AND FINAL PATIENT DISPOSITION COULD NOT BE ESTABLISHED DUE TO LACK OF INFORMATION. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. A DESIGN OR MANUFACTURING ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED BASED ON THE AVAILABLE INFORMATION, AND OVERALL, THE INVESTIGATION IS INCONCLUSIVE. HOWEVER, CAUTIONARY PRODUCT USE CONDITIONS WERE IDENTIFIED THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT AND INCLUDED: A TORTUOUS, CALCIFIED AORTIC NECK. PATIENT FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED THE PAINT'S' REFUSAL TO BE ADMITTED WHEN SAC GROWTH WAS NOTED IN (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED HAD A PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED AND SUPRARENAL AORTIC EXTENSION. SUBSEQUENTLY, PATIENT PRESENTED IN CLINIC WITH A GROWING AAA ON FOLLOW-UP (NOW 8 CM) IN MID (B)(6) 2015. THERE WAS NO DISCERNIBLE ENDOLEAK ON COMPUTED TOMOGRAPHY. THE AAA WAS PAPAPBLE, AND NON-TENDER ON INITIAL EXAM. ADMISSION WAS RECOMMENDED, BUT THE PATIENT REFUSED. THE PATIENT WAS OFFERED AN ENDOVASCULAR REPAIR TO CORRECT THE AAA ON (B)(6), BUT PATIENT AGAIN REFUSED. THEN, THE PATIENT RETURNED TWO WEEKS LATER WITH A SYMPTOMATIC AAA IN THE ER. THE GRAFT WAS EXPLANTED EMERGENTLY DUE TO THE GROWTH OF 5/5 TO 8 CM OVER TWO YEARS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655536 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I16-30 1032594-007

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR