BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 2884237 · Received December 21, 2012

    Report

    Report Number
    2031527-2012-00183
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, OPERATIVE NOTES, PROCEDURE PLANNING SHEETS AND COMPUTED TOMOGRAPHIC SCANS FROM BOTH PROCEDURES WERE PROVIDED FOR CLINICAL ASSESSMENT. THE PATIENT RETURNED FOR THEIR ONE YEAR FOLLOW UP, COMPUTED TOMOGRAPHIC SCANS REVEALED A TYPE 3 ENDOLEAK AND SEVERE RIGHT ANGLE OF THE LEFT LIMB WITH POTENTIAL FOR OCCLUSION. BASED ON REVIEW OF THE PROCEDURE PLANNING SHEET PERFORMED BOTH DURING INDEX PROCEDURE AND PRIOR TO SECONDARY PROCEDURE INDICATED THAT THE RENAL TO AORTIC BIFURCATION LENGTH MEASURED AT 104MM AND 115MM RESPECTIVELY. THE CAUSE FOR THE DISCREPANCY BETWEEN THE BASELINE AND 1 YEAR FOLLOW UP MEASUREMENTS OF THE RENAL TO AORTIC BIFURCATION LENGTH IS UNCLEAR. A CAUSE FOR THE TYPE 3 ENDOLEAK IS UNCLEAR; HOWEVER, CHANGES IN THE PATIENT'S ANATOMY OVER TIME MAY HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT'S VASCULAR ANATOMY (STRONG ANGULATION) CONTRIBUTED TO THE RIGHT ANGLE OF THE LEFT ILIAC LIMB. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOURTEEN MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION, A FOLLOW UP TOMOGRAPHY SCAN REVEALED AN ALLEGED TYPE III ENDOLEAK. (REFERENCE MEDWATCH # 2031527-2012-00182). APPROXIMATELY ONE MONTH LATER, THE PATIENT WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION. REPORTEDLY, DURING PLACEMENT OF THE ADDITIONAL INFRARENAL AORTIC EXTENSION, THE DEVICE WAS DELIVERED BEHIND THE STENT STRUT. THE PHYSICIAN USED A PALMAZ STENT TO FORCE THE EXTENSION PIECE OPEN AND THE ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C95 1026584-012

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR