BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITRAK

    MDR report key: 5194438 · Received October 28, 2015

    Report

    Report Number
    2031527-2015-00424
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE LIMITED INFORMATION FOR THE CLINICAL ASSESSMENT, THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE ROOT CAUSE FOR THE REPORTED ISSUE WAS NOT DEFINITELY IDENTIFIED, BUT THE PATIENT ANATOMY WAS THE MOST LIKELY CAUSE. THE IDENTIFICATION OF A DESIGN OR MANUFACTURING ISSUE WAS INCONCLUSIVE. THE CLINICAL REVIEW HAD MINIMAL INFORMATION, BUT DID IDENTIFY THE FOLLOWING FACTORS: MISUSE OF THE DEVICE OUTSIDE THE RECOMMENDED USE OF THE DEVICE IN THE LEFT COMMON ILIAC ARTERY ANEURYSM OF 4.5 CM IN DIAMETER; THE RIGHT COMMON ILIAC ARTERY WAS ALSO ANEURYSMAL, BUT ITS DIAMETER COULD NOT DEFINITIVELY BE IDENTIFIED AS OVER 2.3 CM ON THE ANGIOGRAM STUDY.

    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 INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. OTHER DEVICES REMAIN IMPLANTED. ADDITIONAL DEVICES INFO: MODEL 16-16-88, LOT: W10-4103-029, RELEASE DATE: 01/05/2011, EXPIRATION DATE: 11/30/2013. MODEL : 20-13-88FL, LOT: W11-0580-006, RELEASE DATE: 02/25/2011 AND EXPIRATION DATE 01/31/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, AN INFRARENAL AORTIC EXTENSION AND THREE LIMB EXTENSIONS. UPON FOLLOW UP, AN ULTRASOUND REVEALED THE PATIENT HAD A LARGE LEFT ILIAC ANEURYSM. A DISTAL ENDOLEAK WAS IDENTIFIED AND THE ANEURYSM SAC HAD GROWN. THE RIGHT ILIAC WAS SLIGHTLY DILATED. THE PATIENT WAS TREATED WITH COIL EMBOLIZATION AND AN ADDITIONAL LIMB AORTIC EXTENSION. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713109 INTUITRAK LIMB MIH ENDOLOGIX 20-25-55S,16-16-88 W10-3006-006, W10-4103-029

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR