BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITRAK

    MDR report key: 5355508 · Received January 8, 2016

    Report

    Report Number
    2031527-2016-00011
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 DEVICE: MODEL 20-25-65S LIMB AORTIC EXTENSION LOT: W09-0819-011 REL. DATE: 7/13/2009 EXP. DATE: 2/28/2010. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION CONFIRMED TYPE 2 ENDOLEAK. PRE-IMPLANT PATIENT DATA WAS NOT AVAILABLE FOR REVIEW. THE EVENT IS NOT A DESIGN OR MANUFACTURING RELATED ISSUE. DEVICE WAS NOT RETURNED, NO EVALUATION COMPLETED. BASED ON THE INVESTIGATION IT IS INCONCLUSIVE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. CONTRIBUTING FACTORS INCLUDE ANTIPLATELET THERAPY AND ECTASIA OF THE INTERNAL AND EXTERNAL ILIAC PRIOR TO THE INITIAL IMPLANT. PRODUCT LABELING SPECIFIES THE POTENTIAL FOR INCREASED RISK FOR ENDOLEAKS WITH THE PLACEMENT OF A STENT GRAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS. UPON FOLLOW UP, PATIENT WITH AN ECTATIC ILIAC ANEURYSM SHOWED THAT IT HAD GROWN. PHYSICIAN IMPLANTED 4 LIMB EXTENSIONS AND PATIENT IS NOW STABLE.

    Description of Event or Problem · 1

    CLINICAL EVALUATION CONFIRMED AN ENDOLEAK TYPE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13118 INTUITRAK LIMB AORTIC EXTENSION MIH ENDOLOGIX, INC. 20-25-55S W11-0498-007

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention