BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2853534 · Received December 3, 2012

    Report

    Report Number
    2031527-2012-00160
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 AND PROCEDURE PLANNING SHEET WERE PROVIDED FOR CLINICAL ASSESSMENT OF THE COMPLAINT BY CLINICAL REPRESENTATIVE. BASED ON THE REVIEW OF THE AVAILABLE MEDICAL RECORDS IT INDICATES THAT THE PATIENT PRESENTED WITH A TYPE 1 DISTAL ENDOLEAK APPROXIMATELY 33 MONTHS POST ABDOMINAL AORTIC ANEURYSM REPAIR WITH AN ENDOLOGIX STENT GRAFT. THE PATIENT'S ANATOMY (BILATERAL ECSTATIC ILIAC ARTERIES) LIKELY CONTRIBUTED TO THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION; A COMPUTED TOMOGRAPHY SCAN REVEALED A DISTAL TYPE I ENDOLEAK. REPORTEDLY, THE PATIENT CAME IN FOR A ROUTINE CHECKUP AT WHICH TIME A COMPUTED TOMOGRAPHY SCAN SHOWED THAT THERE WAS A DISTAL TYPE I ENDOLEAK FROM THE LEFT COMMON ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH TWO LIMB EXTENSIONS ON LEFT COMMON ILIAC AND ONE LIMB EXTENSION ON THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W09-3395-016

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention