BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2348220 · Received November 23, 2011

    Report

    Report Number
    2031527-2011-00077
    Event Type
    Injury
    Date Received
    November 23, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. DEVICES WERE NOT RETURNED FOR EVALUATION. IT IS UNKNOWN IF THE PATIENT ANATOMY MET THE CRITERIA FOR INDICATIONS FOR USE. ANEURYSM ENLARGEMENT IS A KNOWN RISK OF THE PROCEDURE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT RECEIVED AN IMPLANT ON (B)(6) 2009 OF A BIFURCATED DEVICE AND THREE 34 MM AORTIC EXTENSIONS (REFERENCE MANUFACTURER REPORT NUMBERS 2031527-2011-00072, 2031527-2011-00078, AND 2031527-2011-00079). THE PATIENT WAS NOT FOLLOWED UP AND SUBSEQUENTLY PRESENTED WITH BACK PAIN AFTER FALLING. A COMPUTED TOMOGRAPHY SCAN REVEALED NO SIGNS OF ENDOLEAK; HOWEVER ANEURYSM SAC HAD GROWN FROM 6.1 CM, AT TIME OF IMPLANT, TO 6.8 CM. ON (B)(6) 2011 ALL DEVICES WERE EXPLANTED. DURING THE EXPLANT PROCEDURE THE PHYSICIAN NOTED NO ENDOLEAK. THE PATIENT IS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL AND HAS SINCE BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-80LE W09-1262-013

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention