BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1586994 · Received January 14, 2010

    Report

    Report Number
    2031527-2009-00198
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 11, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL INFO: MODEL NO 34-34-80L, LOT NO W09-0749-028. EXPIRATION DATE: 04/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. TREATMENT OF AORTIC NECK WITH 90 DEGREE ANGLES IS OFF-LABEL PER INDICATIONS FOR USE.

    Description of Event or Problem · 1

    PT PRESENTED WITH A CONICAL NECK MEASURING 32MM TO 23MM OVER 25MM OF LENGTH, TWO 90 DEGREE ANGLES IN THE NECK (OFF-LABEL), RENAL TO BIFUR MEASURING OVER 115MM; IN 2009, HAD IMPLANT OF A 28-16-140BL BIFURCATED DEVICE AND TWO 34MM PROXIMAL EXTENSIONS. FOLLOW UP CT REVEALED APPROX 2 CM DISTAL MIGRATION OF THE MOST PROXIMAL EXTENSION, WITH A TYPE IA ENDOLEAK. FOUR MONTHS LATER, THE PT WAS TREATED WITH AN ADDITIONAL CUFF. AN ATTEMPT WAS MADE WITH A 34MM PROXIMAL EXTENSION, HOWEVER, THE PHYSICIAN WAS UNABLE TO ACCESS ON THE RIGHT SIDE DUE TO 6MM ILIAC. THE DEVICE WAS REMOVED AND A NEW EXTENSION WAS INTRODUCED. DUE TO THE ANGULATION, THE PROXIMAL EXTENSION WAS INADVERTENTLY DEPLOYED ABOUT 1CM BELOW THE RENALS; SLIGHT LEAK ON ANGIOGRAM. AN ATTEMPT WAS MADE TO PLACE A PALMAZ STENT, HOWEVER UNABLE TO ACCESS AND ADVANCE PAST THE ANGULATION. THE DECISION WAS MADE TO STOP THE PROCEDURE AND MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 34-34-80LE W09-1920-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention