BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1599536 · Received February 4, 2010

    Report

    Report Number
    2031527-2010-00002
    Event Type
    Injury
    Date Received
    February 4, 2010
    Date of Event
    January 6, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-95RL LOT NO. W09-0995-018. EXPIRATION DATE: 04/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. INADVERTENT MISPLACEMENT DURING BALLOONING. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-95RL LOT NO. W09-0995-018 EXPIRATION DATE: 04/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. INADVERTENT MISPLACEMENT DURING BALLOONING. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH 18-23MM AORTIC NECK OVER 15MM LENGTH WITH 60 DEGREE ANGLE PROXIMALLY; IMPLANT OF A 28-16-120BL BIFURCATED DEVICE AND A 28-28-75L PROXIMAL EXTENSION. DURING BALLOON POST-DILATATION, THE PROXIMAL EXTENSION WAS INADVERTENTLY DISPLACED APPROXIMATELY 1.5CM INTO THE ANGLE OF THE NECK. A PALMAZ STENT WAS PLACED TO STRAIGHTEN OUT THE NECK. A 28-28-95RL SUPRARENAL CUFF WAS PLACED. THERE WAS A SLIGHT TYPE IA ENDOLEAK THAT WAS RESOLVED WITH A SECOND PALMAZ STENT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH 18-23MM AORTIC NECK OVER 15MM LENGTH WITH 60 DEGREE ANGLE PROXIMALLY; IMPLANT OF A 28-16-120BL BIFURCATED DEVICE AND A 28-28-75L PROXIMAL EXTENSION. DURING BALLOONING OF THE STENT GRAFT, THE PROXIMAL EXTENSION WAS INADVERTENTLY DISPLACED APPROXIMATELY 1.5CM INTO THE ANGLE OF THE NECK. A 28-28-95RL SUPRARENAL CUFF WAS PLACED. THERE WAS A SLIGHT PROXIMAL TYPE IA ENDOLEAK THAT WAS RESOLVED WITH A SECOND PALMAZ STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 28-28-75L W09-3503-012

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention