BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1622543 · Received March 4, 2010

    Report

    Report Number
    2031527-2010-00020
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    February 8, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INADVERTENTLY DID NOT ADD LOT NO. FOR BIFURCATED DEVICE 25-16-120BL. LOT IS W08-0991-003.ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-75L LOT NO. W08-0666-001 EXPIRATION DATE: 04/01/2011.MODEL NO. 28-28-75L LOT NO. W08-1324-003 EXPIRATION DATE: 07/01/2011.REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. IT IS UNKNOWN IF PATIENT ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-75L LOT NO. W08-0666-001 EXPIRATION DATE: 04/01/2011.MODEL NO. 28-28-75L LOT NO. W08-1324-003 EXPIRATION DATE: 07/01/2011.(B) (4) REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. [(B) (4)] IT IS UNKNOWN IF PATIENT'S ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2008, PATIENT IMPLANT OF A 25-16-120BL BIFURCATED DEVICE AND TWO 28-28-75L PROXIMAL EXTENSIONS. 30 DAY FOLLOW UP REVEALED NO ISSUES. ON (B)(6) 2010, PATIENT PRESENTED TO THE ER, SYMPTOMATIC. CT IMAGING REVEALED A PROXIMAL TYPE III ENDOLEAK; A SEPARATION BETWEEN THE PROXIMAL CUFFS AND THE MAIN BODY OF THE BIFURCATED DEVICE, AND THE PROXIMAL CUFFS HAD THROMBOSED. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND ALL DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

    Description of Event or Problem · 1

    ON (B) (6) 2008 PATIENT IMPLANT OF A 25-16-120BL BIFURCATED DEVICE AND TWO 28-28-75L PROXIMAL EXTENSIONS. 30 DAY FOLLOW UP REVEALED NO ISSUES. ON (B) (6) 2010, PATIENT PRESENTED TO THE ER, SYMPTOMATIC. CT IMAGING REVEALED A PROXIMAL TYPE III ENDOLEAK; A SEPARATION BETWEEN THE PROXIMAL CUFFS AND THE MAIN BODY OF THE BIFURCATED DEVICE, AND THE PROXIMAL CUFFS HAD THROMBOSED. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND ALL DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W08-0991-003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R