BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2103428 · Received May 26, 2011

    Report

    Report Number
    2031527-2011-00032
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 1, 2011
    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

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. USE OF DEVICE WITH ANEURYSM NECK ANGLE GREATER THAN 60 DEGREES IS CONSIDERED OFF-LABEL PER INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

    READ: PATIENT PRESENTED WITH A SLIGHTLY CALCIFIED ANEURYSM NECK ANGLING RIGHT TO LEFT AT APPROXIMATELY 65 DEGREES. AFTER SUCCESSFUL DEPLOYMENT OF A 22-16-100BL BIFURCATED DEVICE AND A 28MM SUPRARENAL AORTIC EXTENSION, AN ANGIOGRAPHIC IMAGE REVEALED AN INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK THAT COULD NOT BE RESOLVED WITH ADDITIONAL BALLOONING. AN AORTIC STENT WAS PLACED WHICH RESOLVED THE LEAK. SHOULD READ: PATIENT PRESENTED WITH A SLIGHTLY CALCIFIED ANEURYSM NECK ANGLING RIGHT TO LEFT AT APPROXIMATELY 65 DEGREES. AFTER SUCCESSFUL DEPLOYMENT OF A 22-16-120BL BIFURCATED DEVICE AND A 28MM SUPRARENAL AORTIC EXTENSION, AN ANGIOGRAPHIC IMAGE REVEALED AN INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK THAT COULD NOT BE RESOLVED WITH ADDITIONAL BALLOONING. AN AORTIC STENT WAS PLACED WHICH RESOLVED THE LEAK.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A SLIGHTLY CALCIFIED ANEURYSM NECK ANGLING RIGHT TO LEFT AT APPROXIMATELY 65 DEGREES. AFTER SUCCESSFUL DEPLOYMENT OF A 22-16-100BL BIFURCATED DEVICE AND A 28MM SUPRARENAL AORTIC EXTENSION, AN ANGIOGRAPHIC IMAGE REVEALED AN INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK THAT COULD NOT BE RESOLVED WITH ADDITIONAL BALLOONING. AN AORTIC STENT WAS PLACED WHICH RESOLVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-115RL W11-0791-001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention