BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2370056 · Received March 11, 2010

    Report

    Report Number
    2031527-2010-00026
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 9, 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. W10-0010-002. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. UNKNOWN IF PATIENT ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A REVERSE CONICAL NECK WITH NO SIGNIFICANT ANGULATION. ACCESS AND DEPLOYMENT OF A BIFURCATED DEVICE AND A SUPRARENAL CUFF WERE UNEVENTFUL. AFTER POST-DILATATION BALLOONING, THERE WAS AN INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK THAT COULD NOT BE RESOLVED WITH ADDITIONAL BALLOONING. A PALMAZ STENT WAS PLACED TO RESOLVE THE ENDOLEAK WITH GOOD SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BUFURCATED STENT GRAFT, PRODUCT CODE: MIH MIH ENDOLOGIX, INC. 28-16-120BL W09-3752-002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention