BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1559487 · Received December 10, 2009

    Report

    Report Number
    2031527-2009-00188
    Event Type
    Injury
    Date Received
    December 10, 2009
    Date of Event
    November 18, 2009
    Report Date
    December 8, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-95RL LOT NO. W09-0995-010. EXPIRATION DATE: 04/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. RESULTS/CONCLUSIONS: TREATMENT OF AORTIC NECK WITH <15MM LENGTH IS OFF-LABEL PER INDICATIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AORTIC NECK MEASURING 23MM TO 21MM OVER <15MM OF LENGTH, APPROXIMATELY 45 DEGREE ANGULATION, CALCIFICATION IN SEVERAL AREAS OF THE NECK AND ILIAC VESSELS, RENAL TO BIFURCATION 138MM; IN 2009, HAD IMPLANT OF A 28-16-140BL BIFURCATED DEVICE AND A 28-18-95RL SUPRARENAL PROXIMAL EXTENSION. IT WAS NOTED THAT THE PROXIMAL END OF THE BIFURCATED DEVICE LANDED IN THE "ELBOW" OF THE ANGLE. FOLLOW UP REVEALED A JUNCTIONAL TYPE III LEAK BETWEEN THE MAIN BODY AND THE SUPRARENAL CUFF. THREE MONTHS LATER, THE PATIENT WAS TREATED BY DEPLOYING AN ADDITIONAL 28-28-75L PROXIMAL EXTENSION AT THE JUNCTION BETWEEN THE MAIN BODY AND THE ORIGINAL CUFF. THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W09-0993-021

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention