BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2041219 · Received April 6, 2011

    Report

    Report Number
    2031527-2011-00020
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.

    Additional Manufacturer Narrative · 1

    PATIENT ANATOMY DID NOT MEET THE CRITERIA FOR INDICATIONS FOR USE, THOMBUS AT THE ARTERIAL IMPLANTATION SITES. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH MILD THROMBOSIS IN THE ANEURYSM NECK; WHICH ALSO HAD A REVERSE CONICAL TAPER. THE PATIENT ALSO HAD A PREVIOUSLY IMPLANTED RENAL STENT GRAFT; WHICH APPEARED TO BE PROTRUDING FROM RENAL ARTERY PREVENTING THE USE OF A SUPRERENAL AORTIC EXTENSION. AFTER SUCCESSFUL DEPLOYMENT OF A (B)(4) BIFURCATED DEVICE AND AN 34 MM INFRARENAL 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 INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-80LE W10-0381-011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention