BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1923277 · Received December 13, 2010

    Report

    Report Number
    2031527-2010-00135
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES: INFRARENAL PROXIMAL EXTENSION STENT GRAFT. MODEL# 25-25-75L, LOT# W09-0747-010, EXPIRATION DATE: 03/01/2011. DEVICE MANUFACTURE DATE: 04/10/2009. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PATIENT ANATOMY DID MEET THE CRITERIA FOR INDICATIONS FOR USE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT IMPLANT ON (B)(6) 2009 OF A (B)(4) BIFURCATED DEVICE, AND TWO 25MM AORTIC EXTENSIONS AT (B)(6) MEDICAL CENTER. ON (B)(6) 2010, PATIENT PRESENTED IN (B)(6) HOSPITAL EMERGENCY ROOM COMPLAINING OF STOMACH PAIN. AN ANGIOGRAPHIC WORK UP REVEALED THE BIFURCATED DEVICE AND ONE OF THE AORTIC EXTENSIONS HAD SEPARATED CREATING A TYPE III ENDOLEAK. ON (B)(6) 2010 THE PATIENT RECEIVED TWO 28MM AORTIC EXTENSIONS AND AN AORTIC STENT WHICH CORRECTED THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W09-0678R-028

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention