BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1994063 · Received February 16, 2011

    Report

    Report Number
    2031527-2011-00007
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 3, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IMPLANT ON (B)(6) 2010 OF A 25-16-100BL BIFURCATED DEVICE AND A 34MM AORTIC EXTENSION. A (B)(6) 2010 FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH A 34MM AORTIC EXTENSION WHICH CORRECTED THE ENDOLEAK. SHOULD READ: PATIENT IMPLANT ON (B)(6) 2010 OF A 28-16-100BL BIFURCATED DEVICE AND A 34MM AORTIC EXTENSION. A (B)(6) 2010 FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH A 34MM AORTIC EXTENSION WHICH CORRECTED THE ENDOLEAK. LOT# READS: W10-2615-002. LOT# SHOULD READ: W10-2615-002.

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. IT IS UNKNOWN IF THE PATIENT ANATOMY MET 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) 2010 OF A 28-16-100BL BIFURCATED DEVICE AND A 34MM AORTIC EXTENSION. A (B)(6) 2010 FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH A 34MM AORTIC EXTENSION WHICH CORRECTED THE ENDOLEAK.

    Description of Event or Problem · 1

    PATIENT IMPLANT ON (B)(6) 2010 OF A 25-16-100BL BIFURCATED DEVICE AND A 34MM AORTIC EXTENSION. A (B)(6) 2010 FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH A 34MM AORTIC EXTENSION WHICH CORRECTED THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-100RLE W10-2615-002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention