BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3051590 · Received April 10, 2013

    Report

    Report Number
    2031527-2013-00070
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED, HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, OPERATIVE NOTES (INDEX PROCEDURE) AND OPERATIVE NOTES (SECONDARY PROCEDURE) WERE PROVIDED FOR CLINICAL ASSESSMENT BY A CLINICAL REPRESENTATIVE. BASED ON THE REVIEW, THE MOST LIKELY CAUSE FOR THE REPORTED TYPE I ENDOLEAK WAS DETERMINED TO BE DUE TO DISEASE PROGRESSION OR POSSIBLY POOR GRAFT APPOSITION TO THE AORTIC WALL. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS ASSOCIATED TO THIS LOT. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING UNDER POTENTIAL ADVERSE EVENTS. ADDITIONALLY, THE DEVICE INSTRUCTIONS FOR USE, UNDER WARNINGS AND PRECAUTIONS STATE: AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK MAY LEAD TO ANEURYSM RUPTURE. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT SUCH AS DUE TO NEGATIVE REMODELING OF THE ANEURYSM OR DISEASE PROGRESSION) SHOULD RECEIVE ENHANCED FOLLOW-UP. PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR ENDOLEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL EXTENSION AND A LIMB EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152031 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-80L W08-2928

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention