BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3171249 · Received June 14, 2013

    Report

    Report Number
    2031527-2013-00126
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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): REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND THEREFORE, DEVICE EVALUATION COULD NOT BE PERFORMED. CLINICAL ASSESSMENT OF THE RECORDS PROVIDED FOR REVIEW INDICATED THAT THERE WAS SIGNIFICANT LATERAL MOVEMENT OF THE AORTA WHICH CONTRIBUTED TO THE SEPARATION OF THE STENT GRAFT COMPONENTS. THE LATERAL MOVEMENT IS LIKELY ATTRIBUTED TO ANEURYSMAL DISEASE PROGRESSION LEADING TO REMODELING OF THE AORTA. THERE IS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN AORTIC EXTENSION, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY SCAN REVEALED A TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND THE AORTIC EXTENSION. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY SCAN REVEALED A TYPE III ENDOLEAK BETWEEN THE INFRARENAL AORTIC EXTENSION AND THE BIFURCATED DEVICE. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270974 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75L W09-2053-016

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention