BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2830186 · Received November 13, 2012

    Report

    Report Number
    2031527-2012-00162
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, OPERATIVE NOTES AND CT REPORTS WERE PROVIDED FOR CLINICAL ASSESSMENT. BASED ON REVIEW OF THE MEDICAL RECORDS BY CLINICAL REPRESENTATIVE, THE PATIENT PRESENTED WITH AN AORTIC ANEURYSM MEASURING 6.8CM, AT THE TIME OF THE INITIAL PROCEDURE. AT THE FOUR YEAR FOLLOW UP THERE WAS AN INCREASE IN ANEURYSM SIZE TO 7.7 CM AND A PROXIMAL TYPE I ENDOLEAK. THE TYPE I ENDOLEAK WAS REPAIRED WITH PLACEMENT OF A SUPRARENAL AORTIC STENT. REVIEW OF THE MEDICAL RECORDS INDICATES THE PATIENT'S AORTA HAD A SIGNIFICANT ANGLE AND THIS MAY HAVE CONTRIBUTED TO THE TYPE I ENDOLEAK. PATIENT'S ANATOMY (NECK ANGULATION) MAY HAVE CONTRIBUTED TO THE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 54 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION; A COMPUTED TOMOGRAPHY SCAN SHOWED A PROXIMAL TYPE I ENDOLEAK. 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
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75L W08-0023-001

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention